Archive for the ‘Bone Marrow Stem Cells’ Category

Fast-track status is granted for frontotemporal dementia, next to the existing designation for traumatic spinal cord injury

GELEEN, Netherlands, Sept. 8, 2022 /PRNewswire/ -- The European Union has grantedstem cell biotech Neuroplastan orphan medicinal product designation for the applicability of its stem cell technology platform to frontotemporal dementia (FTD), following a positive opinion from The European Medicines Agency (EMA). With the existing orphan disease designation (ODD) for traumatic spinal cord injury (TSCI), Neuro-Cells is now approved for a fast-track development pathway with market exclusivity for both a trauma-induced and a chronic degenerative central nervous system disorder. This marks an important milestone in the development roadmap of Neuroplast's Neuro-Cells platform, as a stepping stone to other chronic neurodegenerative diseases such as Alzheimer's, ALS and Parkinson's Disease. The potential width in therapeutic applicability of the Neuroplast technology gives perspective to millions of people suffering from neurodegenerative diseases that currently have no outlook on effective treatment.

One technology addresses underlying mechanisms of multiple acute and chronic neurological disorders

Several conditions of the central nervous system, even when they seem unrelated at first and may have distinctive causes, have similar underlying disease mechanisms in common. These include unprogrammed cell death boosted by inflammation. Neuro-Cells, an autologous, bone-marrow derived Advanced Therapy Medicinal Product, addresses that disease mechanism by moderating inflammation of damaged cells in the central nervous system, to limit further impairment. The treatment objective in acute disorders is to limit impact of sudden injury, where the treatment objective in chronic disorders is to limit progression of the disease.

Neuroplast is already running a fast-track development pathway for traumatic spinal cord injury (TSCI), with a Phase II clinical trial in progress. This designation for frontotemporal dementia illustrates the broader applicability of the same technology for acute as well as chronic neurodegenerative disorders, paving the way to explore further applicability to conditions such as ALS, Alzheimer's disease, traumatic brain injury, subarachnoid stroke and Parkinson's Disease.

Orphan disease designation for FTD awarded based on pre-clinical evidence

Orphan disease designations are restricted to products for rare conditions for which there are no satisfactory methods of treatment authorized. It allows for a faster market authorization pathway and ten-year market exclusivity.

Frontotemporal dementia (FTD) is a degenerative condition in the brain that affect approximately 3.8 people in 10,000 persons in the EU. Typical survival rate lies between three and fourteen years from symptom onset, dependent on the FTD variant at play.

For this approval, the European Union followed the positive opinion from the EMA after the EMA followed positive recommendations from the Committee for Orphan Medicinal Products (COMP). COMP partly based their conclusions on the availability of pre-clinical evidence in mice, that showed decrease in neuroinflammation markers and rescue of cognitive and social behavioral deficits. Examples include reduction of anxiety, depressive-like behavior and abnormal social behavior.

Neuroplast CEO Johannes de Munter states:

"This designation for frontotemporal dementia is an important milestone in expanding the Neuro-Cells development to a wider range of therapeutic areas. Using the same technology platform for traumatic spinal cord injury and frontotemporal dementia, illustrates an unusual range of acute and chronic neurological disorders that could potentially benefit from this."

Neuroplast is open to discuss investor opportunities to effectuate the clinical pathways to a wider scope of neurological conditions.

About Frontotemporal dementia

Frontotemporal dementia (FTD) is a degenerative condition in the brain that is characterized by behavioral and language impairments. Depending on the variant, patients experience changes in personality, emotion, speech or motor functions. Patients may first become indifferent or careless and have difficulty understanding sentences. While the condition progresses, patients may become language impaired, lack initiative and lose executive functions. The typical survival rate lies between three and fourteen years from symptom onset, dependent on the FTD variant at play.

FTD affects approximately 3.8 people in 10,000 persons in the EU, for whom there are no effective treatments available. Patients typically receive antipsychotics to limit behavioral symptoms.

About Neuro-Cells

Neuro-Cells is a transformative treatment under GMP. It contains non-substantially manipulated bone marrow-derived hematopoietic and mesenchymal stem cells, manufactured from a patient's own bone marrow (donor and receiver are the same person). Inflammatory inducing components and pathogens are removed during this process.

About Neuroplast

Neuroplast is a Dutch stem cell technology company focusing on fast-track development programs using autologous cell products for treatment of neurodegenerative diseases, with the aim of giving back perspective to people who suffer from those conditions.

The company was founded in August 2014 by physician Johannes de Munter and neurologist Erik Wolters. Current funders are Lumana Invest, Brightlands Venture Partners, LIOF and the Netherlands Enterprise Agency. Neuroplast is located at Brightlands Chemelot Campus in The Netherlands.

For more information, please visite http://www.neuroplast.com

About Lumana Invest

Investment company Lumana was established by entrepreneurs and unique due to not having a predetermined investment horizon. The Lumana founders showcase strong commitment to their portfolio companies by actively supporting management in strategic decision making.

About Brightlands Venture Partners

Brightlands Venture Partners (BVP) is the fund manager of Chemelot Ventures and is a so-called ecosystem investor. BVP invests in companies benefiting from and contributing to the Brightlands campuses in the south of The Netherlands. Other funds under management are BVP Fund IV, Brightlands Agrifood Fund and Limburg Ventures. The funds of BVP focus on sustainability and health; together the funds have made over 40 investments.

About LIOF

LIOF is the regional development agency for Limburg and supports innovative entrepreneurs with advice, network and financing. Together with entrepreneurs and partners, LIOF is working towards a smarter, more sustainable and healthier Limburg by focusing on the transitions of energy, circularity, health and digitalization.

About The Netherlands Enterprise Agency

The Netherlands Enterprise Agency operates under the auspices of the Dutch Ministry of Economic Affairs and Climate Policy. It facilitates entrepreneurship, improves collaborations, strengthens positions and helps realize national and international ambitions with funding, networking, know-how and compliance with laws and regulations.

Forward looking statements

All statements other than statements of historical facts, including the statements about the clinical and therapeutic potential and future clinical milestones of Neuro-Cells, the indications we intend to pursue and our possible clinical or other business strategies, and the timing of these events, are forward-looking statements. Forward-looking statements can be identified by terms such as "believes", "expects", "plans", "potential", "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management's current beliefs and assumptions about future events and on information currently available to management. Neuroplast B.V. does not make any representation or warranty, express or implied, as to the improper use of this article, accuracy, completeness or updated status of above-mentioned statements. Therefore, in no case whatsoever will Neuroplast B.V. be legally liable or liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

In case of any further questions, please contact:

Neuroplast

Johannes de Munter, CEOT: +31 (0)85 076 1000E: [emailprotected]

LifeSpring LifeSciences Communication, Amsterdam

Leon MelensT: +31 6 538 16 427E: [emailprotected]

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Neuroplast receives second orphan medicinal product designation for Neuro-Cells, paving the way for application to both chronic and trauma-induced...

By Mylika Scatliffe, AFRO Womens Health Writer

NKiia Stallworth, 42 of Providence, R.I. needs a match. Her multiple myeloma is not an incurable disease. In fact, you could be the solution she needs.

Stallworth and others like her can be cured by a blood stem cell transplant.

Multiple myeloma is a cancer of the plasma cells. As defined by the Center for Disease Control and Prevention (CDC), plasma cells are white blood cells that make antibodies that protect us from infection. In myeloma the cells grow too much, crowding out normal cells in the bone marrow that make red blood cells, platelets, and other white blood cells. Multiple myeloma is the most common type of plasma cell tumor. It develops in the bone marrow and can spread throughout the body.

The challenge for Stallworth is that Black patients have a 29 percent chance of finding a donor match, compared with a 79 percent chance for White patients. White and Black patients searching for a donor have drastically different experiences due to the fact that there simply are not enough registered Black donors.

Be The Match is an organization that facilitates blood stem cell transplants in efforts to replace a patients malformed blood cells with healthy ones. A majority of the time, donations are collected through a non-surgical procedure. Blood is collected from one of the donors arms, the needed cells are extracted and the blood is returned to the body. The process is similar to donating plasma.

Stallworth was diagnosed with multiple myeloma roughly 14 months ago. She admittedly went through a lot of emotions upon initially receiving her diagnosis and didnt even really want to talk about it. Then she found out she needed a blood stem cell transplant.

I didnt even know this was a thing until I was diagnosed. We as minorities really need to give blood in order for us to have a chance at this life-saving cure, and so no one has to wait for a year or even longer, hoping to get a match, said Stallworth.

A patients chance of having a matched available donor on the registry ranges from 29 percent to 79 percent, depending on the patients ethnic background. Because the genetic markers used in matching are inherited, donors are most likely to find a match with someone of the same ethnic background. More than 75 different diseases including leukemia and lymphoma, aplastic anemia, multiple myeloma, sickle cell disease, and immune -deficiency disorders can be cured or treated with a blood stem cell transplant.

Only 8 percent of Be The Match registrants identify as Black or African American.

Erica Jensen, vice president of marketing and a member of the engagement, enrollment, and experience team at Be The Match, said one of her main responsibilities is to increase the diversity of the registry.

Historically marketing was mostly in White communities and there was not enough emphasis, relationships, and programs to connect with more diverse communities. We are committed to changing that, said Jensen. Among other things, weve hired more diverse staff, and created an HBCU intern program which is being expanded to include 30 HBCUs.

Jensen further explained encountering barriers because of medical mistrust because of the way Black bodies have been treated and the history of predatory practices against Black people.

We are very careful and transparent in answering peoples questions. No, we will not share your DNA with police databases or governmental agencies. Yes, the doctors will hold your safety in as high regard as the recipient patient as the donor patient. No, your stem cells will not be taken to only help White and/or rich people, said Jensen.

Be The Match makes sure to take care of any needs for a donor. When a match is found everything is made convenient for the donor including choosing a collection center close to the donor. However, if travel and accommodations are needed for the donor, it is covered at no cost to the donor, including a travel companion for the donor if needed.

More likely than not a donor will just go to a collection center near them. But, for example, if youre in Nebraska you may need to go to a collection center in Seattle or somewhere in Texas, we will book and cover your accommodations. If you need to take an Uber across town to the appointment, its taken care of. If you need to pay a babysitter or dogwalker so you can donate, its at no cost to you.

As noted above, the collection process is simple. Ahead of the collection, the donor receives daily injections for five days to stimulate the bodys stem cells. A donor can go to a center to have the injections completed or be provided a kit to do the injections at home.

About 85 percent of the time donations are achieved through non-surgical means. The remaining 15 percent of the time bone marrow is collected through a surgical outpatient procedure that takes place at a hospital under general or regional anesthesia.

Individuals between the ages of 18 and 40 who meet the health eligibility criteria can join the Be The Match registry by visiting BeTheMatch.org, completing a health history form, and swabbing cheek cells with a home kit sent to the home of the registrant.

They also sponsor in-person swabbing events to encourage people to register as donors, and where potential registrants can be educated about the process.

More young people of diverse racial and ethnic heritage are needed to register to help patients in search of a match. People between the ages of 18 and 35 are most requested by transplant doctors, because this age group is shown to have the most potential for successful transplantation.

More importantly, anyone thinking of registering for Be The Match should seriously think about their commitment to the process before registering. There is no legal obligation for a registrant to participate but a last-minute decision not to donate could be life-threatening for a patient.

Less than 50 percent of registrants are able or willing to donate when asked.

There are two struggles with having enough Black donors: actually getting enough to register, and then when theyve been matched to a patient, having them follow through with the donation process, said Jensen. Well contact someone and say theyre a match for a patient in need and they will either ghost us or refuse to follow saying they dont have time, or dont like needles.

Donors should be willing to donate to anyone when asked because donations to specific patients are not allowed. All searches of the registry are anonymous, and donor and recipient patients may consent to exchange information one to two years after donation.

Stallworth has pounded the pavement getting people in her area to sponsor swabbing events.

Ive placed fliers all over, even on dumpsters to get people to sign up and to get businesses to sponsor swabbing events or allow them to take place on their premises, said Stallworth. Even if no match is made for me, I dont want anyone to have to wait like Im waiting.

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Black donors: we want you to 'be the match' - Afro American

Westford, USA, Aug. 18, 2022 (GLOBE NEWSWIRE) -- Multiple myeloma is a cancer of plasma cells in the bone marrow. It is the most common type of leukemia, and the fifth most common cancer around the globe. Prevalence rates of multiple myeloma have more than doubled over the past 30 years and continue to increase, reaching an all-time high of 1.3 million people in 2021. As per SkyQuest analysis of the Multiple Myeloma market, the global prevalence of multiple myeloma is currently pegged at 0.7%, which translates to around 1 case in 132 individuals. However, the rate varies as per country, region, gender, and external conditions. For instance, in the US alone more than 34,470 Americans are expected to be diagnosed with the diseases and men are expected to be more prevalent than men in 2022.

Multiple myeloma can be diagnosed at any age, but most cases are diagnosed in elderly adults (over 60 years old). The risk factors for developing multiple myeloma include being a smoker, having a family history of the disease, and being overweight or obese. There is no one cure for multiple myeloma, but aggressive treatment with chemotherapy and/or radiation can result in remission or long-term survival in the global Multiple Myeloma market. Patients are advised to undergo regular blood tests to monitor their tumor status.

The majority of MM patients don't have a cure, almost 50%, and 100% will relapse post-treatment. It's important to find new therapies that will help these patients and improve their quality of life.

Get sample copy of this report:

https://skyquestt.com/sample-request/multiple-myeloma-market

Autologous Hematopoietic Stem Cell Transplantation to Become Popular Treatment option in Multiple Myeloma market

As per SkyQuest analysis, the treatment options available for MM are generally based on the stage of the disease. Stages I and II are treated with chemoradiation therapy, which may include alternating doses of radiation and chemotherapy, while stage III and IV are treated with chemo and immunotherapy. Our analysts believe that new multiple myeloma therapies will become available over the next few years, which could change the way MM is treated.

It is expected that multiple myeloma therapies using autologous hematopoietic stem cell transplantation (HSCT) will become more popular by 2025 in the global Multiple Myeloma market. There are several reasons for this trend: first, autologous HSC transplantation has been shown to be effective in treating MM when other treatments have failed; second, alternative therapies such as targeted therapy and monoclonal antibody drugs have not been as successful as chemo/radiation combinations; and third, HSCT is relatively affordable compared to other treatment options.

Stem cell transplants are controversial because they can be dangerous and often require lengthy rehabilitation. However, recent studies have shown that autologous hematopoietic stem cell transplantation (aHSC transplant) is becoming a more popular treatment option in multiple myeloma. aHSC transplants are reservoir cells from someones own blood, which can be used to treat many types of cancer.

aHSC transplants are safer than bone marrow transplants because they do not require donors who are specifically matched for the recipient. In addition, aHSC transplants only require fractional doses of radiation and chemotherapy, which make them less likely to cause side effects.

SkyQuest published a report on Multiple Myeloma market that covers a detailed insights about available treatment options for treating the condition. We have identified available treatment, their impact on patient health, affordability by pricing analysis and location. The also provides in-depth understanding about market analysis, trends, challenges, threat, and opportunities for the market participants.

Browse summary of the report and Complete Table of Contents (ToC):

https://skyquestt.com/report/multiple-myeloma-market

Recent Developments in Multiple Myeloma Market

SkyQuest Analysis of Ongoing Research in Global Multiple Myeloma Market

Multiple myeloma, an incurable cancer of the bone marrow, is a leading cause of death in adults. Despite advances in treatment over the years, there remains no cure for multiple myeloma. However, researchers are working on developing new and more effective treatments that can help improve the outlook for those living with multiple myeloma. Currently, more than 670 clinical trials are undergoing across the globe for the finding the treatment for multiple myeloma. Most of these studies are focused on testing efficacy and efficiency of the drugs for improving the treatment outcome of the condition.

The following are some of the ongoing research efforts being conducted to find new and better ways of treatment in global Multiple Myeloma market:

SkyQuest has analyzed all these ongoing clinical trials in the global Multiple Myeloma market in order to understand their impact on the global exosomes market. The report provides complete data on upcoming drugs, number of trials completed, which companies are likely to get affected by the launch of new drugs, how on-going clinical trials are expected to leave impact on overall market analysis, market revenue, and forecast. To get a detailed understanding of the clinical study on the global Multiple Myeloma market,

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Key Players in the Global Multiple Myeloma Market

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Global Cognition Supplements Market

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Global Multiple Myeloma Market to Hit Sales of $34.89 Billion By 2028 - GlobeNewswire

Generation of CD31+ endothelial cells derived from hiPSCs and their in vitro characterization

Several previous studies reported successful generation of ECs from hiPSCs (hiPSC-ECs) using a combination of small molecules, including a GSK3 inhibitor22. Based on previous reports, we generated hiPSC-ECs from hiPSCs using the GSK3 inhibitor CHIR99021 (Supplementary materials and methods, Supplementary Fig. 1a). To produce hiPSC-ECs expressing green fluorescence protein (GFP) to facilitate cell tracking in the heart tissues in further experiments, we produced hiPSCs expressing GFP signals by transfecting GFP lentiviral particles, enriched them by FACS based on GFP expression, and used them to differentiate into ECs (Supplementary Fig. 1b). qRT-PCR results verified that the expression level of OCT4, a pluripotency marker, was significantly reduced, and the expression level of CD31, a specific marker for EC, was significantly increased in the hiPSCs differentiating into the EC lineage (Supplementary Fig. 1c, Supplementary Table 1). On differentiation Day 7, we observed that approximately 25.08% of the differentiating hiPSC-ECs were positive for human CD31 antibody, and subsequently, we enriched these CD31+ cells by FACS. Following FACS, the enriched CD31+ hiPSC-ECs were maintained in human endothelial serum-free medium with cytokines, including VEGF, to maintain their characteristics as EC lineage cells (Supplementary Fig. 1c). The CD31+ hiPSC-ECs displayed a typical cobblestone-like EC morphology and expressed similar mRNA levels of EC-specific markers, such as cluster of differentiation 31 (CD31), vascular endothelial cadherin (VE-Cadherin), Von Willebrand factor (vWF) and vascular endothelial growth factor receptor 2 (VEGFR2), compared with human umbilical cord endothelial cells (HUVECs) (Supplementary Fig. 1c, d). The results from flow cytometry analysis further demonstrated that the CD31+ hiPSC-ECs were 97.19% and 85.53% positive for CD31 and CD144, respectively (Supplementary Fig. 1e). In addition, the immunofluorescence results confirmed that the CD31+ hiPSC-ECs expressed abundant levels of the CD31 and vWF proteins (Supplementary Fig. 1f). At the functional level, the CD31+ hiPSC-ECs displayed the capacity for uptake of Ac-LDL (Supplementary Fig. 1g) and the formation of a capillary-like network on top of Matrigel (Supplementary Fig. 1h).

To determine if the CD31+ hiPSC-ECs (hiPSC-ECs afterward) could form de novo vessels via a vasculogenesis-dependent mechanism in MI-induced hearts, we intramyocardially injected hiPSC-ECs at two different sites in the border zone of the MI-induced rat hearts. MI was generated by ligation of the left anterior descending (LAD) artery in the heart. hiPSC-ECs continuously expressing the green fluorescence (GFP) signal were used for tracking purposes. To visualize the functional vessels in the MI-induced hearts, we performed perfusion staining with isolection-B4 (IB4) conjugated with a red fluorescent dye, rhodamine, into the heart prior to tissue harvest 8 weeks after injection with hiPSC-ECs. Fluorescent image analyses showed that the number of IB4+ capillaries in the hiPSC-EC-injected hearts was significantly higher than that in the MI control hearts (Fig. 1a).

a Representative images of blood vessels stained with IB4-rhodamine (red) in the infarct zone, border zone, and remote zone and at 8 weeks after injection of hiPSC-ECs and their quantification summary. For quantification, the number of capillaries in five randomly selected fields (mm2) in each heart was counted. n=5. *p<0.05. Scale bars: 100m. b Representative image of blood vessels newly formed by iPSC-ECs-GFP (green), IB4-rhodamine (red) and DAPI (blue). Scale bars: 20m. cj Rats undergoing MI were intramyocardially injected with hiPSC-ECs or control cells, followed by echocardiography analysis. c The schematic timeline from MI modeling and transplantation of iPSC-EC to measurement of cardiac function. d Left ventricular ejection fraction (EF), (e) left fractional shortening (FS), (f) left ventricular internal diastolic dimension (LVIDd), (g) left ventricular internal systolic dimension (LVIDs), (h) septal wall thickness (SWT), (i) posterior wall thickness (PWT), and (j) relative wall thickness (RWT). n=6. *p<0.05. k Representative images showing cardiac fibrosis after staining with Massons trichrome in the hearts harvested 8 weeks after cell treatment. Quantification results of cardiac fibrosis (l) and viable myocardium (m). n=5. *p<0.05. Scale bars: 2000m.

Next, to evaluate the potential and magnitude of the contribution of hiPSC-ECs to vasculogenesis in the MI hearts, we traced the GFP and RFP signals from hiPSC-ECs within cardiac tissues. Confocal microscopy images demonstrated a considerable number of vessels, double-positive for both IB4 and GFP signals from hiPSC-ECs, in the infarct region of the heart tissues receiving hiPSC-ECs at 8 weeks post-injection. Interestingly, a substantial number of hiPSC-ECs were incorporated into the host capillary network, and many of them were located in the perivascular area (Fig. 1b). The results clearly suggest that hiPSC-ECs could reconstruct de novo vessels in ischemic hearts.

Given that vascular regeneration improved through vasculogenesis leads to functional recovery from MI, we hypothesized that intramyocardial injection of hiPSC-ECs into MI hearts may promote cardiac function. Subsequently, we performed serial echocardiography to evaluate left ventricular (LV) function and cardiac remodeling from PRE (1-week post-MI and prior to cell treatment), and 2, 4, and 8 weeks after cell treatment. In this study, we employed a MI model that cells were transplanted one week after induction of MI to mimic the clinical situation of MI patients as close as possible. The results of echocardiography demonstrated that both ejection fraction (EF) and fractional shortening (FS) in all experimental groups were significantly lower compared with the sham group that did not receive any intervention. (Supplementary Fig. 2ag). Of importance, the hearts receiving hiPSC-ECs displayed significantly higher EF and FS than those in the MI control group until 8 weeks after the cell treatment (Fig. 1cd). Among several parameters for cardiac remodeling, such as left ventricular internal diastolic dimension (LVIDd), left ventricular internal systolic dimension (LVISd), septal wall thickness (SWT), posterior wall thickness (PWT), and relative wall thickness (RWT), the LVIDd and LVIDs in the hiPSC-EC-treated hearts were significantly lower than those in MI control hearts, indicating that hiPSC-ECs protected the hearts from adverse cardiac remodeling. (Fig. 1ei and Supplementary Fig. 2h). Similarly, the results of Massons trichrome staining obtained using cardiac tissue harvested at 8 weeks post-cell treatment showed that the area of fibrosis (%) in the hiPSC-EC-injected group was considerably smaller and the viable myocardium (%) was larger than that in the MI control group (Fig. 1jm). Based on these results, we confirmed that hiPSC-ECs can directly contribute to de novo vessel formation in vivo in MI-exposed hearts, resulting in enhanced cardiac function.

Subsequently, we investigated our central hypothesis of whether simultaneous induction of both vasculogenesis and angiogenesis could lead to comprehensive vascular regeneration and functional improvement in the MIhearts. Since we already verified that hiPSC-ECs successfully achieved vasculogenesis in the MI hearts, we sought to identify an additional cellular source that can induce complementary angiogenesis from the blood vessels in the host heart and finally decided to test genetically modified human mesenchymal stem cells engineered to continuously release human SDF-1 protein (SDF-eMSCs)23. The SDF-eMSCs were indistinguishable from normal BM-MSCs. The SDF-eMSCs exhibited a homogeneous spindle-shaped cell morphology, representing hMSCs (Supplementary materials and methods, Supplementary Fig. 3a). The SDF-eMSCs had a high proliferative potential based on the gradual increase in population doubling levels (PDL) during the culture times compared to normal BM-MSCs24 (Supplementary Fig. 3b). The SDF-eMSCs expressed several markers specific for human MSCs, such as CD90, CD44, CD105 and CD73, without the expression of CD34, CD11b, CD19, CD45 and HLA-DR (Supplementary Fig. 3c). The SDF-eMSCs stably secreted human SDF-1 protein, as determined by human SDF-1 enzyme-linked immunosorbent assay (ELISA) analysis (Supplementary Fig. 3d). The results from SDF-eMSC karyotyping revealed a normal human karyotype of the SDF-eMSCs without chromosomal abnormalities, suggesting the genetic stability of the SDF-eMSCs (Supplementary Fig. 3e).

To investigate whether SDF-eMSCs could augment the angiogenic potential of ECs, we performed various types of in vitro experimental analyses with SDF-eMSCs. Among the first, to determine whether SDF-eMSCs influenced the gene expression associated with ECs and angiogenic properties, we treated 30% conditioned media (CM) harvested from cultured SDF-eMSCs or BM-MSCs to the cultured hiPSC-ECs for 3 days and performed qRT-PCR analyses. The expression levels of stromal-derived factor-1 alpha (SDF-1), tyrosine kinase with Ig and epidermal growth factor homology domain 2 (Tie-2), vWF, E-selectin (CD62), and intercellular adhesion molecule-1 (ICAM-1) were significantly higher in the hiPSC-ECs treated with SDF-eMSC-CM than in the hiPSC-ECs exposed to BM-MSC-CM (Fig. 2a). In particular, the increased expression of E-selectin and ICAM-1 is known to be involved in angiogenesis in the presence of activated ECs25,26,27,28,29. Next, in EC migration assays, as shown in Fig. 2, the addition of conditioned media from the SDF-eMSCs (SDF-eMSC-CM) significantly enhanced the migration of hiPSC-ECs or HUVECs compared with the migration of the ECs treated with CM from human bone marrow-derived MSCs (BM-MSC-CM), suggesting that cytokines released from the SDF-eMSCs bolster the mobility of ECs (Fig. 2b and Supplementary Fig. 4a). In addition, to test whether SDF-eMSCs directly promote the angiogenic potential of ECs, we performed Matrigel tube formation assays, a representative experiment to evaluate the vessel formation potential of cells. The results from Matrigel tube formation assays demonstrated that the number of branches formed in both the hiPSC-ECs and the HUVECs treated with 30% CM harvested from the cultured SDF-eMSCs was significantly greater than that in the BM-MSC-CM-treated ECs (Fig. 2c and Supplementary Fig. 4b). Interestingly, treatment with SDF-eMSC-CM not only promoted tube formation by the hiPSC-ECs but also contributed to the maintenance of vessels formed from the hiPSC-ECs. Unlike the hiPSC-EC-generated vessels exposed to BM-MSC-CM that began to disrupt the vessel structure within 24h of vessel formation, treatment with SDF-eMSC-CM supported the integrity of vessels for up to 48h.

a qRT-PCR analysis of relative mRNA expression associated with ECs and angiogenesis in the hiPSC-ECs treated with the conditioned media (CM) from cultured bone marrow mesenchymal stem cells (BM-MSC-CM) or SDF engineered MSCs (SDF-eMSC-CM) for 3 days. The y-axis represents the relative mRNA expression of target genes to glyceraldehyde-3-phosphate dehydrogenase (GAPDH). n=3. *p<0.05. b EC migration assay. Representative images of migrated hiPSC-ECs and quantification of the migrated area (%). The hiPSC-ECs were placed in transwells (top), and regular media (EGM, EBM) or the conditioned media (CM) collected from different cell sources (BM-MSC-CM and SDF-eMSC-CM) were placed in transwells (bottom) for 7h. n=3. *p<0.05. c Tube formation assay. The hiPSC-ECs were cultured in 24-well plates coated with Geltrex with regular media (EGM, EBM) or conditioned media (CM) (BM-MSC-CM and SDF-eMSC-CM) for 9, 24, or 48h. Representative images of tube formation and quantification summary for the number of junctions. n=3. *p<0.05.

To provide a cellular reservoir where SDF-eMSC-PAs can constantly release SDF-1 to MI hearts, we produced a patch encapsulating SDF-eMSC (SDF-eMSC-PA) by mixing SDF-eMSCs with a 2% heart-derived decellularized extracellular matrix (hdECM)-based bioink and loaded it onto the polycaprolactone (PCL) mesh (Fig. 3 and Supplementary Fig. 5). Subsequently, to confirm whether SDF-eMSC-PAs are functional and can efficiently release SDF-1, we cultured SDF-eMSC-PAs in vitro for 28 days (Supplementary Fig. 5a) and collected supernatants at various time points for three days to generate the release kinetics of the SDF1-eMSC-PAs using the SDF-1 ELISA kit. The cumulative release curve showed that although the initial concentration of SDF-1 was higher in the SDF-cytokine-PAs (300ng/ml) than in the SDF-eMSC-PAs on Day 0, no SDF-1 was detectable in the SDF-cytokine-PAs from Day 7. However, the expression of SDF-1 released from the SDF-eMSC-PAs increased consistently until Day 21 (Supplementary Fig. 5b), suggesting that SDF-eMSCs continuously secreted SDF-1 within the patch.

a Procedures for manufacturing a cardiac patch encapsulating SDF-engineered MSCs (SDF-eMSC-PA) with a polycaprolactone (PCL) platform produced by a 3D printing system. b Optical image within the hdECM patch. SDF-eMSC-PAs were prelabeled with the red florescence dye DiI for tracing. Scale bars: 1mm. c Image of epicardially transplanted SDF-eMSC-PAs in the MI-induced heart. d Macroscopic view of hearts at 8 weeks after PA transplantation.

To finally determine whether simultaneous induction of both vasculogenesis and angiogenesis by using hiPSC-ECs and SDF-eMSC-PAs could lead to comprehensive vascular regeneration and functional improvement in MI-induced hearts, we induced MI by LAD ligation after the formation of five experimental groups as follows: (1) MI control, (2) SDF-eMSC-PA implanted epicardium of MI hearts (PA only, 1106), (3) hiPSC-ECs, intramyocardial injection (EC only, 1106), and (4) combined platform of hiPSC-ECs and SDF-eMSC-PA (EC+PA, 1106 in each) (Fig. 4). We first performed serial echocardiography for all experimental groups at pre, 2, 4 and 8 weeks after cell treatment. All experimental groups were significantly reduced compared with that in the sham group (Supplementary Fig. 6ag). Of interest, cardiac function in the EC+PA group was significantly preserved until 8 weeks compared with its cardiac function at pre, but cardiac function in other groups, such as the control, hiPSC-EC alone and SDF-eMSC-PA alone groups, continuously decreased until 8 weeks. (Fig. 4ad). Adverse cardiac remodeling determined by the LVIDd, LVIDs, SWT, PWT, and RWT was notably reduced in the EC+PA group compared with the other groups (Fig. 4ei and Supplementary Fig. 6h). To further evaluate cardiac function more precisely, we performed LV hemodynamic measurements using an invasive pressure-volume (PV) catheter, which can measure the hemodynamic pressure and volume of the LV. The results of the PV loop at 8 weeks post-cell treatment showed that the EC+PA group had significantly improved cardiac function and prevented adverse cardiac remodeling compared with the other groups (Fig. 5). The two parameters of general cardiac function, stroke volume (SV) and cardiac output (CO), were significantly higher (Fig. 5ac), and the maximum volume (V max), which is the cardiac remodeling index measured at the maximum diastole, was significantly lower in the EC+PA group than in the other groups (Fig. 5d). Although the pressure max (P max) measured at the maximum systole did not differ significantly between groups, the maximum rate of pressure change (dP/dtmax) and the minimum rate of pressure change (dP/dtmin), which indicate the pressure change in LV per second, were increased in the EC+PA group. (Fig. 5ef and Supplementary Fig. 7a). Temporal variation in the occluded inferior vena cava (IVC) was used to evaluate load-independent intrinsic cardiac contractibility. The end-diastolic pressure-volume relationship (EDPVR), which indicates the absence of diastolic dysfunction, did not differ between the groups, whereas the slope of the end-systolic pressure volume relationship (ESPVR), which indicates cardiac contractibility, was significantly improved in the EC+PA group compared with the other groups (Fig. 5gh and Supplementary Fig. 7b). Collectively, these results from LV hemodynamic measurements consistently demonstrate that treatment with the combined platform with hiPSC-ECs and SDF-eMSC-PAs improves cardiac repair in MI hearts.

a Left ventricular ejection fraction (EF). b EF delta change at 8 weeks after cell treatment. c Left fractional shortening (FS). d FS delta change at 8 weeks after cell treatment. e Left ventricular internal diastolic dimension (LVIDd). f Left ventricular internal systolic dimension (LVIDs). g Septal wall thickness (SWT). h Posterior wall thickness (PWT). i Relative wall thickness (RWT). n=611. *p<0.05.

a Representative images of the hemodynamic pressure and volume (PV) curve at steady state at 8 weeks post-cell treatment. b Stroke volume (SV). c Cardiac output (CO). d Volume max (V max) defining the amount of blood volume in the LV at end-diastole. e dP/dtmax refers to the maximal rate of pressure changes during systole. f The minimal rate of pressure changes during diastole (dP/dtmin). g Slope of end-systolic pressure volume relationship (ESPVR) indicating the intrinsic cardiac contractibility as measured by transient inferior vena cava (IVC) occlusion. h Slope of end-diastolic pressure volume relationship (EDPVR). n=4. *p<0.05.

Next, we investigated the in vivo behavior of intramyocardially implanted hiPSC-ECs in the presence or absence of SDF-eMSC-PAs. Since hiPSC-ECs constantly express GFP, we could track their fate in heart tissue sections. Confocal microscopic examination of heart tissues harvested at 8 weeks after cell treatment demonstrated that implantation of SDF-eMSC-PAs significantly improved the retention and engraftment of intramyocardially injected GFP-positive hiPSC-ECs. Quantitatively, the proportion of GFP-positive hiPSC-ECs in the EC+PA group was substantially higher than that in the EC group (Fig. 6a). Of interest, while the hiPSC-ECs in the hiPSC-ECs alone group were localized near the injection sites, the hiPSC-ECs in the EC+PA group were distributed throughout the regions of the left ventricle. Given the ability of SDF-eMSC-PAs to improve the survival and retention of injected hiPSC-ECs, we sought to examine whether SDF-eMSC-PAs exerted direct cytoprotective effects in hiPSC-ECs in vitro. Ischemic injury was simulated by exposing hiPSC-ECs to H2O2 (500M). Administration of CM from SDF-eMSCs (SDF-eMSC-CM) significantly improved the viability of both hiPSC-ECs and HUVECs as determined by the LIVE/DEAD assay and CCK-8 assay (Supplementary Fig. 8af). Treatment with SDF-eMSC-CM substantially increased the number of viable cells, suggesting that SDF-eMSC-CM exerts direct cytoprotective effects on ECs against ischemic insults. Subsequently, we performed thorough histological analyses using heart tissues harvested 8 weeks post-cell treatment to examine whether SDF-eMSC-PAs could concurrently promote hPSC-EC-dependent vasculogenesis as well as angiogenesis of host blood vessels. IB4 conjugated with rhodamine was systemically injected to identify the functional endothelium in these experiments. Initially, confocal images demonstrated that the number of total IB4-positive (IB4+) capillaries in both the border zone and infarct zone of the hearts in the EC+PA group was substantially higher than that in the other groups, including the EC group (Fig. 6b). The number of vessels that were GFP negative but positive for IB4 (GFP-/IB4+) was also significantly higher than that in other groups, including the EC-only group (Fig. 6c). These results suggest that the combined approach significantly promoted the angiogenesis of host vessels in MI hearts. More importantly, the number of de novo vessels formed by hiPSC-ECs-GFP+ was substantially higher in the EC+PA group than in the EC-only group, indicating that SDF-eMSC-PAs facilitates hiPSC-EC-dependent vasculogenesis (Fig. 6de and Supplementary Fig. 9a). Notably, the number of larger blood vessels (diameter range: >5 m), one of the indicators of functional blood vessels in the EC+PA group, was significantly higher than that in the EC group. Of interest, many of those larger vessels in the EC+PA group displayed abundant expression of -SMA, a marker for smooth muscle cells, suggesting that these larger vessels (CD31+/-SMA+) may be arteriole-like vessels, indicating that SDF-eMSC-PA played certain roles in vascular ingrowth and maturation (Fig. 6eg and Supplementary Fig. 9b).

a Representative image of hiPSC-ECs-GFP within the infarct area at 8 weeks post-cell treatment and their quantification summary. n=3. *p<0.05. Scale bars: 1000m. b Representative images of blood vessels stained with IB4-rhodamine (red) in the infarct zone (IZ), border zone (BZ), and remote zone at 8 weeks after cell treatment and a summary of their quantification. n=57. *p<0.05. Scale bars: 100m. c Representative images of blood vessels negative for GFP but positive for IB4 (GFP-/IB4+) in the infarcted area and their quantification summary. hiPSC-ECs-GFP (green), IB4-rhodamine (red) and DAPI (blue). n=5. *p<0.05. Scale bars: 20m. d, e Representative images of GFP and IB4 (GFP+/IB4+)-positive blood vessels in the infarcted area and their quantification. hiPSC-ECs-GFP (green), IB4-rhodamine (red) and DAPI (blue). n=5. *p<0.05. Scale bars: 20m. f, g Diameter of hiPSC-EC-derived GFP-positive blood vessels in the infarcted area and border zone. n=5. *p<0.05.

To further investigate whether the vascular regeneration achieved by the combined platform (EC+PA) was sufficient to salvage the myocardium from ischemic insult, we quantified the viable myocardium by immunostaining for cardiac troponin T (cTnT) antibody using the heart tissues harvested from all experimental groups at 8 weeks post-cell treatment. The number of viable cTnT+ cardiomyocytes in the EC+PA group was significantly higher than that in the other groups (Fig. 7a). These results from histological analyses using heart tissues motivated us to test whether SDF-eMSCs (Supplementary Fig. 10a) could confer direct cytoprotective effects on cardiomyocytes against ischemic insults in vitro. Ischemic injury was simulated by exposing cardiomyocytes to H2O2 (500M). The results from both the LIVE/DEAD assay and the cholecystokinin-8 (CCK-8) assay demonstrated that the administration of SDF-eMSC-conditioned media (CM) significantly improved the viability of cultured cardiomyocytes isolated from neonatal rats (NRCM) against H2O2 treatment compared with other treatments. These results also suggest that SDF-eMSCs have direct cytoprotective effects against ischemic insults (Supplementary Fig. 11ac).

a Representative immunostaining images of myocardium stained with cTnT (green) and DAPI (blue) at 8 weeks after cell treatment and quantification of the number of cTnT-positive cardiomyocytes. SDF-eMSCs labeled with DiI within the cardiac patch (red) n=5. *p<0.05. Scale bar: 300m. b Representative images of Massons trichrome staining using heart tissues harvested 8 weeks after cell treatment. c, d Quantification summary of a percentage of fibrosis and viable myocardium. n=5. *p<0.05. Scale bars: 2000m.

Consequently, the combined treatment group showed a significant decrease in cardiac fibrosis. The results of Massons trichrome staining using cardiac tissue harvested at 8 weeks exhibited an area of fibrosis (%), which was significantly lower in the combined treatment groups than in the other groups (Fig. 7bd). Taken together, our results clearly suggested that the combined treatment resulted in comprehensive cardiac repair through enhanced vascular regeneration and that the SDF-eMSCs contributed at least to some extent indirect protection of myocardium from ischemic injury via consistent secretion of cytoprotective SDF cytokines.

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Enhancement strategy for effective vascular regeneration following myocardial infarction through a dual stem cell approach | Experimental &...

In 2009, I was living in Buckinghamshire, England with my husband. We had a two-year-old and a four-year-old and I had just stopped working for a big bank, so I had no private health insurance.

Around that time, I'd been getting these sore throats, totally out of the blue. They were wiping me out for a week at a time, which with two young kids was pretty difficult. I started to get them almost on a monthly basis. And so I decided I was going to get myself checked, just in case. But I didn't expect anything really.

It never crossed my mind that I would be diagnosed with anything serious. When I went into the doctor's surgery in May, the nurse did a throat swab and actually wasn't going to bother doing a blood test. I remember she then said, "Let's just do a blood test now."

My family and I then went on vacation with friends, but when we came back, I had a message from my doctor saying she wanted to talk to me about the blood tests. So I went in for an appointment, and she told me that the hospital had picked something up and wanted to run some more tests. But she genuinely didn't seem to believe that it was going to be anything serious.

At that stage, I was obviously a bit worried. But I thought of how you hear these situations where people go in and get tested and everything's fine. I thought I'd be a little bit nervous, but that it would all probably be OK and that perhaps I was just being a drama queen.

But when I got to the hospital elevator, I saw that I had been directed to a hematology department and cancer unit and I just burst into tears.

My husband and I then went in and spoke to a consultant and he explained that after seeing this one blood test, they wanted to do some more tests. They wanted to rule out multiple myeloma, a type of bone marrow cancer. But they reassured me that typically it was diagnosed people over 70 and more common in men and within the Black population. I was told that at the age of 34, I was likely far too young to have it.

The first tests all came back and looked OK; my bloods weren't as bad as I thought. I had no bone damage and the X rays were all clear. Then I had a bone marrow biopsy and the doctor came back and told me that I had 10 percent cancerous myeloma cells (abnormal plasma cells) in my bones. So I got diagnosed with myeloma less than six weeks after I first went to the doctor. I was classed as having smoldering multiple myeloma (SMM) for the first year, an earlier disease stage of multiple myeloma where the abnormal plasma cell levels in my bones and paraprotein levels in my blood weren't quite bad enough for any action to be taken immediately. Even being diagnosed with smoldering multiple myeloma is quite rare.

I still don't know if my sore throats were related to my diagnosis, but there is research that indicates some people with SMM can have impaired immune systems, because myeloma affects plasma cells, which are part of the immune system. So perhaps I was more vulnerable to picking up illnesses at that time.

I think a lot of doctors don't give a specific prognosis. If I'd asked direct questions, I think they would have talked to me about it. But I didn't really do that. I think I didn't really want to know.

But the general prognosis I saw everywhere in those days for myeloma was around two to five years. It felt like my whole world just fell away overnight really. I genuinely didn't believe I was going get to see my kids get through elementary school, let alone high school.

My myeloma became more active in 2010. I had more than 10 percent cancerous cells in my bone marrow, which rose to 50 percent at worst, my calcium levels had risen, I was borderline anemic and I was suffering from some bone pain. So, the same year I joined the Myeloma XI trial. It involved maintenance therapy with a cancer drug called lenalidomide. The trial started with chemotherapy, then a stem cell transplant and then the maintenance therapy drug.

I went through two different types of chemotherapy and then had my first stem cell transplant in 2011. I was really worried still at this stage, fearing that because my condition had progressed, the prognosis of living for two to five years might be accurate.

The stem cell transplant was one of the worst experiences of my life. I was just so sick. I felt like I wanted the world to swallow me up. During the treatment your stem cells are collected, then you have a high dose of chemotherapy before the stem cell transplant takes place. I got ulcers in my mouth, couldn't eat and had no energy. When my husband visited I would just be asleep. I couldn't talk to him. I couldn't talk to anyone. I didn't see my children for three weeks. They came into the hospital once and it was just so difficult that I told my husband not to bring them again.

The first stem cell transplant put me into a partial remission. I was lucky that that was on the trial from 2011 till 2019, because that maintenance therapy wasn't available to most people at that time. Partial remission allowed my life to return to almost normal. Whilst I still had to be careful to avoid infections, I was able to go back to working, I took up netball for the first time since school, and focused on fundraising. Most importantly, I was there for my family.

But by 2019, my paraprotein levels had been going up for a year or so and they went outside of the trial guidelines. So doctors had to take me off the maintenance therapy, which meant those levels increased at a faster rate. I went back onto a different type of chemotherapy and immunotherapy, and then had another stem cell transplant in 2020. Now I'm on immunotherapy.

I think the maintenance therapy was a game changer because it gave me a much longer remission than a lot of people get, though treatments are getting better all the time, and now there are more options. When I do relapse again, which I will, hopefully there will be more options for me.

I hope that I can live with multiple myeloma long term. We're also keeping our fingers crossed for a cure at some stage.

If the nurse hadn't done those blood tests in 2009, it might have been months or years before I'd been diagnosed. And who knows whether that would have been good, in a way, because I'd have lived a few years without knowing, or whether I'd have ended up with bone damage or kidney damage, which is how lots of people get diagnosed with myeloma, when things have gone too far. But over the years I've realized there's nothing to be gained by having that conversation with myself. So I don't have it anymore.

I am hopeful for the future. I've become much more positive about my diagnosis. I began fundraising for the charity Myeloma UK, which has really been my savior because it's allowed me to have a focus on something that feels really positive. And, I now work as a community fundraiser for the charity Brain Tumour Research, and I love my job. It's the first time I've ever loved a job.

So I'm going to hope for the best, and if I relapse then we'll deal with that at the time.

Deb Gascoyne lives in the U.K. with her husband and two children.

All views expressed in this article are the author's own.

As told to Jenny Haward.

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'I Had a Sore Throat, Weeks Later I Was Diagnosed with a Rare Disease' - Newsweek

A London mum has lost nearly three inches in height after being diagnosed with an aggressive form of blood cancer. Antoinette Carr, 49, had just returned to work as a Projects Administrator after the birth of her second child when she felt extremely tired.

She assumed that it was simply the result of being a mum to two young children, but it turned out to be multiple Myeloma. The mum from Enfield visited her GP initially thinking her symptoms might be down to a vitamin deficiency and so the shock of the diagnosis caused an "out-of-body experience" and she wasn't to know the diagnosis would result in a years-long ordeal and multiple fractures in her spine.

After a series of tests, Antoinette was diagnosed with Multiple Myeloma, an incurable form of blood cancer in February 2012. She told MyLondon: "I just felt so tired. I thought it would be a vitamin deficiency or something, I never even considered it would be cancer. But when doctors said I needed a bone marrow biopsy, that's when the penny dropped."

Read more: 'Healthy, happy' nursery worker, 21, died with Covid-19 while waiting for liver transplant

"It almost felt like an out of body experience," she added. "It was like I was in the room, and I could see the doctor's mouth moving, but I couldn't actually hear or take in what he was saying to me."

Multiple myeloma, also known as myeloma, is a type of bone marrow cancer. Bone marrow is the spongy tissue at the centre of some bones that produces the body's blood cells . In the early stages, it often doesn't cause any symptoms and is only diagnosed after a routine blood or urine test. Eventually, it may show up with a persistent bone pain and tiredness.

To confirm the diagnosis, Antoinette had to endure a bone marrow biopsy to test how much myeloma is in the blood. Antoinette said doctors numbed the area of her back and took a long needle "like a skewer" and twisted it into her back "like a corkscrew".

"I felt it all," she said. "It was worse than childbirth. The pain was just horrendous.

"Even to this day I've had to have biopsies and every time the doctor says to me, 'we're going to have to do bone marrow biopsy'. I just broke down crying, begging for sedation."

Over the past 10 years, Antoinette has had eight different chemotherapy treatments including a autologous stem cell transplant all to varying degrees of success. She got used to visiting hospital regularly, often up to three times a week as her cancer went through periods of shrinking and growing.

But at its worst, just a week into the COVID-19 pandemic, the cancer cells had spread into Antoinettes spine, weakening it and this caused 13 separate spinal fractures and collapsed vertebrate's, leading to her losing three inches in height.

One day, she was washing her hair over the bath when she stood up and had a sharp pain in her back. Undeterred, she went into her bedroom to get the hairdryer out when she was unable to pick it up. Antoinette explained: "I called my husband. I went downstairs and sat down but then I couldn't move.

"On the way to the hospital I just kept throwing up in the car. By the time we got to the hospital, I was covered in it all and so embarrassed. Doctors then said I had four fractures in my back."

Antoinette had an operation and was given a back brace and told to rest up. However her pain got worse and eventually she was unable to even go to the toilet by herself without the help of her husband Richard.

Doctors believed she may have been given the wrong type of brace, which lead to her back being unsupported and the thirteen total fractures, which were inoperable. She now requires a walking stick.

"A few of the vertebrae had completely collapsed, they couldn't fix them," she explained. "So as a result, I've lost three inches in height. I know because the tap in the kitchen. I used to look down on it. Now the taps are basically in my face. I've got a shorter spine, I've essentially collapsed like a pack of cards.

"If I'm standing up and you look at me from the side, you can see me hunched forward as I've got like a curve in my back. I do try to stand up straight but it's quite painful. When I'm standing up straight and I'm walking, it feels like there's a magnet pulling me forward. So I use the walking stick to give me a more upright posture.

"And there's nothing more doctors can do about the hunch and as someone who's not old, it really does affect me. It took me ages to be able to look in the mirror and not cry."

Although Antoinettes future is determined by the results of her monthly blood tests, she is still determined to live the life that she has in full. Many treatment options have now been exhausted, but she was accepted into a clinical trial for a new experimental drug since November 2021. She has been responding well to the treatment so far, but the trial has been extremely tough on her, due to the many side effects.

Unfortunately a stem cell match has also yet to be found for Antoinette, but she remains hopeful even after all that she has been through. She added: "It's my kids and my husband that keep me going. This is why I keep fighting because I want to see them grow up. Every milestone is a blessing. I just couldn't imagine not being there for them."

Antoinette's best friend Jenesse has been fundraising to get her to Jamaica for her 50th birthday to see family. You can donate here. Jenesse also urges others to add themselves to get stem cell register in case they are a match for Antoinette, or another blood cancer patient.

Stem cells can grow into any other cell in your body and this means they can be used to treat a wide range of blood cancers and disorders. For some people, a stem cell transplant, which is also known as a bone marrow transplant, is the only hope of survival.

However, 65 to 75 per cent of those in need (about 400 UK patients) are unable to find a sibling match so rely on the generosity of strangers. Those interested as in registering as a donor must order a swab kit online which can be done on the Anthony Nolan website here.

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London mum loses 3 inches in height due to curved spine after devastating cancer diagnosis - My London

A bone marrow transplant is a medical procedure that replacesthe bone marrow with healthy cells. Replacement cells might come from either ones own body or from a donor. A stem cell transplant, or more specifically, a hematopoietic stem cell transplant, is another name for a bone marrow transplant. Transplantation can be used to treat leukemia, myeloma, and lymphoma, as well as other blood and immune system illnesses that impact the bone marrow. Cancer and cancer treatment can damage the hematopoietic stem cells. Hematopoietic stem cells are blood-forming stem cells. Hematopoietic stem cells that are damaged may not develop into red blood cells, white blood cells, or platelets. These blood cells are vital, and each one serves a specific purpose. A bone marrow transplant can help the body regenerate the red blood cells, white blood cells, and platelets it requires.

The global Bone Marrow Transplant market is estimated to be valued at $10,356.1 Mn Mn in 2021 and is expected to exhibit a CAGR of 4.0% over the forecast period (2022-2028).

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The study provides data on the most exact revenue estimates for the complete market and its segments to aid industry leaders and new participants in this market. The purpose of this study is to help stakeholders better understand the competitive landscape and design suitable go-to-market strategies. The market size, features, and growth of theBone Marrow Transplantindustry are segmented by type, application, and consumption area in this study. Furthermore, key sections of the GlobalBone Marrow Transplantmarket are evaluated based on their performance, such as cost of production, dispatch, application, volume of usage, and arrangement.

Competitive Analysis: Global Bone Marrow Transplant Market

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: United States, Canada, and Mexico & : Argentina, Chile, Brazil and Others & : Saudi Arabia, UAE, Israel, Turkey, Egypt, South Africa & Rest of MEA. : UK, France, Italy, Germany, Spain, BeNeLux, Russia, NORDIC Nations and Rest of Europe. -: India, China, Japan, South Korea, Indonesia, Thailand, Singapore, Australia and Rest of APAC.

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Company profiles, revenue sharing, and SWOT analyses of the major players in theBone Marrow TransplantMarket are also included in the research. TheBone Marrow Transplantindustry research offers a thorough examination of the key aspects that are changing, allowing you to stay ahead of the competition. These market measuring methods assist in the identification of market drivers, constraints, weaknesses, opportunities, and threats in the global market.

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Increasing efforts to set up centers for Bone Marrow Transplant is expected to Boost the growth of the market, Top Key players | Lonza, Merck KgaA,...

Are you age 18-40? Did you know thousands of people are waiting to find a lifesaving donor match for marrow or stem cells, many of them children?

Lord of New Life Lutheran Church of Midland is hosting a Be The Match donor registry drive at the Monday, Aug. 15 through Saturday, Aug. 20 at Midland County Fairgrounds. The drive will be 11 a.m.-10 p.m. Monday through Friday and 10 a.m.-8 p.m. Saturday at building 25, space 47.

Be The Match, operated by the National Marrow Donor Program, is a global leader in marrow/stem cell transplantation. They also host an international registry that matches patients who need a lifesaving transplant with eligible donors.

A marrow/stem cell donation is often the only cure for leukemia, lymphoma, sickle cell and other deadly diseases.

Matches are determined by genetic traits, not blood type, and can be difficult to find. Only 30% of patients have matches within their own family. Thousands of patients are waiting to find a match.

Many are not even aware of the program and that they can literally save someones life,said Jamie Fiste, drive organizer. If anyone is interested, we encourage them to stop by our booth. We will have everything they need to get placed on the registry. People can also register right from home.

If contacted by Be The Match, the organization arranges the entire donation process.

For more information about Be The Match, the donation process, or to register from home, visit http://www.bethematch.org.

For more information about the registry drive, visit http://www.lordofnewlife.org/be-the-match-bone-marrow-registry-drive.

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Save a life by joining Be The Match registry at Midland Fair - Midland Daily News

By UNC Health Talk

In the first few minutes after a baby is born, the babys umbilical cord (which carries oxygen and nutrients from the placenta to the growing fetus) is cut and usually discarded.

But many people dont realize that extracting and donating the nutrient-rich blood from the cord can save someone elses life, as it did for 1-year-old Cole Baranowski.

Thanks to a cord blood transplant, Cole is now in remission from leukemia. He received an umbilical cord blood unit after his unrelated adult donor fell through.

UNC Health pediatric hematologist-oncologist Kimberly Kasow, DO, who specializes in bone marrow transplantation, explains how umbilical cord blood donation works and how it can give critically ill patients a second chance at life.

Umbilical cord blood is the blood left in the umbilical cord and placenta after a baby is delivered. It is rich in young blood-making cells, called hematopoietic stem cells.

Most cells can only make copies of themselves; for example, a skin cell can only make another skin cell. However, hematopoietic stem cells can mature into different types of blood cells in the body that will grow up to support the immune system and blood function. These stem cells can be used to treat more than 70 different diseases, including blood and bone marrow cancers such as leukemia and lymphoma; other blood disorders, such as sickle cell disease; bone marrow failures such as aplastic anemia; and disorders of the immune system, such as severe combined immunodeficiency.

Many patients with one of these conditions will require a lifesaving blood or marrow transplant to replace the unhealthy blood-forming cells with healthy ones. (Bone marrow is the spongy tissue inside bones that contains stem cells that can develop into blood cells.)

As bone marrow transplant doctors, we will consider using umbilical cord blood for transplant because it is enriched in young cells that will grow and mature to be the healthy red and white blood cells and platelets that our patients need to survive, Dr. Kasow says.

When a patient needs a lifesaving blood or marrow transplant, umbilical cord blood is one of three sources that providers use, in addition to bone marrow and blood from adult donors. Cord blood may be a preferred option; it doesnt have to match the recipient as perfectly as a marrow or blood product from an adult donor should, since umbilical cord cells are not as mature. Cord blood transplant can be used in both children and adults.

Theres a lot to consider when selecting the right stem cell product and donor for our patients, Dr. Kasow says. We want the closest match possible to keep their body from rejecting these new cells and to prevent undesirable side effects. Oftentimes, these young cells in cord blood may help minimize those risks.

The Baranowskis experienced the benefits of a cord blood donation firsthand.

Cole had been scheduled to receive a bone marrow transplant from an adult donor, but when he was only a week from his scheduled transplant, the Baranowskis learned that his donor was not able to donate.

Cole had already been through two rounds of chemotherapy and CAR T-cell therapy (the process of training the patients own immune cells to destroy cancer cells) to get him healthy enough to receive the transplant.

To make matters worse, his parents had just learned that his cancer was starting to come back. Frantic to get him the healthy blood he needed, they felt they were back at square one. Thankfully, an umbilical cord blood match provided a quick solution.

The day we found out the donor fell through was as bad as the day we found out Cole had leukemia, says Allison Baranowski, Coles mom.

But were so thankful someone was so thoughtful and generous to donate their babys cord blood it saved Coles life. We didnt have to jump through as many hoops as if we had decided to pursue another adult donor.

Cole received his cord blood transplant March 4. His care team at the UNC Childrens decorated his room in a Batman theme and celebrated his second birthday his second chance at life.

Awareness about the ability to donate your babys umbilical cord blood is so important. Theres really no downside to it, and it can literally save a life, Baranowski says.

There are two ways to preserve umbilical cord blood:

Donate it to a public cord blood bank.

If you want to donate your babys cord blood, make sure your hospital is a collection site. For example, UNC Rex Hospital in Raleigh and N.C. Womens Hospital in Chapel Hill are collection sites for the Carolinas Cord Blood Bank, one of the largest and most respected cord blood banks in the world. Youll need to let your care team know that you want to donate before you go into labor.

If you choose to donate, youll be asked to provide your familys medical history, similar to when you donate blood as an adult. Your blood will be screened for genetic disorders and infections, per U.S. Food and Drug Administration guidelines. The babys umbilical cord blood will be tested to make sure it is healthy and has enough cells. If its viable, it will be frozen and listed in a registry, available for anyone in need of a transplant. Cord blood units that do not qualify can often be used for research, which is also important for future lifesaving discoveries.

Cord blood donations are an especially important option for ethnic minorities in need of a transplant, as it is usually harder for them to find adult donors who are a match when a sibling match is not an option.

Pay a third-party company to store it in a private cord blood bank to be used by the child or a family member later in life.

Some families choose to bank their childs umbilical cord blood privately, in the event that the child or another family member might need it in the future. If you choose to bank your childs cord blood, numerous vendors offer kits that you can purchase before delivery. Make sure you ask how much it will cost to collect and process the cord blood, and to store it annually.

Banking cord blood is a good option for parents who already know of a medical issue in the family that might require a blood or marrow transplant. For example, it might be recommended to a parent who already has a child with leukemia. However, theres no guarantee the childs cord blood will match the family members needs, Dr. Kasow says.

If you dont already have a family member in need of a blood transplant, chances are very small that you would need to use cord blood thats been banked privately, she says. And on the flip side, if you donate the cord blood to a public bank and find later that you need it for your child or a family member, your provider can check to see if it made it into the registry and if it is still available.

If you have questions about whether to donate or preserve your babys umbilical cord blood, talk to your doctor. For more information on cord blood preservation, visit BeTheMatch.org or the American College of Obstetricians and Gynecologists.

Editor's note: This story originally appeared on the UNC Health Talk blog.

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Umbilical cord blood donation saved 1-year-old boy's life - WRAL News

Cell membrane-coated nanoparticles, applied in targeted drug delivery strategies, combine the intrinsic advantages of synthetic nanoparticles and cell membranes. Although stem cell-based delivery systems were highlighted for their targeting capability in tumor therapy, inappropriate stem cells may promote tumor growth.

Study:Stem cell membrane-camouflaged targeted delivery system in tumor. Image Credit:pinkeyes/Shutterstock.com

A review published in the journalMaterials Today Biosummarized the role of stem cell membrane-camouflaged targeted delivery system in tumor therapy and focused on the underlying mechanisms of stem cell homing toward target tumors. Nanoparticle-coated stem cell membranes have enhanced targetability, biocompatibility, and drug loading capacity.

Furthermore, the clinical applications of induced pluripotent stem cells (iPSCs) and mesenchymal stem cells (MSCs) were investigated as membrane-camouflaged targeted delivery systems for their anti-tumor therapies. In concurrence, the stem cell membrane-coated nanoparticles have immense prospects in tumor therapy.

Cell-based targeted delivery systems have low immunogenicity and toxicity, innate targeting capability, ability to integrate receptors, and long circulation time. Cells such as red blood cells, platelets, stem cells, tumor cells, immune cells, and even viral/bacterial cells can serve as effective natural vesicles.

MSCs derived from the umbilical cord (UC-MSCs), bone marrow (BM-MSCs), and adipose tissue (ATMSCs) are utilized in clinical applications. However, iPSCs are preferable over MSCs in clinical applications due to their easy fetch by transcription factor-based reprogramming of differentiation of somatic cells.

Stem cells (MSCs/ iPSCs) can be easily isolated and used as drug delivery systems for tumor therapy. Stem cell-based delivery systems have inflammation or tumor lesions targeting capacity. However, stem cells are often entrapped in the lung due to their size, resulting in microembolism.

Cell membrane-coated nanoparticles are applied in targeted delivery strategies. To this end, stem cell membrane-coated nanoparticles have tremendous prospects in biomedical applications. Although previous reports mentioned the role of cell membrane-coated nanocarriers in tumor therapy, delivery systems based on stem cell membranes have not been explored extensively.

Stem cell membrane-coated nanoparticles obtained from stem cells have complex functioning and can achieve biological interfacing. Consequently, stem cell membrane-coated nanoparticles served as novel drug delivery systems that could effectively target the tumor.

Previous reports mentioned the preparation of doxorubicin (DOX) loaded, poly (lactic-co-glycolic acid) (PLGA) coated MSC membrane-based nanovesicles, which showed higher cellular uptake than their PLGA uncoated counterparts. Similarly, the DOX-loaded MSC membrane-coated gelatin nanogels showed enhanced storage stability and sustained drug release.

Thus, the stem cell membrane-coated nanoparticles served as novel carriers for stem cells and facilitated the targeted delivery of the drugs at the tumor site. Since the stem cell membrane-coated nanoparticles had good targeting and penetration abilities, they enhanced the efficiency of chemotherapeutic agents in tumor therapy and minimized the side effects.

Reactive oxygen species (ROS) based photodynamic therapy (PDT) is mediated by photosensitizers with laser irradiations. Previous reports mentioned the development of MSC membrane-based mesoporous silica up-conversion ([emailprotected]2) nanoparticles that efficiently targeted the tumor due to their high affinity after being coated with MSC membrane.

These cell membrane-coated nanoparticles showed high cytocompatibility (with hepatocyte cells) and hemocompatibility (with blood). Moreover, the [emailprotected]2 nanoparticles-based PDT therapy under 980-nanometer laser irradiations could inhibit the tumors in vivo and in vitro. Consequently, the stem cell membrane-coated nanoparticles had circulation for an extended time and escaped the immune system, thereby increasing their accumulation at the tumor site.

Stem cell membrane-coated nanoparticles were also applied to deliver small interfering RNA (siRNA) via magnetic hyperthermia therapy and imaging. Previous reports mentioned the preparation of superparamagnetic iron oxide (SPIO) nanoparticles using an MSC membrane that reduced the immune response.

Additionally, the CD44 adhesion receptors were preserved on the surface of the MSC membrane during preparation. These prepared nanovesicles were unrecognized by macrophages, which enabled their stability in blood circulation. The nanosize and tumor homing capacity of MSCs helped the nanovesicles generate a dark contrast in T2-weight magnetic resonance imaging (MRI).

Cell membrane-coated nanoparticles helped fabricate various targeted delivery strategies. Especially, stem cell membrane-coated nanoparticles have the following advantages: stem cells are easy to isolate and expand in vitro. Thus, multilineage potential and phenotypes could be preserved for more than 50 population doublings in vitro.

Stem cell membrane-coated nanoparticles also have an intrinsic capacity to target inflammation or tumor lesions. Hence, these nanoparticles were established for tumor therapy, building a strong foundation for stem cell membrane-mediated delivery systems.

On the other hand, stem cell membrane-coated nanoparticles have the following drawbacks: Despite various sources for collecting MSCs (UC-MSCs/BM-MSCs/ATMSCs), the number of cells obtained is limited, although iPSCs are relatively easy to fetch by reprogramming differentiated somatic cells, the reprogramming is a high-cost step, restricting the clinical applications of iPSCs.

Zhang, W., Huang, X. (2022). Stem cell membrane-camouflaged targeted delivery system in tumor. Materials Today Bio.https://www.sciencedirect.com/science/article/pii/S2590006422001752

Disclaimer: The views expressed here are those of the author expressed in their private capacity and do not necessarily represent the views of AZoM.com Limited T/A AZoNetwork the owner and operator of this website. This disclaimer forms part of the Terms and conditions of use of this website.

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Stem Cell Membrane-Coated Nanoparticles in Tumor Therapy - AZoNano

The publication of proposals for new European Union rules on the use of substances of human origin (SoHO) has elicited largely positive responses from industryso far. But it is early days yet. The draft text, released in mid-July, will now enter that curious black box that is the EUs legislative machinery, and exactly when and how it emerges is, at the moment, anyones guess. What can be said at this stage is that there is wide relief right across the healthcare community in Europe that these proposals allow the chance of at last dragging the current legal frameworkcreated in the hugely different scientific and technological circumstances of 20 years agokicking and screaming into the second quarter of the 21st century (which it will be by the time any new rule proposed comes into force).

Expectations are highand diverse. The scope of the products covered by the legislation is wide, from blood transfusions to plasma collection, from IVF to plasma-derived medicines (PDMPs) and to transplants of bone marrow or stem cells or corneas, and extending as far as breast milk and fecal microbiota. The proposed new rules imply big changes for companies working on advanced therapy medicinal products (ATMPs) and on PDMPsand are accordingly provoking anxieties as well as hopes, not least because an EU-wide authorization procedure is foreseen, with upfront risk assessment and clinical outcome data collection requirements. Even if the proposals insist these requirements will be proportionate to the identified risks, these are the sort of suggestions that cause company bosses to lose sleep over yet another round of new regulation.

EuropaBio, representing many European biotech companies, welcomed the proposal as an avenue that can support the growth of ATMPs and allow Europe to ensure it reclaims its title as a global leader in ATMP innovation. According to Claire Skentelbery, its director general, establishing a predictable, future-proof, and fair SoHO framework is critical for the sector, as requirements for donation, procurement, and testing apply to blood, tissues, and cells used in the production of ATMPs.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), with many member companies involved in ATMP development, was also glad to see the proposal emerge. But its early reaction highlighted concerns over the risk that the new rules could unhelpfully spill over into regulation of ATMPs, where, for instance, borderline issues frequently emerge when blood cells are used as starting materials for ATMP manufacture. As starting material for ATMPs, maintaining the clear classification between blood, tissues and cells, and ATMPs is crucial to provide clarity and appropriate regulatory standards when developing these transformative treatments, said EUCOPE. And in a clear hint of more reserved position, it added: We will stay active around the new SoHO regulation discussion.

The industry-backed European Alliance for Transformative Therapies (TRANSFORM) says it expects the outcome to reflect exigence of high quality standards, and, like EUCOPE, insists on retaining a clear distinction between advanced therapies and blood, tissues, and cells.The US-based Alliance for Regenerative Medicine greeted the proposal as holding the promise of improving patient safety while establishing greater legal and regulatory certainty for patients and developersagain with an emphasis on maintaining clear regulatory distinctions between starting materials and ATMPs. The EUs ATMP classification has established the region as a global leader in the regulation of cell and gene therapies, it saysurging that determining the classification of borderline cases between SoHOs and ATMPs should be based on the advice of the European Medicines Agency.

Another industry grouping engaged in PDMPs also took a conspicuously conditional stance on the proposals. The Plasma Protein Therapeutics Association said it welcomes positive developments but regrets missed opportunities to support both donors and patients. In particular, it fears not enough will be done to increase supplies of the plasma at the heart of the crucial and often irreplaceable rare disease treatments its members manufacture.

The declared aims of the EUs proposal are to increase the safety and quality of the processes in which these substances are donated and used, and to boost their supply and to ease their availability. The EU says it wants to offer support for innovation. But how far any such support will turn out to be balanced with new obstacles is what is behind the industry caution.

Reflector is Pharmaceutical Executives correspondent in Brussels

Read the rest here:
Optimism Abounds On New EU Blood And Tissue Rules - Pharmaceutical Executive

HAEMOGLOBIN IS a protein in your red blood cells. Your red blood cells carry oxygen throughout your body. If you have a condition that affects your bodys ability to make red blood cells, your haemoglobin levels may drop. Low haemoglobin levels may be a symptom of several conditions, including different kinds of anaemia and cancer.

If a disease or condition affects your bodys ability to produce red blood cells, your haemoglobin levels may drop. When your haemoglobin level is low, it means your body is not getting enough oxygen, making you feel very tired and weak.

Normal haemoglobin levels are different for men and women. For men, a normal level ranges between 14.0 grams per decilitre (gm/dL) and 17.5 gm/dL. For women, a normal level ranges between 12.3 gm/dL and 15.3 gm/dL. A severe low-haemoglobin level for men is 13.5 gm/dL or lower. For women, a severe low haemoglobin level is 12 gm/dL.

Your doctor diagnoses low haemoglobin by taking samples of your blood and measuring the amount of haemoglobin in it. This is a haemoglobin test. They may also analyse different types of haemoglobin in your red blood cells, or haemoglobin electrophoresis.

Several factors affect haemoglobin levels and the following situations may be among them:

Your body produces red blood cells and white blood cells in your bone marrow. Sometimes, conditions and diseases affect your bone marrows ability to produce or support enough red blood cells.

Your body produces enough red blood cells, but the cells are dying faster than your body can replace them.

You are losing blood from injury or illness. You lose iron any time you lose blood. Sometimes, women have low haemoglobin levels when they have their periods. You may also lose blood if you have internal bleeding, such as a bleeding ulcer.

Your body cannot absorb iron, which affects your bodys ability to develop red blood cells.

You are not getting enough essential nutrients like iron and vitamins B12 and B9.

Your bone marrow produces red blood cells. Diseases, conditions and other factors that affect red blood cell production include:

Lymphoma: This is a term for cancers in your lymphatic system. If you have lymphoma cells in your bone marrow, those cells can crowd out red blood cells, reducing the number of red blood cells.

Leukaemia: This is cancer of your blood and bone marrow. Leukaemia cells in your bone marrow can limit the number of red blood cells your bone marrow produces.

Anaemia: There are many kinds of anaemias involving low-haemoglobin levels. For example, if you have aplastic anaemia, the stem cells in your bone marrow dont create enough blood cells. In pernicious anaemia, an autoimmune disorder keeps your body from absorbing vitamin B12. Without enough B12, your body produces fewer red blood cells.

Multiple Myeloma: This causes your body to develop abnormal plasma cells that may displace red blood cells.

Chronic Kidney Disease: Your kidneys dont produce the hormone that signals to your bone marrow to make red blood cells. Chronic kidney disease affects this process.

Antiretroviral medications: These medications treat certain viruses. Sometimes these medications damage your bone marrow, affecting its ability to make enough red blood cells.

Chemotherapy: Chemotherapy may affect bone marrow cells, reducing the number of red blood cells your bone marrow produces.

Doctors treat low haemoglobin by diagnosing the underlying cause. For example, if your haemoglobin levels are low, your healthcare provider may do tests that reveal you have iron-deficiency anaemia. If that is your situation, they will treat your anaemia with supplements. They may recommend that you try to follow an iron-rich diet. In most cases, treating the underlying cause of anaemia will bring the haemoglobin level up.

Many things can cause low haemoglobin, and most of the time you cannot manage low haemoglobin on your own. But eating a vitamin-rich diet can help maintain your red blood cells. Generally, a balanced diet with a focus on important nutrients is the best way to maintain healthy red blood cells and haemoglobin.

keisha.hill@gleanerjm.comSOURCE: Centres for Disease Control and Prevention

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Factors that affect haemoglobin levels and how to detect when it's low - Jamaica Gleaner

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IrelandUruguay, Eastern Republic ofUzbekistanVanuatuVenezuela, Bolivarian Republic ofViet Nam, Socialist Republic ofWallis and Futuna IslandsWestern SaharaYemenZambia, Republic ofZimbabwe

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BUDDY SCOTT: Love stems from the Father | Brazos Living | thefacts.com - Brazosport Facts

The media continues the one-handed count of patients that seem to be cured of HIV as a man who has lived with the disease since the 1980s has been in remission for 17 months.

The story is always the samethey seem to be cured, and they get a cool nicknamein this case the City of Hope Patient, after Duarte, California, where he was treated.

The difference in this case was the treatmenta bone marrow transplant to treat blood cancer leukemia from a donor who was naturally resistant to the virus.

The most remarkable difference however, is that he is only patient cured of HIV by coincidence.

The man had developed leukemia, and took the bone marrow transplant for that reason. As it happened, the donor was resistant to HIV, and taught the mans body to create an immune response against the virus.

RELATED: Worlds Second Person Cured of HIV: 40-Year-old Man is Confirmed to Be 30 Months Virus-Free

This is also the first one who got it during the epidemic of HIV/AIDS that took so many lives.

When I was diagnosed with HIV in 1988, like many others, I thought it was a death sentence, said the City of Hope Patient. I never thought I would live to see the day that I no longer have HIV.

SIMILAR: Two Patients Make History After Essentially Being Cured of HIV Using Stem Cell Transplant

So far, only three people have been seemingly cured of human immunodeficiency virus (HIV) which weakens the bodys immune system and leads to the more severe AIDS (autoimmune deficiency syndrome) which can be lethal.

The man no longer takes antiretroviral drugs, the only treatment for HIV. A bone marrow transplant is not a likely future cure, do to it being a tricky and side-effectual procedure.

Nevertheless, all cure cases have been those where a patient is given a transplant of some kind, mostly stem cells, that contain the very rarely occurring natural immunity to the virus.

The case was reported at the AIDS 2022 conference in Montreal, Canada.

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Fourth Patient Seemingly Cured of HIV Through Wild Coincidence - Good News Network

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announces dosing of the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525).

We are excited to further advance the development of GDA-201, a NAM-enabled natural killer (NK) cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma, said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell. Our NK cells elicited an adaptive immune response in patients in the previous investigator-sponsored study with the fresh formulation of GDA-201, potentially leading to durable remissions. We are truly grateful for the contribution of all the participants and clinical collaborators who will allow us to continue studying GDA-201 in this multi-center open label trial.

The Phase 1 portion of the study is a dose escalation phase, designed to evaluate the safety of GDA-201, and will include patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma, marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in 63 patients comprised of two cohorts of patients with either FL or DLBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.

Interest in NK cell therapies has increased in recent years as a potential alternative to current cell therapies, as NK cells have the potential to be effective in hematological and solid tumors while avoiding common safety issues, said Veronika Bachanova, M.D., Ph.D., University of Minnesota. We are particularly excited about Gamidas cryopreserved formulation of GDA-201, which has potential as a new treatment option for patients.

GDA-201 leverages Gamida Cells proprietary NAM (nicotinamide) technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. Two-year data on outcomes and cytokine biomarkers associated with survival data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%91%). In this study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There were no incidents of cytokine release syndrome, neurotoxic events, graft versus host disease or marrow aplasia.

About NAM Technology

Our NAM-enabled technology, supported by positive Phase 3 data for omidubicel, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM, we can expand and metabolically modulate multiple cell types including stem cells and NK cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About GDA-201

Gamida Cell applied the capabilities of its NAM-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard-of-care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves ADCC and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit https://www.gamida-cell.com. For more information on the Phase 1/2 clinical trial of GDA-201, please visit http://www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About Gamida Cell

Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to: the timing of initiation of the expansion portion of the currently ongoing Phase 1/2 clinical trial of GDA-201, as well as the progress of, and data reported from, this clinical trial; the potentially life-saving or curative therapeutic and commercial potential of Gamida Cells product candidates (including omidubicel and GDA-201); and Gamida Cells expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cells goals, expectations, or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including statements related to: the impact that the COVID-19 pandemic could have on our business; the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics; and the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on May 12, 2022, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

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Gamida Cell Announces Dosing of First Patient in Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201 - Business Wire

In short, stem cells initiate the production of new tissue cells, which can then replace their diseased counterparts.

Mesenchymal stem cells (MSCs) are adult stem cells found in many areas of the body such as bone marrow. The unique thing about these cells is their compatibility with a range of tissues such as bone, cartilage, muscle, or fat. MSCs respond to injury or disease by migrating to these damaged areas, where they restore tissue function by replacing the damaged cells.

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It has recently been shown that the success of MSCs relies on their ability to release cell signals their mechanism to initiate tissue regeneration. These signals are packaged into extracellular vehicles (EVs) which are essentially bubbles of information. These are released by MSCs and taken up by the injured or diseased tissue cells to kickstart their inbuilt process of regeneration.

Through funding from the Royal Society of Edinburgh, research has started into the development of artificial EVs as a viable alternative to cell therapy. These EVs will contain the key molecules released by stem cells when they are responding to injury cues in the body.

The power to induce tissue regeneration would provide a significant new tool in biomedical treatment, such as incorporating EVs into synthetic hydrogels within a wound dressing to encourage and accelerate healing.

Within the lab setting, we have been able to manipulate stem cell cultures to produce EVs with different signal make-ups, and accurately identify their properties.

Controlling and identifying the different make-ups contained in EV signals which in turn induce different cell responses is crucial if we want to operationalise their use in medicine.

We now aim to synthesise artificial vesicles, or bubbles, for different clinical problems, such as, for example, bubbles with potent wound-healing properties that would help our ability to use new artificial stem cell therapy.

The research is underway and it is showing promise that we may be able to harness the regenerative power of stem cells in the near future.

An artificial EV-based approach also has several advantages over stem cell-based therapies, such as having increased potency and greater consistency in treatment, and at a lower cost to carry out.

Both inside and on the surface of the body, we would have the ability to induce a process vital to medical treatment we work with every day and, in turn, open a whole new avenue of possibilities in biomedical science.

Dr Catherine Berry is a reader in the Centre for the Cellular Microenvironment at the University of Glasgow, and a recipient of the Royal Society of Edinburghs personal research fellowship in 2021. This article expresses her own views. The RSE is Scotland's national academy, bringing great minds together to contribute to the social, cultural and economic well-being of Scotland. Find out more at rse.org.uk and @RoyalSocEd.

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Stem cells: Could we gain the power to induce cell regeneration? Dr Catherine Berry - The Scotsman

The stock price of Verb Technology Company Inc (VERB) an innovative nutraceutical company and a pioneer in the field of stem cell nutrition increased by 15.07% today. Investors responded positively to Stemtech Corporation announcing that Stemtech has adopted a suite of sales enablement software solutions, developed by Verb Technology Company, including verbCRM, VERBs white-labeled interactive video-based customer relationship management application, and verbLIVE, VERBs interactive livestream eCommerce and shoppable video and webinar application, for use in direct selling and customer and prospect communications by its network of Independent Business Partners (IBPs).

Stemtech specializes in creating products and formulas that are patent protected in the U.S. and international markets. And its patented formulas help the release, circulation and migration of the bodys adult stem cells from its bone marrow. The products are all-natural, plant-based, and manufactured under cGMP (Current Good Manufacturing Practices) under the auspices of the Dietary Supplemental Health and Education Act (DSHEA). Stemtechs primary marketing and distribution channel are through a direct sales structure, which offers supplemental and residual income-earning potential to IBPs.

VERB is the leader in interactive video-based sales enablement applications, including interactive livestream eCommerce and shoppable video, webinar, CRM, and marketing applications for enterprises and entrepreneurs., verbCRM, VERBs interactive video-based customer relationship and content management system, will be used as a selling tool by Stemtechs IBPs in marketing its products, acquiring new customers, and strengthening existing customer relationships. And the platform allows users to easily manage, share directly with customers and prospects and through social media, and track interactive content, such as product literature and media, demo videos, and personalized videos.

Plus it provides interaction analytics so IBPs can determine which content is resonating with their prospects and assess overall customer engagement and campaign effectiveness. And this enables IBPs to focus their time and energy more effectively on high-probability sales prospects who have shown interest, thereby increasing their sales conversion rates.

Stemtechs verbCRM implementation also includes VERBs Business Tiles feature, which integrates verbCRM directly into Stemtechs back-office systems, allowing IBPs access to key reports and metrics relevant to improving their business-building efforts natively on the verbCRM app. And verbLIVE, VERBs powerful interactive livestream e-commerce application, will be used by IBPs to engage directly with customers and prospects during live video sessions that allow viewers to quickly buy, receive additional product information, set up appointments, and access other customizable interactive features through clickable in-video buttons.

KEY QUOTES:

We are dedicated to supporting and empowering Stemtechs expansive network of Independent Business Partners by equipping them with the most current and best-in-class digital technology sales tools available. With VERBs sales enablement applications, our IBPs will be able to capitalize on our social media assets and content and more effectively engage with customers and prospects via livestream video to bolster our customer acquisition efforts and increase sales conversion rates.

John Meyer, President and COO of Stemtech

Our select Field IBPs who have been beta testing the new mobile app Stemtech Advance Office, powered by VERB, has been very successful and we are all most excited to launch shortly.

Stemtechs Vice President of Global Performance Sandra Kazickaite

We are thrilled to include Stemtech among the forward-thinking companies that have embraced VERBs interactive video and livestreaming technology to grow sales. VERB has developed a suite of easy-to-use products that create a friction-free, fun, social, and video-based sales experience to enhance customer engagement, while providing real-time viewer engagement analytics for more effective follow-ups that drive sales conversion rates. We are proud to be Stemtechs technology partner to help empower its Independent Business Partners with industry-leading sales enablement tools.

Rory Cutaia, CEO of VERB

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.

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Verb Technology (VERB) Stock: Why It Jumped Up 15.07% Today - Pulse 2.0

The new report by Expert Market Research titled, Global Stem Cell Banking Market Report and Forecast 2021-2026, gives an in-depth analysis of the globalstem cell banking market, assessing the market based on its segments like Service type, product type, utilisation, bank type, application, and major regions like Asia Pacific, Europe, North America, Middle East and Africa and Latin America. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report summary@https://bityl.co/CPix

The key highlights of the report include:

Market Overview (2021-2026)

The global stem cell bank market is primarily driven by the advancements in the field of medicine and the rising prevalence of genetic and degenerativediseases. Further, the increasing research and development of more effective technologies for better preservation, processing, and storage of stem cells are aiding the growth. Additionally, rising prevalence of chronic diseases globally is increasing the for advances inmedicaltechnologies, thus pushing the growth further. Moreover, factors such as rising health awareness, developinghealthcare infrastructure, growing geriatric population, and the inflatingdisposableincomes are expected to propel the market in the forecast period.

Industry Definition and Major Segments

Stem cells are undifferentiated cells present in bone marrow,umbilical cordadipose tissue and blood. They have the ability to of differentiate and regenerate. The process of storing and preserving these cells for various application such as gene therapy, regenerative medicine and tissue engineering is known as stem cell banking.

Explore the full report with the table of contents@https://bityl.co/CPiy

By service type, the market is divided into:

Based on product type, the industry can be segmented into:

The market is bifurcated based on utilization into:

By bank type, the industry can be broadly categorized into:

Based on application, the industry can be segmented into:

On the basis of regional markets, the industry is divided into:

1 North America1.1 United States of America1.2 Canada2 Europe2.1 Germany2.2 United Kingdom2.3 France2.4 Italy2.5 Others3 Asia Pacific3.1 China3.2 Japan3.3 India3.4 ASEAN3.5 Others4 Latin America4.1 Brazil4.2 Argentina4.3 Mexico4.4 Others5 Middle East & Africa5.1 Saudi Arabia5.2 United Arab Emirates5.3 Nigeria5.4 South Africa5.5 Others

Market Trends

Regionally, North America is projected to dominate the global stem cell bank market and expand at a significant rate. This can be attributed to increasing research and development for stem cell application in various medical fields. Further, growing investments of pharmaceutical players and development infrastructure are other factors that are expected to stem cell bank market in the region. Meanwhile, Asia Pacific market is also expected to witness fast growth owing to the rapid development in healthcare facilities and increasing awareness of stem cell banking in countries such as China, India, and Indonesia.

Key Market Players

The major players in the market are Cryo-Cell International, Inc., Smart Cells International Ltd., CSG-BIO Company, Inc., CBR Systems Inc., ViaCord, LLC, LifeCell International Pvt. Ltd., and a few others. The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

About Us:

Expert Market Research (EMR) is leading market research company with clients across the globe. Through comprehensive data collection and skilful analysis and interpretation of data, the company offers its clients extensive, latest and actionable market intelligence which enables them to make informed and intelligent decisions and strengthen their position in the market. The clientele ranges from Fortune 1000 companies to small and medium scale enterprises.

EMR customises syndicated reports according to clients requirements and expectations. The company is active across over 15 prominent industry domains, including food and beverages, chemicals and materials, technology and media, consumer goods, packaging, agriculture, and pharmaceuticals, among others.

Over 3000 EMR consultants and more than 100 analysts work very hard to ensure that clients get only the most updated, relevant, accurate and actionable industry intelligence so that they may formulate informed, effective and intelligent business strategies and ensure their leadership in the market.

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Company Name: Claight CorporationContact Person: Steven Luke, Corporate Sales Specialist U.S.A.Email:sales@expertmarketresearch.comToll Free Number: +1-415-325-5166 | +44-702-402-5790Address: 30 North Gould Street, Sheridan, WY 82801, USAWebsite:https://www.expertmarketresearch.com

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*We at Expert Market Research always thrive to give you the latest information. The numbers in the article are only indicative and may be different from the actual report.

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Global Stem Cell Banking Market To Be Driven At A CAGR Of 13.5% In The Forecast Period Of 2021-2026 This Is Ardee - This Is Ardee

SINGAPORE - A Singaporean doctorwho is one of the top cell therapy experts in the worldhas been appointed to a World Health Organisation (WHO) expert panel.

Dr Mickey Koh is so sought-after in his field that for the past 15 years, he has been holding two jobs in two different countries.

The 56-year-old shuttles between England and Singapore, spending six weeks at a time in London, where he oversees the haematology department and looks after bone marrow transplant patients at St George's University Hospital, before returning to Singapore for a week and a half to head the cell therapy programme at the Health Sciences Authority.

Cell therapy is a growing field of medicine that uses living cells as treatment for a variety of diseases and conditions. This is an increasingly important therapeutic area and both his employers have agreed to his unusual schedule.

Over in London, Dr Koh is head of the Haematology Department at St George's Hospital and Medical School. In Singapore, he is the programme and medical director of the cell and gene therapy facility at the Health Sciences Authority.

In May, Dr Koh was selected to be on the WHO Expert Advisory Panel on Biological Standardisation.

Individuals on the panel have to be invited by WHO to apply, and are well recognised in their respective scientific fields. Eminent names on the panel include the current president of the Paul-Ehrlich-Institut in Germany, which is the country's federal agency, medical regulatory body and research institution for vaccines and biomedicine.

The WHO panel, which is made up of about 25 members, provides detailed recommendations and guidelines for the manufacturing, licensing and standardisation of biological products, which include blood, monoclonal antibodies, vaccines and, increasingly, cell-based therapeutics.

The recommendations and advice are passed on to the executive board of the World Health Assembly, which is the decision-making body of WHO.

Dr Koh's role had to be endorsed by the British government and was a direct appointment by the director-general of WHO.

His appointment as a panel expert will last for a term of four years.

Speaking to The Straits Times, Dr Koh shared his thoughts about the importance of regulation: "We are well aware that there is a very lucrative worldwide market peddling unproven stem cell treatments, where side effects are often unknown, and such unregulated practice can result in serious harm.

"This is already happening. People are claiming that you can use stem cells to treat things like ageing, and even very serious conditions like strokes, without any evidence."

With many medications now taking the form of biologics - a drug product derived from biological sources such as cells - the next wave of treatment would be the utilisation of these cells for the treatment of a wide range of diseases, Dr Koh said.

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S'porean doctor, a sought-after top expert in cell therapy, appointed to WHO expert panel - The Straits Times

Presentation

A 17-year-old female presented to a dental school clinic with a chief complaint of a sudden, painless swelling of her gingivae (figures 1 and 2). She had previously gone to a local emergency room. There, her condition was dismissed as a lack of oral hygiene, and she was told to go to a dental provider. The patient had social concerns as she was being ridiculed at school for her condition. She was not pregnant and took no medications. The staff periodontist submitted a large tissue sample to a university pathology lab, and then he performed a gingivectomy on the swollen tissues (figure 3).

In two weeks, the patient returned for a follow-up appointment. The tissue had grown back almost to the original levels (figures 4 and 5). Note the intense red color of the maxillary gingivae.

At this follow-up, the biopsy report was available. Here is a quote from that report: The histomorphology when combined with the clinical presentation and positive staining with MPO and high proliferation index is highly suggestive of acute myeloid or promyelocytic leukemia. The patient should be quickly evaluated by hemo-oncology with this in mind.

Top causes of gingival enlargement and treatment options

Mysterious lesions, Lemonheads, extreme oral herpes, and more

An almost-vague radiodense lesion, mysterious mole, and a tongue top 5

The patient was referred to the University of Floridas Childrens Hospital, where she was treated and went into subsequent remission with chemotherapy. With a timely diagnosis and swift treatment, young people typically respond quickly and favorably. Treatment programs may include chemotherapy, radiation, stem-cell transplant, immunotherapy, or bone marrow transplant.

Myeloid leukemia involves the rapid growth of myeloid blood cells that build up in the bone marrow and prevent the normal production and maturation process. Promyelocytic leukemia is a more aggressive form of myeloid leukemia. In young individuals, these conditions are most often associated with several chromosomal abnormalities. Sudden gingival enlargement is not an uncommon symptom.1 It may occur in patients with non-Hodgkins lymphoma.2

Certain medications may initiate gingival hyperplasia. It is common in renal transplant patients who are treated with cyclosporine and a calcium channel blocker.3 Other medications such as carbamazepine, phenytoin, topiramate, and valproic acid are all possible triggering agents.4 Finally, certain immunosuppressants have the potential to trigger gingival hyperplasia.

Editors note:This article first appeared inThrough the Loupesnewsletter, a publication of the Endeavor Business Media Dental Group.Read more articlesandsubscribetoThrough the Loupes.

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Oral symptoms of systemic pathology in a 17-year-old female - DentistryIQ

Market Overview

Thecell culture media marketis expected to cross USD 4.33 billion by 2027 at a CAGR of8.33%.

Market Dynamics

The markets growth is being fueled by a diverse range of cell culture media applications, increased research and development in the pharmaceutical industry, an increase in the prevalence of chronic diseases, and increased expansion and product launches by major players. Over the last few decades, advancements in cell culture technology have accelerated. It is widely regarded as one of the most dependable, robust, and mature technologies for biotherapeutic product development.

The high cost of cell culture media and the risk of contamination, on the other hand, are impeding the markets growth. However, the growing emphasis on regenerative and personalized medicine is likely to spur growth in the global cell culture media market.

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Competitive Dynamics

The notable players are the Merck KGaA (Germany), Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific Inc. (US), Lonza (Switzerland), GE Healthcare (US), Becton, Dickinson and Company (US), HiMedia Laboratories (India), Corning Incorporated (US), PromoCell (Germany), Sera Scandia A/S (Denmark), The Sartorius Group (Germany), and Fujifilm Holdings Corporation (Japan).

Segmental Analysis

The global market for cell culture media has been segmented according to product type, application, and end user.

The market has been segmented by product type into classical media, stem cell media, serum-free media, and others.

Further subcategories of stem cell culture media include bone marrow, embryonic stem cells, mesenchymal stem cells, and neural stem cells.

The market is segmented into four application segments: drug discovery and development, cancer research, genetic engineering, and tissue engineering and biochemistry.

The market is segmented by end user into biochemistry and pharmaceutical companies, research laboratories, academic institutions, and pathology laboratories.

Regional Overview

According to region, the global cell culture media market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East & Africa.

The Americas dominated the global cell culture media market. The large share is attributed to the presence of major manufacturers, rising disease prevalence resulting in increased demand for drugs and other medications, technological advancements in the preclinical and clinical segments, growing public awareness, and high disposable income.

Europe ranks second in terms of market size for cell culture media. Factors such as an increase in the biopharmaceutical sector in the European region, increased government initiatives to promote research to find a cure for the growing number of chronic diseases, an increase in the number of pharmaceutical manufacturers, improving economies, a high disposable income per individual, and increased healthcare spending are all contributing to the markets growth in this region. The European market is expected to be driven by expanding R&D activities and a developing biopharmaceutical sector.

Asia-Pacific held the third-largest market share, owing to the presence of numerous research organizations, low manufacturing costs, low labor costs, developing healthcare infrastructure, and increased investment by American and European market giants in Asian countries such as China and India.

The Middle East and Africa, with limited economic development and extremely low income, held the smallest market share in 2019 but is expected to grow due to growing public awareness and demand for improved healthcare facilities in countries, as well as rising disposable income.

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Cell Culture Media Market: Competitive Approach, Breakdown And Forecast by 2027 - Digital Journal

Tecartus (Brexucabtagene Autoleucel) First and Only CAR T in Europe to Receive Positive CHMP Opinion to Treat Adults 26+ with r/r ALL

If Approved, it will Address a Significant Unmet Need for a Patient Population with Limited Treatment Options

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). If approved, Tecartus will be the first and only Chimeric Antigen Receptor (CAR) T-cell therapy for this population of patients who have limited treatment options. Half of adults with ALL will relapse, and median overall survival (OS) for this group is only approximately eight months with current standard-of-care treatments.

Kites goal is clear: to bring the hope of survival to more patients with cancer around the world through cell therapy, said Christi Shaw, CEO, Kite. Todays CHMP positive opinion in adult ALL brings us a step closer to delivering on the promise that cell therapies have to transform the way cancer is treated.

Following this positive opinion, the European Commission will now review the CHMP opinion; the final decision on the Marketing Authorization is expected in the coming months.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant, creating a significant burden on a patients quality of life, said Max S. Topp, MD, professor and head of Hematology, University Hospital of Wuerzburg, Germany. If approved, patients in Europe will have a meaningful advancement in treatment. Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

Results from the ZUMA-3 international multicenter, single-arm, open-label, registrational Phase 1/2 study of adult patients (18 years old) with relapsed or refractory ALL, demonstrated that 71% of the evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) with a median follow-up of 26.8 months. In an extended data set of all patients dosed with the pivotal dose (n=78) the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for responders (patients who achieved CR or CRi). Among efficacy-evaluable patients, median duration of remission (DOR) was 18.6 months. Among the patients treated with Tecartus at the target dose (n=100), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 25% and 32% of patients, respectively, and were generally well-managed.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter (US, Canada, EU), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and allo-SCT rate were assessed as secondary endpoints.

About Acute Lymphoblastic Leukemia

ALL is an aggressive type of blood cancer that develops when abnormal white blood cells accumulate in the bone marrow until there isnt any room left for blood cells to form. In some cases, these abnormal cells invade healthy organs and can also involve the lymph nodes, spleen, liver, central nervous system and other organs. The most common form is B cell precursor ALL. Globally, approximately 64,000 people are diagnosed with ALL each year, including around 3,300 people in Europe.

About Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. In ZUMA-2, CRS occurred in 91% (75/82) of patients receiving Tecartus, including Grade 3 CRS in 18% of patients. Among the patients who died after receiving Tecartus, one had a fatal CRS event. The median time to onset of CRS was three days (range: 1 to 13 days) and the median duration of CRS was ten days (range: 1 to 50 days). Among patients with CRS, the key manifestations (>10%) were similar in MCL and ALL and included fever (93%), hypotension (62%), tachycardia (59%), chills (32%), hypoxia (31%), headache (21%), fatigue (20%), and nausea (13%). Serious events associated with CRS included hypotension, fever, hypoxia, tachycardia, and dyspnea.

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 81% (66/82) of patients with MCL, including Grade 3 in 37% of patients. The median time to onset for neurologic events was six days (range: 1 to 32 days) with a median duration of 21 days (range: 2 to 454 days) in patients with MCL. Neurologic events occurred in 87% (68/78) of patients with ALL, including Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS.

The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus.

Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of febrile neutropenia (11 (14%)) plus the concurrent events of fever and neutropenia (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion.

Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus.

Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.

Adverse Reactions: The most common non-laboratory adverse reactions ( 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions ( 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Tecartus; the risk that physicians may not see the benefits of prescribing Tecartus for the treatment of blood cancers; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Tecartus including BOXED WARNING, is available at http://www.kitepharma.com and http://www.gilead.com .

Kite, the Kite logo, Tecartus and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies .

View source version on businesswire.com: https://www.businesswire.com/news/home/20220722005258/en/

Jacquie Ross, Investorsinvestor_relations@gilead.com

Anna Padula, Mediaapadula@kitepharma.com

Source: Gilead Sciences, Inc.

Read more from the original source:
Kite's CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) - Gilead Sciences

Josh, Harper and Meagan in June 2022

Two years ago, Meagan stood in a hospital room at Seattle Childrens cradling her 1-year-old daughter, Harper, against her chest. Her fianc, Josh, huddled close to them and kissed the thinning hair on top of their babys head.

A feeding tube was routed through Harpers nose and her eyes were brimming with tears. Exhausted, she snuggled into her moms arms as a photographer took their picture.

Meagan and Josh feared those would be the last photos taken of their baby girl.

Six months before, Harper became seriously ill. After multiple visits to their pediatrician in Yakima, Meagan took her to an emergency room where blood tests revealed Harper had leukemia.

It was shocking, Meagan says. Thirty minutes later we were on an emergency flight to Seattle Childrens.

The family didnt return home for nearly two years.

The type of leukemia Harper had acute lymphoblastic leukemia (ALL) is typically harder to treat and has lower survival rates when it occurs in infants who are less than a year old.

Harpers case was exceptionally challenging. She didnt respond to standard chemotherapy, even after providers added a medication designed to sensitize her leukemia to the treatment.

Her care team, which included Seattle Childrens High-Risk Leukemia Program, believed a stem cell transplant would give Harper the best chance of surviving, but they had to eliminate the majority of her leukemia cells first.

Drs. Kasey Leger and Brittany Lee, Harpers primary oncologists, started her on a novel immunotherapy medication, called blinatumomab, which effectively destroyed many of her ALL cells.

Unfortunately, two weeks later, the team discovered some of Harpers ALL cells had morphed into a different blood cancer acute myeloid leukemia (AML). This rare occurrence, called lineage switch, occurs in less than 5% of infant ALL cases.

It was a roller coaster, Josh says. She didnt do anything they expected her to do. It felt like every day we had to come up with a new plan.

Drs. Leger and Lee gave Harper a different kind of chemotherapy that destroyed the new AML cells. Still, some of her ALL cells remained, so the team gave Harper blinatumomab again which finally suppressed her cancer enough for her to have a stem cell transplant just before her first birthday.

Harper and her mom, Meagan, celebrating Harpers first birthday shortly after her stem cell transplant

The team had done everything they could to get Harper healthy enough for a stem cell transplant, hopeful it would be the treatment that finally cured her. Tragically, Harpers leukemia was back less than a month later.

When leukemia comes back so soon after transplant, patients have very few treatment options, if any, says Dr. Corinne Summers, Harpers stem cell transplant specialist. Many patients will not survive long term.

Harpers parents were terrified they were going to lose her.

Her bone marrow was packed with leukemia, Josh remembers. You could tell the life was slipping out of her and she just looked like it was going to be the end.

After Harpers stem cell transplant failed, the family met with end-of-life specialists and scheduled a special photo session to create memories that they would carry forward

They struggled to decide if they should continue treatment.

How do you know when enough is enough? Meagan says. When do you say, We cant do this to her anymore? Harper couldnt tell us how she was feeling, so it was all our decision.

Meagan and Josh worked closely with the care team to decide what to do next.

Those conversations were emotional for all of us, says Dr. Lee. Thankfully, we had a close, trusting relationship with their family and were able to give recommendations that reflected what they wanted for their daughter and what they felt was most important.

After much consideration, Meagan and Josh decided Harper was strong enough to continue treatment.

Drs. Leger and Lee filed a compassionate use request with the Food and Drug Administration to give Harper an investigational chemotherapy drug called venetoclax. Unfortunately, the treatment didnt work.

Collaborating with the family, the team decided to try giving Harper blinatumomab one more time. There was no evidence suggesting the medication would work so soon after a bone marrow transplant and with such a high burden of leukemia, but within a week it eliminated 98% of Harpers cancer cells.

Family is a critical piece of the team, Dr. Leger says. And Harper is fortunate to have amazing parents who were at her bedside 24/7 and had a beautiful way of advocating for her. They challenged us to leave no stone unturned and partnered with us throughout her treatment to keep figuring out a way forward.

With Harpers leukemia under control, the team searched for a way to wipe out any remaining cancer cells and keep her disease from coming back. Doctors in Childrens Cancer and Blood Disorders Center lead national research groups such as the Childrens Oncology Group, so they have access to trials around the world. However, Harpers care team found the best treatment for her was at Seattle Childrens Hospital, in partnership with Seattle Childrens Therapeutics.

Harpers T-cells were removed through a process called apheresis before they were reprogrammed to target her cancer cells and infused back into her blood

Harper was enrolled in one of Childrens T-cell immunotherapy clinical trials. The treatment involves re-programming a patients T cells (a type of white blood cell) to target and destroy their cancer cells.

After her T-cell therapy, Harper was finally in remission.

Meagan cried with relief when she found out. Harper would not be here right now if it wasnt for everybody at Seattle Childrens, she says. From day one, theyve been comforting and compassionate. They bend over backwards to keep families involved and helped us fight for our child.

To keep her in remission, Harper was given six antigen-presenting cell boosters, which kept her reprogrammed T cells circulating through her blood longer. She received the last booster earlier this year and is still in remission today.

Harper had a very unique disease in that her leukemia manifested as both ALL and AML, says Dr. Leger. Thankfully, we have team members with deep expertise in each of those diseases. Having internationally recognized chemotherapy, transplant and immunotherapy specialists on our team allowed us to be creative with her care when she needed to go beyond the standard pathways.

Today, Harper is a joyful, boisterous 3-year-old who loves experimenting with musical toys and splashing around in her bath or kiddie pool. One of her favorite things to do is grab Meagan by the hair and squish their faces together.

Because of the treatments Harper received at such a young age and the extended time she spent in the hospital, Harper is behind on some developmental milestones like speaking and walking. Still, Meagan and Josh say shes catching up.

Shes starting to bloom and take off and its so nice to see, Meagan says. At the same time, we cant get too comfortable. We know how relentless her disease is and that it could come back one day.

Harper plays in a pool, one of her favorite activities, in June 2022

Harpers family encourages community members to support cancer research at Childrens so that new treatments can be developed for Harper and other kids like her.

Without donors, Harper probably wouldnt be alive right now, Josh says. The treatments she had were developed in just the last few years. If people dont step up and donate, those programs arent there. Those drugs arent invented. Cancer treatment has come a really long way and thats because of donors stepping up to make that happen.

Learn more about Seattle Childrens High-Risk Leukemia Program and Cancer and Blood Disorders Center.

Related

Read more here:
No Stone Unturned: Seattle Children's High-Risk Leukemia Experts Specialize in the Toughest Cases - On the Pulse - On the Pulse - On the Pulse

New Jersey, United States TheStem Cell TherapyMarket research guides new entrants to obtain precise market data and communicates with customers to know their requirements and preferences. It spots outright business opportunities and helps to bring new products into the market. It identifies opportunities in the marketplace. It aims at doing modifications in the business to make business procedures smooth and make business forward. It helps business players to make sound decision making. Stem Cell Therapy market report helps to reduce business risks and provides ways to deal with upcoming challenges. Market information provided here helps new entrants to take informed decisions making. It emphasizes on major regions of the globe such as Europe, North America, Asia Pacific, Middle East, Africa, and Latin America along with their market size.

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Key Players Mentioned in the Stem Cell Therapy Market Research Report:

Osiris Therapeutics Medipost Co. Ltd., Anterogen Co. Ltd., Pharmicell Co. Ltd., HolostemTerapieAvanzateSrl, JCR Pharmaceuticals Co. Ltd., Nuvasive RTI Surgical Allosource

Stem Cell TherapyMarket report consists of important data about the entire market environment of products or services offered by different industry players. It enables industries to know the market scenario of a particular product or service including demand, supply, market structure, pricing structure, and trend analysis. It is of great assistance in the product market development. It further depicts essential data regarding customers, products, competition, and market growth factors. Stem Cell Therapy market research benefits greatly to make the proper decision. Future trends are also revealed for particular products or services to help business players in making the right investment and launching products into the market.

Stem Cell TherapyMarket Segmentation:

Stem Cell Therapy Market, By Cell Source

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

Stem Cell Therapy Market, By Therapeutic Application

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

Stem Cell Therapy Market, By Type

Allogeneic Stem Cell Therapy Autologous Stem Cell Therapy

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For Prepare TOC Our Analyst deep Researched the Following Things:

Report Overview:It includes major players of the Stem Cell Therapy market covered in the research study, research scope, market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the Stem Cell Therapy market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the Stem Cell Therapy market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the Stem Cell Therapy market by application, it gives a study on the consumption in the Stem Cell Therapy market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the Stem Cell Therapy market are profiled in this section. The analysts have provided information about their recent developments in the Stem Cell Therapy market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the Stem Cell Therapy market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the Stem Cell Therapy market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the Stem Cell Therapy market.

Key Findings:This section gives a quick look at the important findings of the research study.

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Here is the original post:
Stem Cell Therapy Market Size, Scope, Growth Opportunities, Trends by Manufacturers And Forecast to 2029 This Is Ardee - This Is Ardee

Introduction

Stem cells are highly specialized cell types with an impressive ability to self-renew, able to transform into one or even more specific cell types that play a significant role in the regulation and tissue healing process.17 To self-renew, a stem divides into two identical daughter stem cells and a progenitor cell and the embryonic and adult cells contain stem cells.1,2,8

Curing patients with serious medical conditions has been the focus of all disciplines of medical research for many years. Stem cell treatment has evolved into a highly exciting and progressed field of scientific research. Major advances have recently been introduced in fundamental and translational stem-cell-based treatment studies. As stem cell research progressed, many therapeutic options were investigated. The development of therapeutic procedures has sparked a great deal of interest.1,9 Humanity has known for many years that it is possible to regenerate lost tissue. Recently, the regenerative medicine research has taken hold, defying the tremendous scientific advances in the molecular biology sciences only. Technological advances provide limitless opportunities for transformational and potentially restorative therapies for many of humanitys most illnesses. A variety of human organs have successfully yielded stem cells. Besides this, the cell therapy is rapidly bringing good advancements in the healthcare system, intending to restore and possibly replace injured tissue, as well as organs, and ultimately restore the functional capacity of the body.2,10,11

The stem cells can be obtained from various sources of Adult (Adult body tissues), Embryonic (Embryos), Mesenchyma (Connective tissue or stroma), and Induced pluripotent stem [ips] cells (Skin cells or tissue-specific cells).3,68,1215

Due to various stem cells cellular characteristics, the therapeutic clinical possibilities of stem-cell-based treatment are considered promising. These cells can regrow and restore various types of body tissues, for this reason, they are recognized as precursor cells to all kinds of cells.15 The following are the distinguishing features: 1. Self-renewal- Divide without distinction to generate an infinite supply, 2. Multi-potency- One mature cell may distinguish more than one, 3. Pluripotency- Create all sorts of cells except for embryonic membrane cells, 4. Toti- potency- Produce various sorts of cells, including embryonic stem cells.1,2,6,7,16

Stem cells are essential human cells that really can self-renew and make a distinction into particular mature cell types.3,6 The different types of stem cells are embryonic, induced pluripotent, and adult kind of cell types. They all share the important feature of self-renewal, and the ability to discern themselves. It should be mentioned that, the stem cells are not homogeneous, but instead appear in a progressive order. Totipotent stem cells are the most basic and immature stem cells. The above cells can form a complete embryo and also extra-embryonic tissue. This one-of-a-kind efficiency is only present for a short period, starting with ovum development and completing whenever the embryo achieves the 4 to 8 cell phases. Having followed that, cells that divide until they approach the blastocyst, about which point they end up losing their totipotency and acquire a pluripotent character trait, at which cells can only distinguish through each embryonic germ stack. After a few divisions, the pluripotency character trait starts to fade and the distinguishing ability has become more lineage constrained, where its cells are becoming multipotent, indicating they could only transform into the cells connected to a cell or tissue of origin.10 Many researchers believe that adult stem cells should be used in stem cell therapies.6,17

The stem cells can be transformed into a wide range of specialized functional cell types.3,18 In response to injury or maturation, those same stem cells can propagate in massive quantities.19 Adult, embryonic, and induced pluripotent stem cells are examples of stem cell-based therapies.14,15,1921 The stem cells, due to their capability to distinguish the specific cell types requisite for a diseased tissue regeneration, can provide an effective solution, while tissue and organ transplantation are considered necessary.10 The sophistication of stem cell-based treatment interventions, on the other hand, probably leads researchers to seek stable, credible, and readily available stem cell sources capable of converting into numerous lineages. As an outcome, it is critical to exercise caution when selecting the type of stem cells to be used in therapeutic trials.12,14,22

Only with the explosive growth of basic stem cell research in recent years, the comparatively recent study sector of Translational Research had also grown exponentially, starting to build on major research knowledge and insight to advance new therapies. Once the necessary regulatory clearances have been obtained, the clinical translation process can start. Translational research is important because it acts as a filtration system, ensuring that only safe and effective therapeutic approaches start making it to the clinic.23 Recent research illustrating, the successful application of stem cell transplantation to patient populations suggests that, such restorative approaches have been used to address a wide variety of complicated ailments of future concerns.19,24

Currently, clinical trials are available for a variety of stem cell-based treatments based on adult stem cells. To date, the WHO International Clinical Experiments Registration process has recorded more than 3000 experiments involved based on adult stem cells. Furthermore, preliminary trials involving novel and intriguing pluripotent stem cell therapies have been registered. These studies findings will assist the ability to comprehend and the timeframes required to obtain effective treatments and it will contribute to a better knowledge of the different disorders or abnormalities.10

The role of stem cells in modern medicine is vital, both for their widespread application in basic research and for the opportunities they provide for developing new therapeutic strategies in clinical practice.6,16 In recent times, the number of studies involving stem cells has expanded tremendously. Globally, thousands of studies claiming to use stem cells in experimental therapies have now been in the investigation field. This may give the impression that such treatments have already been shown to be extremely effective in the context of healthcare. Despite some promising results, the vast majority of stem cell-based therapeutic applications are still in the experimental stage itself.6,25

The stem cells are a valuable resource for understanding organogenesis as well as the bodys continual regenerative capacity. These cells have brought up enormous anticipations among doctors, investigators, patients, and the public at large because of their ability to distinguish into a variety of cell types.25 These cells are necessary for living beings for a variety of reasons and can play a distinguishable role. Several stem cells can play all cell types roles, and when stimulated effectively, they can also repair damaged tissue. This capability has the potential to save lives as well as treat human injuries and tissue destruction. Moreover, different kinds of stem cells could be used for several purposes, including tissue formation, cell deficiency therapeutic interventions, and stem cell donation or retrieval.3,6,26

New research demonstrating that the successful application of stem cell treatments to patients has expressed hope that such regenerative strategies might very well one day is being used to address a wide variety of problematic ailments. Furthermore, clinical trials incorporating stem cell-based therapeutics have advanced at an alarming rate in recent years. Some of these studies had a significant impact on a wide range of medical conditions.10 As a regenerative medicine strategy, cell-based treatment is widely regarded as the most fascinating field of study in advanced science and medicine. Such technological innovation paves the way for an infinite number of transformational and potentially curable solutions to some of humanitys most pressing survival issues. Moreover, it is gradually becoming the next major concern in medical services.11

Modern data, which shows that the successful stem cell transplantation in beneficiaries has raised hopes on the certain rejuvenating approaches, will one day be used to treat many different types of challenging chronic conditions.24 Preliminary data from highly innovative investigations have documented that the prospective advancement of stem cells provides a wide range of life-threatening ailments that have so far eluded current medical therapy.2,10,11 Furthermore, clinical trials involving stem cell-based therapies have advanced at an unprecedented rate. Many of these studies had a significant impact on various disorders.19 Despite the increasing significance of articles concerning viable stem cell-based treatments, the vast majority of clinical experiments have still yet to receive full authorization for stem cell treatments confirmation.11,12,27

Even though the first case of AIDS were noted nearly 27 years ago, and the etiologic agent was noticed 25 years ago, still for the effective control of the AIDS pandemic continues to remain elusive.28 The HIV epidemic started in 1981 when a new virus syndrome defined by a weakened immune system was revealed in human populations across the globe. AIDS showed up to have a substantial reduction in CD4+ cell counts and also elevated B-cell multiplication.15,2831

The agent that causes AIDS, later named HIV, is a retroviral disease with a genomic structural system made up of 2 identical single-stranded RNA particles.3234 According to the Centres for Disease Control and Prevention, with over 1.1 million Americans are presently infected with the virus.31 Compromised immune processes in HIV and AIDS, as well as partial immune restoration, barriers are confirmed for HIV disease eradication. Innovative developmental strategies are essential to maximizing virus protection and enabling the host immune response to eliminate the virus.35

The progression of HIV infection in humans is divided into the following stages of acute infection, chronic infection, and AIDS.15,36 During the acute infection phase, the circulation has a high viral replication, is extremely infectious, that may or may not demonstrate flu-like clinical signs. In the chronic stage, the viral load is lesser than in the acute stage, and individuals are still infectious but may be symptomless. The patient has come to the end stage of AIDS whenever the CD4+ cell count begins to fall below 200 cells/mm or even when opportunistic infections are advanced.15,36

There are currently two types of HIV isolated HIV-1 and HIV-2.15,37,38 However, HIV-1 is the most common cause of AIDS throughout the world, while HIV-2 is only found in a few areas of an African country. Although both virions can cause AIDS, HIV-2 infection is much more likely to occur in central nervous system disorder.15 Besides this, HIV-2 seems to be less infectious than HIV-1, and HIV-2 infection induces AIDS to develop more slowly. Even though both HIV-1 and HIV-2 have a comparable genetic structure comprised of group-specific antigen, polymerase, and envelope genes, their genome organizational structures are differed.15,3739

HIV infiltrates immune cell types, CD4+ T cell types, and monocytes, resulting in a drop in T-cell counts below a critical level and the failure of cell-mediated immune function.15,40 The glycoprotein (gp120) observed in the virion envelope comes into contact with the CD4 particle with high affinity, allowing HIV to infect T cells. By interacting with their co-receptors, CXCR4 and CCR5, the virus infiltrates T cells and monocytes. The retrovirus uses reverse transcriptase to convert its RNA into DNA after attaching it to and entering the host cell. These newly replicated DNA copies then exit the host cell and infect other cells.15,40,41

HIV-1 is a retrovirus and belongs to a subset of retroviruses known as lentiviruses.38,42 Infection is the most common global health concern around the world.15 It has destroyed the millions of peoples health and continues to wreak havoc on the individual health of millions more. The pandemic of HIV-1 is the most devastating plague in the history of humans, as well as a significant challenge in the areas of medicine, public health, and biological science of research activities.34,43 Antiretroviral therapy is the only treatment that is commonly used. This is not a curative treatment; it must be used for the rest of ones life.15 Although antiretroviral therapy has reduced significantly HIV intensity and transmission, the virus has not been eradicated, and its continued presence can lead to additional health issues.44

Infection with the human immunodeficiency virus necessitates entry into target cells, such as through adhesion of the viral envelope to CD4 receptor sites.43 Cellular antiviral responses fail to eliminate the virus, resulting in a gradual depletion of CD4+ T cells and, finally, a severely compromised immune functioning system. Unfortunately, there is no cure for the virus that destroys immunity.4447 In advanced HIV infection, memory T-cell depletion primarily affects cellular and adaptive immune responses, with a minor impact on innate immune responses.48 Globally, 37.7 million people were living with HIV in 2020, and with 1.5 million individuals are infected with the virus.49 The advancement of stem cell therapy and the conduct of implemented clinical trials have revealed that stem cell treatment has high hopes for a range of medical conditions and implementations.15

Stem cell treatment has shown impressive outcomes in HIV management and has the potential to have significant implications for HIV treatment and prevention in the future. In HIV patients, stem cell therapy helps to suppress the viral load even while enabling antiretroviral regimens to be tapered. Interestingly, this practice led to a significant improvement in procedure outcomes soon after starting antiretroviral treatment.15 Stem cell transplantation can alleviate a wide variety of diseases that are currently incurable. They could also be used to create a novel anti-infection therapy strategic plan and to enhance the treatment of immunologic conditions such as HIV infection. HIV wreaks havoc on immune system cells.30,50

The virus infects and replicates within T-helper cells (T-cells), which are white immune system cells. T-cells are also referred to as CD4 cells. HIV weakens a persons immune system over time by pulverizing more CD4 cells and multiplying itself. More pertinently, if the individual has been unable to obtain anti-retroviral medicine, he will progressively fail to control the infectious disease and illnesses.3,15,42

Despite 36 years of scientific research, investigators are still trying to cure human HIV and its potential problem, AIDS.3,5153 HIV continues to face unconquerable dangers to human survival. This virus has developed the potential to avoid anti-retroviral therapy and tends to result in victim death.52 Investigators are still looking for effective and all-encompassing treatment for HIV and its complexity, AIDS.54 This massive amount of data revealed potential AIDS treatment targets.55 Thousands of research projects have yielded a great deal of information on the elusive AIDS life cycle to date.5456 These massive amounts of data supplied possible targets for AIDS treatment.33,55,56 In HIV-infected patients, using stem cell therapy can augment the process of keeping the viral load stagnant by permitting antiretroviral regimens to be tapered.15

Overall, stem cell-based strategies for HIV and AIDS treatment have recently emerged and have become a key area of research. Ideally, effective stem cell-based therapeutic approaches might have several benefits.30 Clinical studies encompassing stem cell therapy have shown substantial therapeutic effects in the treatment of various autoimmune, degenerative, and genetic problems.15,25 Substantial progress has been developed in the treatment of HIV infection using stem cell-based techniques.30

Successfully treated, clinical studies have shown that total tissue recovery is feasible.15,57 In the early 1980s, the first stem cell transplants were accomplished on HIV-positive patients who were unsure of their viral disease. Following the above preliminary aspects, many HIV-positive patients with concurrent malignant tumours or other hematologic disorders underwent allogeneic stem cell transplantation around the world.42 After ART became a common treatment option for patients,58,59 the procedures prognosis improved dramatically. In addition, a retrospective study of 111 HIV+ transplant patients demonstrated a mildly lower overall survivorship performance in comparison to an HIV-uninfected comparison group.60

Earlier, the primary problem for people living with HIV and AIDS was immunodeficiency caused by a loss of productive T-cells. Some clinicians intended to replenish lost lymphocytes through adoptive cell transplants in the initial days before efficacious antiretroviral therapy options were available. Immunologically, it is relatively simple in an isogeneic condition, as illustrated on HIV-positive individuals with just a correlating identical twin who received T-lymphocytes and stem cell transfusions to rebuild the weak immune status of the patient.60 Cell therapy transfusion may be used to remove resting virion genomes from CD4+ immune cells and macrophages mostly through genome-editing or cytotoxic anti-viral cells.15,60 Cell technology and stem cell biological reprogramming developments have made a significant contribution to novel strategies that may give confidence to HIV healing process.3 However, human embryonic stem cells can be distinguished into significant HIV target cells, according to several research findings.30,61,62

Initially, stem cell transplantation was believed to influence the clinical significance of HIV infection, but viral regulation was not accomplished in the discipline. Moreover, improvements in stem cell transplants utilizing synthetic or natural resistant cell resources, in combination with novel genetic manipulative tactics or the advancement of cytotoxic anti-HIV effector cells, have significantly accelerated this sector of HIV cell management.60 Multiple techniques are being introduced to overcome HIV, either through protecting cells from infectious disease or by continuing to increase immune responses to the viral infection.30 The various methods are as follows: Bone marrow stem cells Therapies, Autologous stem cell transplantations, Hematopoietic stem cell transplantation, Genetical modifications of Hematopoietic stem cells (HSCT), HSCT and HAART therapeutic approach, Human umbilical cord mesenchymal stem cell transplantation, Mesenchymal stem/stromal cells (MSCs) applications, CCR5 Delta32/Delta32 Stem-Cell Transplantation, CRISPR and stem cell applications, Induced Pluripotent Stem Cells applications.

According to the findings, circulating replicative HIV remains the most significant threat to effective AIDS therapy. As a result, a method for conferring resistance to circulating HIV particles is required. The effective viral burden in the human body would be significantly reduced if it were possible to defeat reproducing HIV particles.43,44 For the treatment of AIDS, a restorative approach that relies on bone marrow stem cells has been suggested.52 The proposed treatment method captures and eventually destroys circulating HIVs using receptor-integrated red blood cells. Red blood cell membranes can be equipped with the CD4 receptor and the C-C chemokine receptor type 5 and C-X-C chemokine receptor type 4 co-receptors, which will selectively bind circulating HIV particles.15,30,32,33,43,44,46,6365

The term autologous pertains to blood-forming stem cells obtained from the patient for use as a source of fresh blood cells followed by high-dose chemotherapeutic agents.66 Lymphoma is still the biggest cause of mortality in HIV patients. Autologous stem cell recovery or transplantation with high-dose treatments has long been supported as a treatment for certain types of cancer in HIV-negative patients, including leukaemia and lymphoma. Individuals over the age of 65, as well as those with health problems such as HIV, were excluded from initial transfusion experiments. Moreover, the treatment regimen mortality of transplantation has also been reduced significantly due to its use of peripheral blood stem cells rather than bone marrow and the use of newer marginal conditioning therapeutic strategies. HIV-infected clients may be able to utilize enough stem cells for an autologous transplant advancement in HIV management. High-dose Autologous stem cell transplant (ASCT) treatments are better than conventional treatment in people with relapsed non-Hodgkin lymphoma, according to randomized trial evidence. Similarly, studies on HIV-negative people with Hodgkin Lymphoma have shown that ASCT would provide patients with repetitive illness with long-term progression-free survival.66,67 Even so, the clinical trial on Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies report was explained as, the cell-associated HIV DNA and inducible infectious virus were not detectable in the blood of patients who attained complete chimerism.68

The study on long-term multilineage engraftment of autologous genome-edited hematopoietic stem cells in nonhuman primates report findings was Genome editing in hematopoietic stem and progenitor cells (HSPCs) is a potential innovative approach for the treatment of numerous human disorders. This report shows that genome-edited HSPCs engraft and contribute to multilineage repopulation following autologous transplantation in a clinically relevant large animal model, which is an important step toward developing stem cell-based genome-editing therapeutics for HIV and possibly other illnesses.69

Research on comprehensive virologic and immune interpretation in an HIV-infected participant again just after allogeneic transfusion and analytical interruption of antiretroviral treatment findings are the instance of HIV-1 cure having followed allogeneic stem cell transplantation (allo-SCT), resulting allo-SCTs in HIV-1 positive participants have failed to cure the disease. It describes adjustments in the HIV reservoir in a single chronically HIV-infected client who had undergone allo-SCT for acute lymphoblastic leukaemia treatment and was obtaining suppressive antiretroviral treatment.

To estimate the size of the HIV-1 reservoir and describe viral phylogenetic and phenotypic modifications in immune cells, the investigators just used leukapheresis to obtain peripheral blood mononuclear cells (PBMCs) from a 55-year-old man with chronic HIV infection prior and after allo-SCT. Once HIV-1 was found to be unrecognizable by numerous tests, including the PCR measurement techniques both of overall and fully integrated HIV-1 DNA, recompilation virus precise measurement by significant cell input quantifiable viral outgrowth assay, and in situ hybridization of intestine tissue, the client accepted to an analytic treatment interruption (ATI) with recurrent clinical observing on day 784 post-transplantation. He continued to remain aviremic off ART until ATI day 288, once a reduced virus rebound of 60 HIV-1 copies/mL resulted, which expanded to 1640 HIV-1 copies/mL five days later, urging ART reinitiation. Rebounding serum HIV-1 action sequences were phylogenetically distinguishable from pro-viral HIV-1 DNA discovered in circulating PBMCs before transplantation. It was indicated that allo-SCT tends to result in significant reductions in the magnitude of the HIV-1 reservoir and a >9-month ART-free cessation from HIV-1 multiplication.34

The Impact of HIV Infection on Transplant Outcomes after Autologous Peripheral Blood Stem Cell Transplantation: A Retrospective Study of Japanese Registry Data reported as ASCT is a successful treatment option for HIV-positive patients with non-Hodgkin lymphoma and multiple myeloma (MM). HIV infection was associated with an increased risk of overall mortality and relapse after ASCT for NHL in a study population.70

The procedure of delivering hematopoietic stem cells mostly through intravenous infusion to restore normal haematopoiesis or treat cancer is known as hematopoietic stem cell transplantation.71 There has recently been a rise in the desire to develop strategies for treating HIV/AIDS diseases employing human hematopoietic stem cells,30 along with this Hutter and Zaia were evaluated the background of Haematopoietic stem cell transplantation (HSCT) in HIV-infected individuals.42

Attempts to use HSCT as a technique for immunologic restoration in AIDS patients or as a therapeutic intervention for malignant tumours were initially insufficient. Regretfully, in the absence of sufficient ART, HSCT seemed to have no impact on the evolution of HIV infection, and the majority of the patients ended up dead of rapidly deteriorating immunosuppression or reoccurring lymphoma or leukaemia. A specific instance report described how an un-associated, matched donor supplied allogeneic HSCT to a patient with refractory lymphoma. The virus was unrecognizable by isolating or PCR of peripheral blood mononuclear cells commencing on day 32 after transplantation. Although HIV-1 was unrecognizable by cultural environment or PCR of several tissues examined at mortem, the patient died of recurring lymphoma on day 47. Another client who obtained both allogeneic HSCT and zidovudine had similar results, with HIV-1 becoming unnoticeable in the blood by PCR analysis. In some other particular instances, a 25-year-old woman with AIDS who obtained an allogeneic HSCT from a corresponding, unfamiliar donor after controlling with busulfan and cyclophosphamide and ART with zidovudine and IFN-2 regimen continued to live for 10 months before falling victim to adult respiratory distress. However, PCR testing of autopsy tissues revealed that they were HIV-1 negative.72

Recent research discovered significant progress towards the clinical application of stem cell-based HIV therapeutic interventions, principally illustrating the opportunity to effectively undertake a large-scale phase two HSC-based gene therapy experiment. In this investigation, the research team used autologous adult HSCs that had been transduced to a retroviral vector that usually contains a tat-vpr-specific anti-HIV ribozyme to develop cells that were less vulnerable to productive infection,73 whereas vector-containing cells have been discovered for extended periods (more than 100 weeks in most people) and CD4+ T cell gets counted were significantly high within anti-HIV ribozyme treating people group compared with the placebo group, the impacts on viral loads were minimal. The studys success, even so, is based on the realization that a stem cell-based strategy like this is being used as a more conventional and efficacious therapeutic approach.30 Some other latest clinical studies used a multi-pronged RNA-based strategic plan which included a CCR5-targeted ribozyme, an shRNA targeting tat/rev transcripts, and a TAR segment decoy.74

These crucial research findings are explained on lentiviral-based gene therapy vectors that can genetically manipulate both dividing and non-dividing HSCs and are less likely to cause cellular changes than murine retro-viral-based vectors. Long-term engraftment and multipotential haematopoiesis have been demonstrated in vector-containing and expressing cells, according to the researchers. Whereas the antiviral effectiveness was not reviewed, the results demonstrate the strategys protection, which helps to expand well for the possibility of a lentiviral-based approach in the upcoming years.30

A further approach, with a different emphasis, has been started up in the hopes of trying to direct immune function to target specific HIV to overcome barriers to attempting to clear the virus from the patient's body. These strategies use gene treatment innovations on peripheral blood cells to biologically modify cells so that they assert a receptor or chimeric particle that enables them to especially target a specific viral antigen,75 deception of HIV-infected peoples peripheral blood T cells raises issues to be addressed, such as the effects of ongoing HIV infection and ex vivo modification on the capabilities and lifetime of peripheral blood cells. Further to that, the above genetically manipulated cells would demonstrate their endogenous T cell receptors, and the representation of the newly introduced receptor could outcome in cross-receptor pairing, resulting in self-reactive T cells. Most of these deficiencies could be countered by enabling specific developmental strategies to take place that can start generating huge numbers of HIV-specific cells in a renewable, consistent way that can restore defective natural immune activity against HIV.30

One strategy being recognized is the application of B cells obtained from HSCs to demonstrate anti-HIV neutralizing specific antibodies. While animal studies have shown that neutralizing antibodies could protect against infection, and extensively neutralizing antibodies have been noticed in some HIV-infected persons, safety from a single engineered antibody might be exceptional.76,77 Realizing antibody binding and virus neutralization may assist in the development of chimeric receptors or single-chain therapeutic antibodies with recognition domains for other techniques that identify cellular immunity against HIV-infected cells.78,79 Thereby, genetically modifying HSCs to generate B cells that produce neutralizing anti-HIV specific antibodies, or engineering HSCs to enable multipotential haematopoiesis of cells that express a chimeric cellular receptor usually contains an antibody recognition domain, indicate one arm of an HSC-based engineered immunity process.30

A further technique of using HSCs that were genetically altered with molecularly cloned T-cell receptors or chimeric molecules particular to HIV to yield antigen-specific T cells. The basic difference in this strategy is that the cells produced from HSCs after standard advancement in the bone marrow and thymus are made subject to normal central tolerance modalities and are antigen-specific naive cells, and therefore do not have the ex-vivo manipulation and impaired functioning or exhaustion problems that other external cell modification methods would have. In this context, the latest actual evidence research using a molecularly cloned T cell receptor particular to an HIV-1 Gag epitope in the aspect of HLA-A*0201 revealed that HSC altered in this ability can progress into fully functioning, mature HIV specialized CD8+ T cells in human thymic tissue that conveys the acceptable constrained HLA-A*0201 particles.80 This explores the possibility of genetically engineering HSCs with a molecularly cloned receptor and signifies a step toward a better understanding and application of initiated T cell responses, which would probably result in the eradication of HIV infection from the body, similar to the natural immune function of other virus infections and pathogenic organisms.30

In an allogeneic transplantation, donor stem cells replace the patients cells.66 Allogeneic hematopoietic stem cell transplantation (HSCT) has appeared as one of the most potent treatment possibilities for many people who suffer from hemopoietic system carcinomas and non-malignant ailments.81 Both HIV-cured people have received HSCT utilizing CCR5 132 donor cells.82,83 This implies that HIV eradication necessitates a decrease in the viral reservoir through the myeloablative procedures,8486 Having followed that, immune rebuilding with HIV-resistant cells was carried out to prevent re-infection.45 The possibility of adoptive transfer of ex vivo-grown, virus-specific T-cells to prevent and control infectious diseases (eg, Cytomegalovirus and EBV) in immunocompromised patients helps to make adoptive T-cell treatment a feasible strategy to inhibit HIV rebound having followed HSCT.81,87,88

The Engineered Zinc Finger Protein Targeting 2LTR Inhibits HIV Integration in Hematopoietic Stem and Progenitor Cell-Derived Macrophages: In Vitro Study, the researchers investigated the efficacy and safety of 2LTRZFP in human CD34+ HSPCs. Researchers used a lentiviral vector to transduce 2LTRZFP with the mCherry tag (2LTRZFPmCherry) into human CD34+ HSPCs. The study findings suggest that the anti-HIV-1 integrase scaffold is an enticing antiviral molecule that could be utilised in human CD34+ HSPC-based gene therapy for AIDS patients.89

The fundamental element of HIV management is stem cell genetic modification, which involves genetically enhanced patient-derived stem cells to overcome HIV infection. In this sector, numerous experimental studies, in vitro as well as in vivo examinations, and positive outcomes for AIDS patients have been conducted.65,74 Genetic engineering for HIV-infected individuals can provide a once-only intervention that minimizes viral load, restores the immune system, and minimizes the accumulated toxicities concerned with highly active antiretroviral therapy (HAART).73 HSCs can be genetically altered, permitting for the addition of exogenous components to the progeny that protects them from direct infectious disease and/or enables them to target a specific antigen. Besides that, HSC-based strategies can enhance multilineage hemopoietic advancement by re-establishing several arms of the immune function. Eventually, as HSCs can be produced autologously, immunologic tolerance is typically high, enabling effective engraftment and subsequent distinction into the fully functioning mature hematopoietic cells.30

The utilization of human HSCs to rebuild the immune function in HIV disease is one application that tries to preserve newly formed cells from HIV infection, while another attempts to develop immune cells that attack HIV infected cells. While each initiative has many different aspects at the moment, they represent huge attention to HIV/AIDS therapies that, most likely when integrated with the other therapeutic approaches, would result in the body trying to overcome the obstacles needed for the virus to be effectively cleaned up.30

While HSC transplantation technique and processes are not accurately novel, as they are commonly and effectively used to address a wide variety of haematological diseases and malignant neoplasms,90 trying to combine them with a gene therapeutic strategy represents a unique and possibly potent therapeutic approach for HIV and AIDS-related ailments. As the results of HIV-infected patients who obtained autologous HSCT continued to improve, there was growing interest in genetically altered stem cells that were tolerant to HIV disease. Multiple logistical challenges have impeded the advancement of genetically modified hematopoietic stem cells as a conceivable therapeutic option for HIV/AIDS.72,73

UCLAs Eli and Edythe Broad Center for Restorative Medicine and Stem Cell Studies is one bit closer to constructing an instrument to arm the bodys immune system to attack and defeat HIV. Dr. Kitchen et al are the first ones to disclose the use of a chimeric antigen receptor (CAR), a genetically manipulated molecule, in blood-forming stem cells. In the experiment, the research team introduced a CAR gene into blood-forming stem cells, which were then moved into HIV-infected mice that had been genetically programmed. The scientists found that CAR-carrying blood stem cells efficiently transformed into fully functioning T cells that have the ability to kill HIV-infected cells in mice. The outcome was an 80-to-95 percentage reduction in HIV levels, suggesting that stem-cell-based genetic engineering with a CAR might be a viable and effective approach for treating HIV infection among humans. The CAR initiative, according to Dr. Kitchen, is much more able to adapt and ultimately more efficient, which can conceivably be used by others. If any further experiment showcases keep promising, the scientists expect that a practice based on their strategy will be accessible for clinical development within the next 510 years.91

HSCT and HAART therapeutic approaches in treating HIV/AIDS as the emergence of highly active antiretroviral therapy (HAART) in the 1990s improved survival rates of HIV infection, leading to a major dramatic drop in the occurrence of AIDS and AIDS-related mortalities. As an outcome, there is much less involvement with using HSCT as a therapy for HIV infection.28,33,43,67,86

A randomized clinical trial of human umbilical cord mesenchymal stem cell transplant among HIV/AIDS immunological non responders investigation, the researchers examined the clinical efficacy of transfusion of human umbilical cord mesenchymal stem cells (hUC-MSC) for immunological non-responder clients with long-term HIV disease who have an unmet medical need in the aspect of effective antiretroviral therapy. From May 2013 to March 2016, 72 HIV-infected participants were admitted in this stage of the randomized, double-blind, multi-center, placebo-controlled dose-determination investigation. They were either given a high dose of hUC-MSC of 1.5106/kg body weight as well as small doses of hUC-MSC of 0.5106/kg body weight, or a placebo application. During the 96-week follow-up experiment, interventional and immunological character traits were analysed. They found that hUC-MSC therapy was both safe and efficacious among humans. There was a significant rise in CD4+ T counts after 48 weeks of treatment in both the high-dose (P 0.001) and low-dose (P 0.001) groups, but no changes in the comparison group.92

One interesting invention made by a team of UC Davis investigators is the recognition of a particular form of stem cell that can minimize the quantity of the virus that tends to cause AIDS, thus dramatically increasing the bodys antiviral immune activity. Mesenchymal stem/stromal cells (MSCs) furnish an incredible opportunity for a creative and innovative, multi-pronged HIV cure strategic plan by augmenting prevailing HIV potential treatments. Even while no antivirals have been used, MSCs have been able to increase the hosts antiviral responses. MSC therapeutic approaches require specialized delivery systems and good cell quality regulation. The studys findings lay the proper scientific foundation for future research into MSC in the ongoing treatment of HIV and other contagious diseases in the clinical organization.35

Infection with HIV-1 necessitates the existence of both specific receptors and a chemokine receptor, particularly chemokine receptor 5 (CCR5).46 Resistance to HIV-1 infection is attained by homozygozygozity for a 32-bp removal in the CCR5 allele.93 In this investigation, stem cells were transplanted in a patient with severe myeloid leukaemia and HIV-1 infection from a donor who was homozygous to Chemokine receptor 5 delta 32. The client seemed to have no viral relapses after 20 months of transplantation and attempting to stop antiretroviral medicine. This finding highlights the essential role that CCR5 tries to play in HIV-1 infection maintenance.86

In comparison, additional HIV-1-infected people who have received allogeneic stem cell transplants with cells from CCR5 truly wild donors did not have long-term relapses from HIV-1 rebound, with 2 of these patients trying to report viral reoccurrence 12 as well as 32 weeks after analytic treatment interruption, respectively. Among these 2 patients, allogeneic stem cell transplantation probably reduced but did not eliminate latently HIV-infected cells, enabling persistent viral reservoirs to activate viral rebound. This viewpoint may not rule out the potential that allogeneic hematopoietic stem cell transplantation might result in a much more comprehensive or near-complete elimination of viral reservoirs, enabling long-term drug-free relapse of HIV-1 infection in some contexts.84 As just one report demonstrated a decade earlier, a curative treatment for HIV-1 remained elusive. The Berlin Patient has undergone 2 allogeneic hematopoietic stem cell transplantations to cure his acute myeloid leukaemia utilizing a potential donor with a homozygous genetic mutation in HIV coreceptor CCR5 (CCR532/32).15,34,46,64,65,72,82,84,86,9496 Other similar studies with CCR5 receptor targets are as follows: Automated production of CCR5-negative CD4+-T cells in a GMP compatible, clinical scale for treatment of HIV-positive patients,97 Mechanistic Models Predict Efficacy of CCR5-Deficient Stem Cell Transplants in HIV Patient Populations,98 Conditional suicidal gene with CCR5 knockout.99

Clustered regularly interspaced short palindromic repeats CRISPR/Cas9 is a promising gene editing approach that can edit genes for gain-of-function or loss-of-function mutations in order to address genetic abnormalities. Despite the fact that other gene editing techniques exist, CRISPR/Cas9 is the most reliable and efficient proven method for gene rectification.100103

Genome engineering employing CRISPR/Cas has proven to be a strong method for quickly and accurately changing specific genomic sequences. The rise of innovative haematopoiesis research tools to examine the complexity of hematopoietic stem cell (HSC) biology has been fuelled by considerable advancements in CRISPR technology over the last five years. High-throughput CRISPR screenings using many new flavours of Cas and sequential and/or functional outcomes, in specific, have become more effective and practical.104,105

The power of the CRISPR/Cas system is that it can specifically and efficiently target sequences in the genome with just a single synthetic guide RNA (sgRNA) and a single protein. Cas9 is directed to the specific DNA sequence by the sgRNA, which causes double stranded breaks and activates the cells DNA repair processes. Non-homologous end joining can cause insertiondeletion (indel) substitutions at the target location, whereas homology-directed repair can use a template DNA to insert new genetic material.104,106

The possibility for CRISPR/Cas9 to be used in the hematopoietic system was emphasised as pretty shortly after it was initiated as a new genome editing method.106,107 The efficiency with which CRISPR-mediated alteration can be used to evaluate hematopoietic stem/progenitor and mature cell function via transplantation. As a result, hematopoietic research has significantly advanced with the implementation of these technologies. Whilst single-gene CRISPR/Cas9 programming is a significant tool for testing gene function in primary hematopoietic cells, high-throughput screenings potentially offer CRISPR/Cas9 an even greater advantage in hematopoietic research.104

While understanding human haematological disorders requires the ability to mimic diseases, the ultimate goal is to transfer this innovation into therapies. Despite significant advancements in CRISPR technology, there are still barriers to overcome before CRISPR/Cas9 can be used effectively and safely in humans. CRISPR has also been used to target CCR5 in CD34+ HSPCs in an effort to make immune cells resistant to HIV infection, as CCR5 is an important coreceptor for HIV infection.104

CRISPR is a modern genome editing technique that could be used to treat immunological illnesses including HIV. The utilization of CRISPR in stem cells for HIV-related investigation, on the other end, was ineffective, and much of the experiment was done in vivo. The new research idea is about increasing CRISPR-editing efficiencies in stem cell transplantation for HIV treatment, as well as its future perspective. The possible genes that enhance HIV resistance and stem cell engraftment should be explored more in the future studies. To strengthen HIV therapy or resistance, double knockout and knock-in approaches must be used to build a positive engraftment. In the future, CRISPR/SaCas9 and Ribonucleoprotein (RNP) administration should be explored in the further investigations.108 As well as some different title studies were explained the effectiveness of the CRISPR gene editing technology on the management of HIV/AIDS including: CRISPR view of hematopoietic stem cells: Moving innovative bioengineering into the clinic,104 CRISPR-Edited Stem Cells in a Patient with HIV and Acute Lymphocytic Leukaemia,109 Sequential LASER ART and CRISPR Treatments Eliminate HIV-1 in a Subset of Infected Humanized Mice,110 Extinction of all infectious HIV in cell culture by the CRISPR-Cas12a system with only a single crRNA,111 HIV-specific humoral immune responses by CRISPR/Cas9-edited B cells,112 CRISPR-Cas9 Mediated Exonic Disruption for HIV-1 Elimination,113 RNA-directed gene editing specifically eradicates latent and prevents new HIV-1 infection,114 CRISPR/Cas9 Ablation of Integrated HIV-1 Accumulates Pro viral DNA Circles with Reformed Long Terminal Repeats,115 CRISPR-Cas9-mediated gene disruption of HIV-1 co-receptors confers broad resistance to infection in human T cells and humanized mice,116 Inhibition of HIV-1 infection of primary CD4+ T-cells by gene editing of CCR5 using adenovirus-delivered CRISPR/Cas9,117 Transient CRISPR-Cas Treatment Can Prevent Reactivation of HIV-1 Replication in a Latently Infected T-Cell Line,118 CCR5 Gene Disruption via Lentiviral Vectors Expressing Cas9 and Single Guided RNA Renders Cells Resistant to HIV-1 Infection,119 CRISPR/Cas9-Mediated CCR5 Ablation in Human Hematopoietic Stem/Progenitor Cells Confers HIV-1 Resistance In Vivo.109

Induced pluripotent stem cells (iPSCs) have significantly advanced the field of regenerative medicine by allowing the generation of patient-specific pluripotent stem cells from adult individuals. The progress of iPSCs for HIV treatment has the potential to generate a continuous supply of therapeutic cells for transplantation into HIV-infected patients. The title of the study is reported on Generation of HIV-1 Resistant and Functional Macrophages from Hematopoietic Stem Cellderived Induced Pluripotent Stem Cells. In this investigation, researchers used human hematopoietic stem cells (HSCs) to produce anti-HIV gene expressing iPSCs for HIV gene therapy. HSCs were dedifferentiated into constantly growing iPSC lines using 4 reprogramming factors and a combination anti-HIV lentiviral vector comprising a CCR5 shRNA and a human/rhesus chimeric TRIM5 gene. After directing the anti-HIV iPSCs toward the hematopoietic lineage, a large number of colony-forming CD133+ HSCs were acquired. These cells were distinguished further into functional end-stage macrophages with a normal phenotypic profile. Upon viral challenge, the anti-HIV iPSC-derived macrophages displayed good protection against HIV-1 infection. Researchers have clearly shown how iPSCs can establish into HIV-1 resistant immune cells and explain their prospective use in HIV gene and cellular therapies.120

Some other similar titles of the studies reported on the effectiveness of IPSCs on HIV/AIDS managements are as follows: Generation of HIV-Resistant Macrophages from IPSCs by Using Transcriptional Gene Silencing and Promoter-Targeted RNA,121 Generation of HIV-1-infected patients gene-edited induced pluripotent stem cells using feeder-free culture conditions,122 A High-Throughput Method as a Diagnostic Tool for HIV Detection in Patient-Specific Induced Pluripotent Stem Cells Generated by Different Reprogramming Methods,123 Genetically edited CD34+ cells derived from human iPS cells in vivo but not in vitro engraft and differentiate into HIV-resistant cells,124 Engineered induced-pluripotent stem cell-derived monocyte extracellular vesicles alter inflammation in HIV humanized mice,125 Sustainable Antiviral Efficacy of Rejuvenated HIV-Specific Cytotoxic T Lymphocytes Generated from Induced Pluripotent Stem Cells.126

Recently, one HIV patient appeared to be virus-free after having undergone a stem-cell transfusion in which their WBCs were changed with HIV-resistant variations.84 Timothy Ray Brown also noted as the Berlin patient, who is still virus-free, was the first individual to undertake stem-cell transplantation a decade earlier. The most recent patient, like Brown, had a type of leukaemia that was vulnerable to chemo treatments. They required a bone marrow transplantation, which involved removing their blood cells and replacing them with stem cells from a donor cell.5,31,34,41,127130 Rather than simply choosing a suitable donor, Ravindra Gupta et al chose one who already had 2 copies of a mutant within the CCR5 gene,128,131 which provides resistance to HIV infection.3

Additionally, this gene encodes for a specific receptor of white blood cells that are assisted in the bodys immunological responses. The transplant, according to Guptas team, completely replaced the clients White cells with HIV-resistant forms.41,83 Cells in the patients blood disrupted expressing the CCR5 receptor, making it unfeasible for the clients form of HIV to infect the above cells again. The scientists determined that the virus had been cleared from the patients blood after the transplantation. Besides that, after 16 months, the client has withdrawn antiretroviral treatment. The infection was not detected in the most recent follow-up, which occurred 18 months after the treatment was discontinued. Adam, also known as the London patient, was the second person to be cured of HIV as a result of a stem cell transfusion. This discovery is an important step forward in HIV research because it may aid in the detection of potential future therapeutic interventions. It must be noted, but even so, that this is not an extensively used HIV treatment. For HIV-infected patients, antiretroviral drugs have been the foremost therapeutic option.3,31,41,94,129,130 It also encourages many investigators and clinicians to look at the use of stem cells in the treatment of a wide range of serious medical conditions. The reprogramming abilities of stem cells, as well as their accessibility, have created a window of opportunity in medical research. The clinical utility of stem cells is forecast to expand rapidly in the coming years.

On Feb 15, 2022, scientific researchers confirmed that a woman had become the 3rd person in history to be successfully treated for HIV, the virus that causes AIDS, after just receiving a stem-cell transfusion that has used cells from cord blood. Within those transplant recipients, adult hematopoietic stem cells have been used; these are stem cells that eventually develop into all blood cell types, which include white blood cells, these are a vital component of the immune framework. Even so, the woman who had fairly recently been completely cured of HIV infection had a more unique experience than that of the 2 men who were actually cured before her.132

The clients physician, Dr. JingMei Hsu of Weill Cornell Medicine in New York, informed them that, she had been discharged from the hospital just 17 days after her procedure was performed, even with no indications of graft vs host ailment. The woman was HIV-positive but also had acute myeloid leukaemia, a blood cancer of the bone marrow that affects blood-forming cells. She had likely received cord blood as a successful treatment for both her cancer and HIV once her doctors decided on a potential donor well with HIV-blocking gene mutation. Cord blood comprises a high accumulation of hematopoietic stem cells; the blood is obtained during a childs birth and donated by the parents.132

The patients donor was partly nearly matched, and she received stem cells from a close family member to enhance her immune function after the transfusion. The procedure was performed on the woman in August of 2017. She chose to discontinue taking antiretroviral drugs, the standardized HIV intervention, 37 months upon her transfusion. After more than 14 months, there is no evidence of the viral infection or antibodies against it in her blood. Umbilical cord blood, in reality, is much more commonly accessible and simpler to try to match to beneficiaries than bone marrow. Perhaps, some research suggests that the method could be more available to HIV patients than bone marrow transplantation. Nearly 38 million people worldwide are infected with HIV. The potential for using partly matched umbilical cord blood transplantation increases the chances of choosing appropriate suitable donors for these clients considerably.132

It is really exciting to see the earlier terminally ill diseases of being effectively treated. In recent times, there has been a surge of focus on stem cell research.3 Stem cell therapy advancements in inpatient care are receiving a growing amount of attention.20 HIV/AIDS has been and remains a significant health concern around the world. Effective control of the HIV pandemic will necessitate a thorough understanding of the viruss transmission.32

Despite concerns about full compliance and adverse reactions, HAART has demonstrated to be able to succeed and is a sign specifically targeted form of treatment against HIV advancement. As illustrated by the first case of HIV infection relapse attained by bone marrow transplant, anti-HIV HPSC-based stem cell treatment and genotype technology have established a possible future upcoming technique to try to combat HIV/AIDS.

Investigators have conducted experiments with engineering distinct anti-HIV genetic traits trying to target different phases of HIV infection utilizing advanced scientific modalities. In numerous in vivo and in vitro animal studies, HSPCs and successive mature cells were secured from HIV infection by trying to target genetic factors in the infection. Anti-HIV gene engineering of HSPCs is safe and efficacious.15

The number of stem-cell-based research trials has risen in recent years. Thousands of studies claiming to use stem cells in experimental therapies have been registered worldwide. Despite some promising results, the majority of clinical stem cell technologies are still in their early life. These achievements have drawn attention to the possibility of the potential and advancement of various promising stem cell treatments currently in development.11

HIV remains a major danger to humanity. This virus has developed the ability to evade antiretroviral medication, resulting in the death of individuals. Scientists are constantly looking for a treatment for HIV/AIDS that is both effective and efficient.52 The 1st treatments in HIV+ clients were conducted in the early 1980s, even though they were cognizant of their viral disease. Following these early cases, allogeneic SCT was used to treat HIV+ patients with associated cancer or other haematological disorders all over the world. Stem cell transplantation developments have also stimulated the improvement of innovative HIV therapeutic approaches, especially for large goals like eradication and relapse.60

Numerous stem cell therapy progressions have been recognized with autologous and allogeneic hematopoietic stem cell transplantation, as well as umbilical cord blood mesenchymal stem cell transplant in AIDS immunologic non-responders. Whereas this sector continues to advance and distinguishing directives for these cells become much more effective, totipotent stem cells such as hESC and the recently reported induced pluripotent stem cells (iPSC) could be very useful for genetic engineering methods to counter hematopoietic abnormalities such as HIV disease.133135

Immunocompromised people are at a higher risk of catching life-threatening diseases. The perseverance of latently infected cells, which is formed by viral genome inclusion into host cell chromosomes, is a significant challenge in HIV-1 elimination. Stem cell therapy is producing impressive patient outcomes, illustrating not only the broad relevance of these strategies but also the huge potential of cell and gene treatment using adult stem cells and somatic derivative products of pluripotent stem cells (PSCs).

Stem cells have enormous regeneration capacity, and a plethora of interesting therapeutic uses are on the frontier. This is a highly interdisciplinary scientific field. Evolutionary biologists, biological technicians, mechanical engineers, and others that have evolved novel concepts and decided to bring them to medical applications are required to make important contributions. Further to that, recent advancements in several different research areas may contribute to stem cell application forms that are novel. Several hurdles must be conquered, however, in the advancement of stem cells. On the other hand, this discipline appears to be a promising and rapidly expanding research area.

Stem cell-based approaches to HIV treatment resemble an innovative approach to trying to rebuild the ravaged bodys immune system with the utmost goal of eliminating the virus from the body. We will probably see effective experiments from the next new generation of stem cell-based strategies shortly, which will start serving as a base for the further development and use of these techniques in a range of treatment application areas for other chronic diseases.

My immense pleasure was mentioned to family members and friends, who supported and encouraged me in every activity.

There was no funding for this work.

The authors declare that they have no conflicts of interest in relation to this work.

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