Archive for the ‘Bone Marrow Stem Cells’ Category

March 20, 2017 by Melissa Gaskill Cultured stem cells. Credit: BioServe Inc., University of Colorado

Growing significant numbers of human stem cells in a short time could lead to new treatments for stroke and other diseases. Scientists are sending stem cells to the International Space Station to test whether these cells proliferate faster in microgravity without suffering any side effects.

Therapeutic uses require hundreds of millions of stem cells and currently no efficient way exists to produce such quantities. Previous research suggests that microgravity could help, and the space station is home to the nation's only national lab in microgravity.

Some types of stem cells grow faster in simulated microgravity, according to Abba Zubair, a researcher at the Mayo Clinic in Jacksonville, Florida. Zubair is principal investigator for the Microgravity Expanded Stem Cells investigation, which is cultivating human stem cells aboard the space station for use in clinical trials back on Earth. He holds a doctor of medicine degree in transfusion medicine and cell therapy and a doctorate of philosophy in tumor immunology.

Human stem cells are cells that have not yet specialized in function and can divide into a spectrum of cell types, rejuvenating and repairing tissue throughout a person's lifetime. Stem cells in every organ of the body, including skin and bones, maintain those organs and repair tissue by dividing and differentiating into specialized cells.

Harvesting a person's stem cells and growing enough of them for use in therapies has proven difficult, though. Researchers have successfully grown mesenchymal stem cells, found in bone marrow, but growing sufficient quantities takes weeks. That could be too late for treatment of some conditions.

"Stem cells are inherently designed to remain at a constant number," Zubair explains. "We need to grow them faster, but without changing their characteristics."

The first phase of the investigation, he adds, is answering the question: "Do stem cells grow faster in space and can we grow them in such a manner that they are safe to use in patients?"

Investigators will examine the space-grown cells in an effort to understand the mechanism behind microgravity's effects on them. The long-term goal is to learn how to mimic those effects and develop a safe and reliable way to produce stem cells in the quantities needed.

The second phase will involve testing clinical application of the cells in patients. Zubair has been studying treatment of stroke patients with lab-grown stem cells and plans to compare those results with use of the space-grown stem cells.

"What is unique about this investigation is that we are not only looking at the biology of the cells and how they grow, but focusing on application, how we can use them to treat patients," he says.

The investigation expands existing knowledge of how microgravity affects stem cell growth and differentiation as well as advances future studies on how to produce large numbers of stem cells for treating stroke and other conditions.

The faster that happens, the better for those who could benefit from stem cell therapies.

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Stem cells seem speedier in space - Phys.Org

The study consists of donor and patient pairs for allogeneic hematopoietic cell transplantation. The first part of the study, which is nearing completion, is intended to enroll an initial cohort of 10 donor and recipient pairs, consisting of patients with advanced hematological malignancies and their HLA-matched sibling donors. Interim results show that a single injection of BL-8040 mobilized sufficient amounts of cells required for transplantation at a level of efficacy similar to that achieved by using 4-6 injections of G-CSF, the current standard of care. Furthermore, all recipients transplanted so far have experienced a successful neutrophil engraftment. The recipients will be followed for one year to assess acute and chronic GVHD events. As for the donors, BL-8040 treatment was safe and well tolerated.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "We are very encouraged by these initial results of the Phase 2 clinical trial for assessing BL-8040, our lead oncology and hematology platform, as a single agent for hematopoietic stem cell mobilization for allogeneic transplantation. Hematopoietic stem cells are increasingly used as part of the treatment regimen for certain types of hematological cancers, as well as for severe anemia and immune deficiency disorders. These results, supporting BL-8040 as a one-day dosing and up-to-two-day collection regimen, for rapid mobilization of substantial amounts of stem cells, represent a significant improvement over the current standard of care, which requires four-to-six daily injections of G-CSF and one-to-four apheresis sessions.If there are no safety concerns regarding graft failure or rejection after the interim safety review of donor-recipient pairs participating in Part 1 of the study, we will continue with Part 2 of the study, which will permit enrollment of recipients with either matched sibling or haploidentical donors, up to a total enrollment in the study of 24 donor-recipient pairs. We are looking forward to the topline results expected by the end of 2017."

"We continue our efforts to maximize the potential of our unique BL-8040 oncology platform, with multiple clinical studies for additional indications up and running or expected to start in 2017, including several combination studies with immune checkpoint inhibitors and a registration study in stem-cell mobilization for autologous transplantation," added Mr. Serlin.

The Phase 2 open-label study is conducted in collaboration with the Washington University School of Medicine, Division of Oncology, and will enroll up to 24 donor/recipient pairs, aged 18-70. The trial is designed to evaluate the ability of BL-8040, as a single agent, to promote stem cell mobilization for allogeneic hematopoietic cell transplantation. On the donor side, the primary endpoint of the study is the ability of a single injection of BL-8040 to mobilize sufficient amounts of cells for transplantation following up to two apheresis procedures. On the recipient side, the study aims to evaluate the time to engraftment rate following transplantation of the BL-8040 collected graft.

The study will also evaluate the safety and tolerability of BL-8040 in healthy donors, as well as graft durability, the incidence of grade 2-4 acute and chronic GVHD, and other recipient related parameters in patients who have undergone transplantation of hematopoietic cells mobilized with BL-8040.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About Stem Cell Mobilization

High-dose chemotherapy followed by hematopoietic cell transplantation has become an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, as well as various forms of lymphoma and leukemia. Modern peripheral stem-cell harvesting often replaces the use of traditional surgical bone marrow stem-cell harvesting. In the modern method, stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), often with the addition of a mobilizing agent such as Plerixafor (Mozobil), harvested from the donor's peripheral blood by apheresis, and infused to the patient after chemotherapy ablation treatment.

An allogeneic hematopoietic cell transplant involves matching a patient's tissue type, specifically their human leukocyte antigen (HLA) tissue type, with that of a related or unrelated donor. HLA proteins are found on all cells of our body and are the main way the immune system tells the difference between our own cells and foreign cells. The closer the HLA match between a donor and recipient, the greater the chance a transplant will be successful. If the HLA match is not close enough, the donor's immune system, which accompanies the donated stem cells, recognizes the HLA mismatch, and will attack the recipient's tissues. This process is known as graft versus host disease (GVHD).

Approximately 70% of people with a hematological malignancy or bone marrow failure syndrome who need an allogeneic transplant have an HLA-identical sibling or unrelated donor available. For patients who need a stem cell transplant but do not have an HLA-matched related or unrelated donor, recent medical advances have made possible the use of a partially matched or haploidentical related donor. A haploidentical related donor is usually a 50% match to the recipient and may be the recipient's parent, sibling or child.

The advantage of having a haploidentical transplant is thatit increases the chance offinding a donoras almost everyone has at least one haploidentical relative. Relatives can usually be asked to donate stem cells much more quickly than unrelated volunteer donors, particularly when the volunteer donors live in other countries, thereby allowing transplants to be done in a more timely manner.

With improvements in medical treatment, complications of a haploidentical transplant, such as GVHD, rejection of the graft and slow recovery of the immune system appear not to be increased compared to transplants using HLA-matched related or unrelated donors. Since this is a relatively new approach to stem cell transplantation, a haploidentical transplant is a treatment option that is not offered at all treatment centers, but is becoming more common.

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML and is in the midst of a Phase 2b study as an AML consolidation treatment and a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada), on the basis of which the Company has initiated a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck's KEYTRUDA; and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.

For additional information on BioLineRx, please visit the Company's website athttp://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated onFacebook,Twitter, andLinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2016. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts: PCG Advisory Vivian Cervantes Investor Relations +1-212-554-5482 vivian@pcgadvisory.com

or

Tsipi Haitovsky Public Relations +972-52-989892 tsipihai5@gmail.com

SOURCE BioLineRx Ltd.

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BioLineRx Provides Update on Phase 2 Open-Label Study for BL-8040 as Novel Stem Cell Mobilization Treatment - PR Newswire (press release)

Tri-City Herald

Retired Richland sergeant battling rare blood disease, awaiting marrow transplant Tri-City Herald People who are healthy, between 18 and 44, and want to register as a bone marrow/stem cell donor can do it at join.bethematch.org/hope4sarge or join.bethematch.org/hopeforsarge. A swab kit will be mailed to their home with instructions and a confirmation.

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Retired Richland sergeant battling rare blood disease, awaiting marrow transplant - Tri-City Herald

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Cesca Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced the publication in a peer reviewed journal of data from its Critical Limb Ischemia (CLI) feasibility study utilizing the Companys innovative point-of-care technology. The report was published in the Stem Cells International and is available online at https://www.hindawi.com/journals/sci/2017/4137626/ref/.

Results from the seventeen patient clinical study titled, Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System, (the Study) were obtained using Cescas automated point-of-care technology. The single treatment procedure was performed at the patients bedside and took less than 60 minutes. The Study results showed significant improvement in wound healing, rest pain and six-minute walking distance, along with significant reduction in intermittent claudication pain following the treatment.

Dr. Venkatesh Ponemone, Study Director and Executive Director of TotipotentRX, a Cesca subsidiary and the corresponding author of the article commented, We are targeting difficult to treat or life threatening conditions such as CLI with our autologous, cell-based therapies. We believe our innovative point-of-care cell processing systems, such as those used in the Study, can play an important role in optimizing the quality and quantity of target cells used to improve patient outcomes.

Dr. Xiaochun "Chris" Xu, Cesca's Interim CEO added, We are pleased that the Study was recognized and published in a peer reviewed journal. The encouraging data highlights Cescas capability to develop effective automated cellular processing systems. We welcome strategic partners to help us further refine their use in larger clinical settings.

About Cesca Therapeutics Inc.Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. These include:

Forward-Looking StatementThe statements contained herein may include statements of future expectations and other forward-looking statements that are based on managements current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

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Cesca Therapeutics (KOOL) Announces CLI Feasibility Study Published in Stem Cells International - StreetInsider.com

By FPJ Bureau|Mar 19, 2017 12:05 am

Mumbai : A Bone Marrow Transplant (BMT) and Birthing Centre was launched by actor Shah Rukh Khan on Friday at Nanavati Super Speciality Hospital (NSSH) at Vile Parle. On the occasion, Khan told the people present to take their medicines on timeand do regular check ups and get rid of ailments.

BMT is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells. Bone marrow is the soft, fatty tissue inside our bones which produces blood cells. Stem cells are immature cells in the bone marrow that give rise to different blood cells.

Dr Nimish Kulkarni, Associate Consultant of BMT, said, BMT are considered the last-mile treatment solutions for patients with blood and cancer disorders. We specialise in providing transplant services for benign hematological disorders like Thalassemia, Sickle cell disease, Aplastic anemia, bleeding disorders and coagulation disorders. Shah Rukh said, I have been associated with Nanavati Hospital before 25 years ago as a patient. Every year more than 10,000 people are dying of cancer in India, even my parents succumbed to cancer. I am glad now we have a world class treatment.

Dr. Ali has looked after me and my various injuries. He has looked after my sister and wife too. Few people know that when my third son, Abram, was born, he was in a very critical condition. He was rushed to the Paediatric centre here and looked after even before we could meet him. Its a strange cycle that my child was saved in the same hospital which has a ward named after my mother. I am thankful to them, Khan added. Kulkarni added, The specialisation also extends to providing advanced transplant treatments for malignant hematological disorders like acute and chronic leukemia, Hodgkins and Non-Hodgkins Lymphoma, Multiple Myeloma, Myelodysplasia,

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SRK launches BMT, Birthing Centre at Nanavati hospital - Free Press Journal

Windsor Star

Prayers, hopes for Madalayna, as brother donates life-saving stem cells Windsor Star When Tamara was interviewed on Friday, she and husband Charles were waiting while Henrik was donating his bone marrow a 3-hour procedure called harvesting. Madalayna was on Tamara's lap, waiting for the ... bone marrow registrations in Madalayna's ... Transplant day arrives for Windsor babyCTV News all 3 news articles »

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Prayers, hopes for Madalayna, as brother donates life-saving stem cells - Windsor Star

I just read a concerning paper about an experimental stem cell treatment for children with autism.

The authors are Himanshu Bansal and colleagues of India. The senior author, Prasad S Koka, is the Editor-in-Chief of the Journal of Stem Cells where the paper appeared, which raises questions about whether the manuscript received a thorough peer review. Koka is actually an author on all five of the research papers published in that issue of the journal. But thats a minor issue compared to the content of the paper.

Bansal et al. describe a procedure in which they extracted fluid from the bone marrow of each child. This fluid (bone marrow aspirate) was treated in the laboratory to purify the stem cells within, and then injected into the childs spinal canal. The whole operation took place under general anaesthesia. 10 autistic children aged 4-12 were treated.

I found this pretty shocking. An invasive procedure involving general anaesthesia should only be performed if its medically justified especially in children as young as 4! Bansal et al. provide no scientific explanation for why they thought this treatment was suitable for these patients. They vaguely name immunological and neural dysregulation believed to underlie autism as the target of the cells.

For what its worth, the results showed a slight improvement in autism symptoms after the treatment. However, there was no control group, so placebo effects are likely, and were told that the patients were also given speech therapy, occupational therapy and psychological intervention which might account for the benefits.

So who gave the green light to this project? Well, remarkably, Bansal et al.s paper contains no information about which ethics committee reviewed and approved the study. I dont know about the laws in India, but in the UK or the USA, conducting even the most benign research without the proper ethical approval is serious misconduct. Most journals absolutely wont publish medical research without an ethics statement.

The paper also contains no mention of conflicts of interest another thing that most medical journals require. I believe that financial conflicts of interest are likely to exist in this case because Bansal gives his affiliations as Mother Cell, his own private venture, and RegennMed, who sell various stem cell treatments.

Overall, to say that this paper is ethically questionable is an understatement, and it would have been rejected by any real journal.

This isnt Dr Himanshu Bansals first foray into the amazing world of dodgy stem-cells. He briefly made headlines around the globe last year when he announced his ReAnima project to bring a brain dead woman back to life (with stem cells). Indian authorities eventually blocked his resurrection attempt. Theres some more interesting dirt on Bansal on this forum.

This is also not the worlds first stem cells for autism trial. For example, Duke University launched a $40 million trial in 2014. The treatment in that trial was a blood infusion, so it was pretty non-invasive: no bone marrow, spinal needles, or general anaesthesia. However, critics argue that its pure speculation to think that stem cells would help in autism. Then again, the same could be said about a great many stem cell therapies.

Bansal H, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. (2016). A Short Study Report on Bone Marrow Aspirate Concentrate Cell Therapy in Ten South Asian Indian Patients with Autism Journal of Stem Cells, 11 (1)

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Unethical Stem Cell Therapy for Autism In India? - Discover Magazine (blog)

A non-surgical treatment that uses a patients own bone marrow stem cells to treat chest pain or angina improved both symptoms and the length of time treated patients could be physically active, according to recent research.

Angina is chest pain or discomfort caused when the heart does not get enough oxygen-rich blood due to narrowing or blockages in the arteries leading to the heart.

Most studies that have explored stem-cell therapies for angina required surgery to directly inject stem cells into the heart muscle or the heart blood vessels.

We injected a catalyst molecule that caused bone marrow stem cells to enter the patients blood, then harvested them to re-inject into the patient.

This is not considered a surgical procedure, is easy to implement, and allows for repeated administrations, said Hadyanto Lim, Ph.D., study senior author.

Fifteen patients were first injected with a molecule called granulocyte colony stimulating factor (G-CSF) once a day for four days.

G-CSF stimulates stem cells to migrate into the bloodstream from the bone marrow where they reside. Stem cells have the ability to transform into different types of cells.

On the fourth day, three hours after the last G-CSF injection, blood was drawn and stem cells were separated from the blood.

Stem cells were identified by the presence of a protein called CD34 on the cells surface.

Thirty minutes after the cell separation procedure finished, the collected stem cells were injected back into the patient through an IV.

Four weeks after receiving the treatment, patients experienced significantly fewer angina-related symptoms, and they were able to exercise at a higher intensity and for a longer period of time.

Most patients also reported mild muscle pains in their backs or legs, but the pain could be managed with acetaminophen.

When lifestyle changes and drug therapies do not control chest pains and discomfort, patients are often recommended for surgical procedures.

This includes coronary angioplasty in which a small mesh tube is inserted in the narrow heart artery to open it up and coronary artery bypass grafting in which healthy blood vessels are used to shunt blood around the narrowed heart arteries.

However, 20 percent to 30 percent of patients with severe coronary atherosclerosis are not suitable for these interventions.

The studys limitations are the small number of patients and absence of a control group. Because no control group was used, the placebo effect cannot be ruled out, Lim noted.

Although this treatment is currently used to treat some cancers multiple myeloma and lymphoma it will need more investigation before it can be made available to the general public to treat angina, according to Lim.

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Having chest pain? Your own stem cells may help with the treatment - Knowridge Science Report

Clinical Pain Advisor (registration)

Stem Cell Therapies for Degenerative Disc Disease Clinical Pain Advisor (registration) MSCs derived from bone marrow have been successfully differentiated into cardiopoietic cells and used in treatment of heart failure. Fourth- and fifth-generation techniques use genetically modified MSCs and induced pluripotent stem cells (iPSCs), ...

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Stem Cell Therapies for Degenerative Disc Disease - Clinical Pain Advisor (registration)

Gizmodo

3 Women Blinded After Stem Cell Therapy Newser CORRECTS FROM MD ANDERSON HOSPITAL TO MD ANDERSON CANCER CENTER -Senior Clinical Cell Therapy Specialist Megan Raggio prepares stem cells from bone marrow before they are transplanted into sportscaster... (AP Photo/David J. Phillip). Florida Clinic Blinds Three Patients in Botched 'Clinical Trial'Gizmodo Stem Cell Therapy Market To Grow At A CAGR of 36.52% From 2017 To 2021 : Radiant Insights,IncMedgadget (blog) From Hope To Despair: Three Women Blinded By Unproven Stem Cell Therapy [VIDEO]Counsel & Heal The New England Journal of Medicine -National Eye Institute - NIH -ClinicalTrials.gov all 95 news articles »

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3 Women Blinded After Stem Cell Therapy - Newser

I recently donated peripheral blood stem cells (PBSC) to a middle-aged man with myelodysplastic syndrome. This is similar medically to a bone marrow donation (though less painful) and much more involved than a blood donation (which I have done regularly since I was seventeen). I found the whole process fascinating and a testament to the glory of mans mind and modern civilization.

The patient with myelodysplastic syndrome lives in central Europe. His bodys bone marrow was no longer producing healthy functioning blood cellsthat is, red blood cells, white blood cells, and plateletsa deficiency that could have resulted in his bodys loss of ability to fight infections or control bleeding, and possibly leukemia. The cure for his disease involved destroying his defective natural bone marrow and replacing it with someone elsesmine.

Bone marrow compatibility between donor and recipient is more complicated than blood types. He needed a donor whose human leukocyte antigen (HLA) proteins most closely matched his own in order to minimize the chance of graft-versus-host disease. His doctors found my data in the Be the Match Registry, where Im registered as a potential donor, and they judged my HLA proteins to be his best hope.

Eight weeks before the operation would take place, I was notified by phone about the match and the donation process. I was then asked whether I was willing to donate. I said yes (and was given several opportunities later to change my mind). In the following weeks, I provided two sets of blood samples to verify that I was healthy enough to donate and still a good match. I was flown out to the donation facility in Michigan to be examined physically, preview the process, and speak with the doctors and nurses who would collect the donation. My donor representative called me periodically to keep me informed and to verify my continuing consent. She also made the arrangements for collecting the samples, managed my travels, and ensured that my expenses were covered.

Here I am holdingthe final product just prior to its transportation to the recipientin central Europe.

As the donation date drew closer, I received ten shots of Filgrastim, a drug designed to stimulate additional blood stem cell formation, one shot in each arm for five days. This increased my white blood cell count far above normal and forced extra blood stem cells into my bloodstream, thus enabling the technicians to run my blood through an apheresis machine, which separated the phases of blood by density using centripetal acceleration. On the donation day, I sat in a comfy chair with an IV in each arm for four hours as a machine took blood from one arm, separated out the stem cells, and returned the rest of my blood via my other arm. While the process continued throughout the morning, the nurses took a few notes here and there, and, as my arms couldnt bend, fed me lunch (chicken wings from Jets Pizza). Once the machine had collected enough stem cells for the recipient (Im fifteen pounds heavier than he is, so it was easier on my body than it could have been), the IVs were removed, my blood was tested one final time to make sure I was OK to drive home, and I left.

My blood stem cells were then transported by private courier to the patient in central Europe. In preparation for the donation, his entire immune system and blood-producing machinery (bone marrow) had been destroyed using myeloablative chemotherapy in order to eliminate any remaining diseased cells and to suppress any immune response from his body to my replacement tissue. My blood stem cells were injected into his bloodstream by IV and then migrated to his bones to replace his destroyed bone marrow and eventually start producing new red blood cells, white blood cells, and platelets. Essentially, my blood and my immune system are regrowing in his body. With these, he inherits my allergies and infectious disease history, and, if all goes well, my life force for another few decades.

Although the organization through which I donated does not pay for stem cells (because payment is against international registry standards), I was treated well and fully reimbursed for expenses. They paid for flights, a half dozen meals, a private driver at one point, hundreds of miles of my own driving, and my stays at nice hotels.

It is worth noting that the Institute for Justice (IJ) recently sued the U.S. attorney general to legalize bone marrow and stem cell donor compensation.1 As the IJ reports, the Ninth Circuit ruled in our favor, holding that the National Organ Transplant Acts ban on donor compensation does not apply to the most common method for donating marrow. This victory is especially helpful for certain minorities and people with multiracial ancestries who face significantly reduced odds of finding unrelated marrow donors. But direct compensation has been met with strong resistance by the major national and international marrow registry organizations, which also lobbied against IJs efforts in court.2 Currently, compensation for donations is being offered only by smaller organizations.

My motivation for donating cannot be reduced to just one reason, but it certainly was not a sacrifice. My reasons varied in depth and weight, but all were self-interested. I thought the process itself was fascinating. I was able to ask the doctors and nurses unlimited questions and to experience firsthand a medical procedure about which I had no previous knowledge. I enjoyed business-class travel, which, as a college student was a significant treat. Most broadly, I participated in an important aspect of the kind of civil society in which I want to live. I want someone to be willing to donate lifesaving tissue to me or my loved ones, should we need it in the future, and I was happy to donate first. The costs were trivialabout twenty-five hours of volunteered time and some minor discomfort. Overall, the experience was positive and spiritually rewarding.

The option to make a donation of this kind did not even exist a few decades ago. It is a function of many interrelated parts of todays modern, relatively free-market, science-oriented cultures. The establishment and maintenance of an international donor registry requires stable, relatively rights-protecting legal systems that enable long-range and large-scale planning among cooperative strangers. To find matches in a timely manner requires the speed and integrating capacities of computers and the Internet. The medical procedure itself requires the kinds of scientific knowledge and expensive technologies made possible by todays relatively free markets. The ability to pay for such a procedure requires substantial personal wealth, which more people have today than ever before. I am exceedingly grateful to live in our rich, science-oriented, relatively capitalist civilization at the time that I do. And I hope the recipient of my donation is able to enjoy many years more of living and loving life as I do.

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Endnotes

1. Bone MarrowNOTA Challenge, Institute for Justice, http://ij.org/case/bonemarrow/.

2. Coalition Says PBSC Donor Compensation Poses Health Risks to Patients and Donors, Be the Match, February 2, 2012, https://bethematch.org/news/news-releases/coalition-says-pbsc-donor-compensation-poses-health-risks-to-patients-and-donors/.

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My Non-Sacrificial Donation of Stem Cells to Save a Life - The Objective Standard

A retina with macular degeneration. (Image: University of Iowa)

An unproven stem cell therapy conducted by a Florida clinic has blinded three patients in an apparent clinical trial gone horribly wrong. The incident showcases the extent to which unscrupulous clinics will take advantage of desperate patientsand how the lack of government oversight contributes to the problem.

As reported in the New England Journal of Medicine, the clinical trialif it can be called thatinvolved three women between the ages of 72 and 88 who were suffering from macular degeneration, a common progressive disease of the retina that leads to loss of vision. The women, all of whom were experiencing various degrees of vision loss, sought the help of a Florida clinic, which claimed to be testing a stem cell procedure designed to treat macular degeneration. Sometime in 2015, a week after stem cells were injected into their eyes, the women became blind. Two years later, doctors say theres virtually no chance the womens vision will be restored.

The authors of the new report, ophthalmologists Jeffrey Goldberg from Stanford University School of Medicine and Thomas Albini from the University of Miami, said the unfortunate incident serves as a call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research.

Stem cells are undifferentiated cells that havent quite decided what they want to be when they grow up. Under the right conditions, these immature cells can be transformed into virtually any kind of cell found in the body, which is why theyve proven useful in regenerative medicine.

Eventually, scientists hope to be able to use stem cells to regenerate damaged tissue and organsand possibly even repair the effects of macular degenerationbut were not there yet. The only truly effective clinical application of stem cells to date has been in bone marrow transplants, in which stem cells extracted from a donors bone marrow are used to produce a fresh blood system for patients suffering from blood disorders such as leukemia. A recent study showed that there are nearly 600 clinics peddling unproven stem-cell procedures in the United States for a wide range of conditions, including arthritis, autism, cerebral palsy, stroke, muscular dystrophy, and cancer.

As noted in the NEJM report, two of the three patients learned about the stem cell trial for macular degeneration on ClinicalTrials.gov, a registry run by the US National Library of Medicine. The listings on this site arent fully scrutinized for scientific efficacy. The patients were reportedly under the assumption that they were participating in a bonafide clinical trial, but the consent form and other materials made no mention of a trial. Tellingly, each patient had to pay $5,000 for the procedure. This is highly unorthodox for a clinical trial, and it should have been cause for alarm. Im not aware of any legitimate research, at least in ophthalmology, that is patient-funded, Albini said in a statement.

The NEJM study didnt identify the Florida clinic responsible, but (conveniently) the authors provided the name of the trial: Study to assess the safety and effects of cells injected intravitreal in dry macular. A quick Google search calls the trial up, along with the name of the company responsible: Bioheart Inc., otherwise known as US Stem Cell. As the ClinicalTrials.gov page indicates, the study has been withdrawn prior to enrollment. According to Goldberg and Albini, the company is no longer performing the procedure, but it is still seeing patients.

The trial itself was a joke, lacking in all the components of a properly designed test. It wasnt based on prior laboratory experiments, no control group was assigned, no data was collected, and no plans were made for follow-ups.

During the procedure, the patients had some of their fat cells (i.e. adipose tissue) removed, along with a standard blood withdrawal. The fat tissues were then processed with an enzyme to draw out stem cells. Once plasma was isolated from the blood and added to the stem cells, the mixture was injected into both eyes of each patientyes, both eyes. Again, another serious clinical no-no; normally, only one eye would be injected for an experimental procedure like this in the event that something should go wrong. The entire procedure lasted less than an hour.

A week later, all three women were blind. As noted in the NEJM report, the blindness was accompanied by detached retinas and hemorrhaging.

The patients severe visual loss after the injection was associated with ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined traction and rhegmatogenous retinal detachment, and lens dislocation. After one year, the patients visual acuity ranged from 20/200 to no light perception.

Goldberg and Albini say the preparation of the stem cells was likely shoddy, and the injections may have been contaminated. Once in the eye, the stem cells could have changed into myofibroblasts, a type of cell associated with scarring.

The Florida clinic, it would appear, was appealing to the desperation of their patients, while taking advantage of a regulatory loophole. As the authors write in their report:

Adipose tissuederived stem cells have been increasingly used by stem-cell clinics because of the relative ease of obtaining and preparing these cells. Many of the clinics that provide these stem-cell therapies have done so under the auspices of patient-funded, institutional review boardapproved research, and the research is listed on ClinicalTrials.gov without an investigational new drug filing with the FDA.

At the time, the procedure was not subject to FDA approval because the cells werent transferred between patients, and because the cells were considered minimally processed. The FDA has since revised its requirements, and it now needs approval for these types of procedures. In addition to updating its regulations, the FDA is also clamping down on stem cell clinics.

Thats obviously a good thing, but its a little too late for the women involved. This incident shows what happens when regulations and oversight are weak, and how shady companies will take risks with their patients health. Certainly food for thought as Trump and his cronies start to recreate the FDA in their own image.

Update: We reached out to US Stem Cell Clinic for comment and they responded with this statement:

Founded in 1999, U.S Stem Cell, Inc. has been committed to the research and development of effective cell technologies to treat patients with a variety of diseases and injuries. Since 2001, our clinics have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations. Neither US Stem Cell nor US Stem Cell Clinic currently treats eye patients.

[New England Journal of Medicine]

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Florida Clinic Blinds Three Patients in Botched 'Clinical Trial' - Gizmodo

There is a fine line between falling for the delusion of the next magic pill and getting excited about the promise of the newest medical technologies. There is a risk in thinking too optimistically about the idea that whatever is wrong now, will be fixed later by technology or medical advancement. Taken to its logical conclusion, this way of thinking can lead to shirking responsibility in the present and even sacrificing quality of life in the here and now for the, sometimes false, promises of there being better things to come.

Yet, at the same time, without the hope or aspirations that come with the promise of medical advancement and that future therapies may be more effective than what our current technologies allow, progress may never be realized. So, it is with this word of caution in mind, that we will be reviewing some of the newest and most exciting medical technologies that are headed our way. The following three developments are well researched and have the potential to make huge improvements in many of our lives.

Nasal cartilage used to repair the knee: A type of stem cell therapy in which nasal chondrocytes are harvested, replicated, then grafted onto damaged joint surfaces is showing tremendous potential to restore the health and integrity of joints. Joint degeneration of knees, hips or even facet joints of the spine which can cause debilitating joint and/or back pain may all be treated by this new technology that would allow doctors to re-surface worn out joints. This approach is being tested in Sweden and in admittedly small sample sizes, is showing incredible results. If this technology continues to prove its reliability and value, it may be the end of joint replacement surgeries around the world.

Bone marrow stem cells to repair meniscal tears: If conditions involving the degeneration of joint surfaces are some of the most common orthopedic issues we collectively experience as we age, damage to soft tissue structures, like the meniscus in the knee or the labrum in the shoulder, are runners up. Another stem cell technology this time using stem cells harvested from ones own bone marrow is showing the potential to non-surgically repair these soft tissues. Researchers in Great Britain have demonstrated the potential of stem cells to be turned into a cell bandage that was able to heal meniscal tears that would otherwise require surgical intervention to simply remove or repair in order to treat.

CRISPR: Clustered regularly interspaced short palindromic repeats, otherwise known as CRISPR, is the common name for a gene editing technology based on a loophole found in our DNA which allows scientists to very precisely and very specifically cut and edit gene sequences. This technology literally allows us to re-write our genetic codes in a safe, relatively cheap, and extremely effective way. The promise of this technology is difficult not to overstate, but it has already demonstrated the potential to cure otherwise incurable genetic diseases like muscular dystrophy and sickle cell anemia. Other potential applications are basically unlimited as are the ethical implications of having this much power.

Regardless of what new technology is being developed in the wings, it is critical to remember that whether you are currently experiencing pain from arthritic knees or suffering from an autoimmune disease, there are libraries of research to support the benefits of currently available therapies. Physical therapy, specifically, has something to offer anyone looking to move or feel better - and is available right now!

If you have any questions about this article, or want to find out more about scheduling a nutritional consultation, contact Dr. Chris Telesmanic, PT, DPT, OCS at chris@alliancehealthfresno.com. Learn more about movement, fitness and health in this space each week or by visitingwww.alliancehealthfresno.com, or calling 478-5833.

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New medical technologies verses the 'magic pill' - Hanford Sentinel

"The impact of Alzheimer's disease is vast, far exceeding the medical community's current ability to treat it," said Joshua M. Hare, M.D., Longeveron's Co-Founder and Chief Science Officer. "Regenerative medicine and cell-based therapies offer a promising new approach to close this gap and address the urgent need for effective therapies to combat the condition."

An important component in the progression of Alzheimer's disease is neuroinflammation. Longeveron was recently awarded a $1 million Part the Cloud Challenge on Neuroinflammation grant from the Alzheimer's Association to help support this research.

"Adult stem cells are very potent anti-inflammatories. The characteristic amyloid plaques found in the brains of Alzheimer's disease patients produce inflammation, and stem cells can reduce inflammation," explained Bernard S. Baumel, M.D., Principal Investigator for the trial. "Alzheimer's also impairs the brain's ability to adequately produce new brain cells in the memory area known as the hippocampus. Stem cells can stimulate the brain to produce these new cells needed to form memory. We believe that an infusion of LMSCs may improve the condition or at least halt the progression of the disease."

Prior research shows that adult MSCs target and reduce inflammation, promote tissue repair and improve brain function in mouse models of Alzheimer's disease. Longeveron's trial is the first U.S. clinical study of exogenously administered mesenchymal stem cells derived from the bone marrow of healthy adult donors for treating Alzheimer's disease.

To learn about participating in the clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT02600130

About Longeveron

Longeveron is a regenerative medicine therapy company founded in 2014. Longeveron's goal is to provide the first of its kind biological solution for aging-related diseases, and is dedicated to developing safe cell-based therapeutics to revolutionize the aging process and improve quality of life. The company's research focus areas include Alzheimer's disease, Aging Frailty and the Metabolic Syndrome. Longeveron produces LMSCs in its own state-of-the-art cGMP cell processing facility. http://www.longeveron.com

Contact: Suzanne Liv Page spage@longeveron.com 305.342.9590

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/longeveron-achieves-milestone-in-groundbreaking-stem-cell-trial-for-alzheimers-disease-300424206.html

SOURCE Longeveron

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Longeveron Achieves Milestone in Groundbreaking Stem Cell Trial for Alzheimer's Disease - PR Newswire (press release)

A longtime product developer is bringing a peptide ingredient to the US market that has been researched for a unique property promoting the growth of bone marrow stem cells.

Called DH Stemogen, the product is the brainchild of Dr Marvin Heuer MD who has a history of product development with sports nutrition company MuscleTech. Dr. Heuer has a background in clinical research, having spent many years in drug development at Glaxo Smith Kline. He also runs a contract research firm, Heuer M.D. Research Inc. and is the CEO of omega-3 supplement manufacturer Blue Ocean Nutrascience.

The new product, called DH Stemogen is based on a Cyclo-{L-ALA-L-GLU(TRP-OH) peptide that was developed by a Russian biochemist.

Its a peptide that is a mimic of a naturally occurring thymic peptide,Dr. Heuer told NutraIngredients-USA. Heuer was promoting the launch of the product at the recent Expo West trade show in Anaheim, CA. At Heuer M.D. Research, as a company we are out looking for novel ingredientsto bring out, hopefully in the nutraceutical area.

We got interested in Prof. Vlad Deigins peptide research, Dr. Heuer said (Deigin is associated with the Institute of Bioorganic Chemistry at the Russian Academy of Sciences in Moscow.)We looked at this particular compound that he was launching as an ingredient in Russia about a year ago.

The peptide in DH Stemogen targets a particular type of stem cell hematopoietic cells (HSC). Stem cells in general are the building blocks of our bodies. These cells are able to transform themselves into almost any type of cell. There are various sources of stem cells in an adult body. One of the most important of them comprises the bone marrow, where the HSCs are produced. HSCs transform into all the main cell types in our blood, including red blood cells and white blood cells. Dr. Heuer said there is some evidence that those cells are able to reconstruct other body tissues by transforming into the specific tissue type cell such as liver, nervous tissue, kidney and skin.

These properties would seem to make Stemogen a natural for a healthy aging product positioning, Dr. Heuer said. But Deigins research, trending as it does over into disease endpoints, is a little problematical when it comes to supporting US-style structure function claims, he admitted. Other countries dont make the same hard and fast distinctions between dietary ingredients meant for supplement applications and active pharmaceutical agents meant for drugs, he said.

We are going to be very cautious about making structure/function claims,Dr. Heuer said. The product at the moment saysSupport your immune system and Support healthy levels of stem cells in your blood.

We are about to begin a whole profile of research in the U.S. and Canada, he added.

Dr. Heuer said one thing thats unique about the ingredient (and something that he says Deigin has patented) is a structural twist that improves the peptides stability. The criticism of some other novel peptides has been that interesting as their properties might be, once they hit the stomachs gastric fluid they blow apart into their constituent amino groups and all those novel properties are lost.

He has a patent on the way he makes this with a hex ring on the end that protects it in the GI tract and allows it to be absorbed,he said.

Bringing a synthetic analogue of a naturally occurring peptide to market as a dietary ingredient would seem to pose significant regulatory challenges. Dr. Heuer said hes confident there is a way through that thicket. The plan is to start first with a GRAS filing, and Dr. Heuer said he believes that the peptide would fall under the amino acid category in the DHSEA definitions of what constitutes a dietary ingredient.

Certainly there is a precedent of complex peptides being sold on the market, he said.

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Peptide aimed at stem cell genesis debuts on supplement market - NutraIngredients-usa.com

Adam Krief, with his wife, Lia, had a rare form of blood cancer that proved to be fatal. (Facebook)

(JTA) Adam Krief, a Jewish cancer patient whose search for a bone marrow donor captured the attention of social media and celebrities including Kim Kardashian, Mayim Bialik and Jason Biggs, has died.

Krief, a father of three from Los Angeles, died Tuesday, a family friend confirmed to JTA. He was 31.

Krief was diagnosed with primary myelofibrosis, a rare form of blood cancer that is likely fatal if a stem celltransplant matchis notfound.To find anHLA, or gene complex matchfor Krief something more difficultto track downthan a blood type match drives were held around the world, including in North America,Israel, France and Mexico.

Kardashian posted about Krief on Facebook in September, saying he was a friend of a friend.

A bone-marrow donor was found last December seven matches were found, in fact, through the donor drives organized for him.

This is what cloud 9 looks like Im so grateful to let you all know that a donorhas been found, Krief wrote at the time, sharing a video with two of his children.

The Hope 4 Adam Facebook page on March 8 called for a Worldwide Unity Shabbat for March 11 and March 18 for the recovery of Krief, asking followers to Help us bring about a miracle.

On Monday, the Eretz Kabbalah Facebook page of the Los Angeles-based Eretz Cultural Center posted a call for followers to recite Tehillim, or psalms, on behalf of Krief.

After a long search for a bone-marrow match to save his life, he finally received one. However, after some complications, he is said to only have a few hours to live, the post said.

Krief is survived by his wife, Lia, and his young children.

RELATED:

Jewish cancer patient finds bone marrow transplant following worldwide search, Kim Kardashians pitch

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Adam Krief, Jewish father of 3 whose bone marrow search inspired ... - Jewish Telegraphic Agency

March of the Men is a month-long campaign run by Anthony Nolan, the blood cancer charity, which seeks to recruit as many young men aged 16-30 to the register as possible.

AnthonyNolans aim to find a match for every person in need of a stem cell or bone marrow transplant. Young men aged 16-30 currently account for just 16% of the register, but provide over 50% of all potentially lifesaving transplants. This is why theMarch of the Men campaign is so important.

On average, people on the register have a 1 in 790 chance of being asked to donate stem cells or bone marrow in the next five years, whereas a man aged 16-30 has a 1 in 170 chance. As our research indicates that young men provide better outcomes for patients, its of vital importance that we encourage more of them to sign up as potential stem cell donors.

Marrow is the collective name given to AnthonyNolans student volunteer network. Operating in over 50 universities across the UK, Marrow groups campaign, fundraise and crucially recruit young students to join the stem cell register on our behalf. Incredibly, donors recruited at university by Marrow groups account for more than a quarter of all potentially lifesaving transplants that take place in the UK each year.

As the Marrow Volunteer Engagement Coordinator at AnthonyNolan, my job is to develop and deliver training workshops and presentations for our student volunteers. I also help to oversee the quality of our university recruitment events to make sure that procedures are being followed properly, and that were recruiting potential stem cell donors in the best possible way.

Recently, the AnthonyNolanResearch Institute (ANRI) carried out the largest-ever UK study into the factors that can make a stem cell transplant more successful. Early indications show the age of the donor can affect patient outcomes, with younger donors leading to better survival rates.

Marrow groups at universities have access not only to young people, but young people from a vast range of ethnic backgrounds, meaning they are of fundamental importance.

I recently had the pleasure of meeting a young man called Chris Lane at The London Clinic while he was donating his stem cells. Coincidentally, it turned out that it was me who had signed him up to the AnthonyNolanregister when I was a Marrow volunteer two years ago. He said: I had only briefly heard of AnthonyNolanbefore signing up. It wasnt until I saw a stand at university that my curiosity to find out more led me to want to be included on the register.

I had never thought about how I would feel or react to being told that I was required to donate but when it happened, I felt a sense of pride and required no second thought to follow through with whatever was required.

I think about the person who received my cells every day. Life is the best gift you could ever give someone so my fingers are always crossed for them.

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March of the Men - The Hippocratic Post (blog)

March 13, 2017 6:01 PM By Stephanie Stahl

PHILADELPHIA (CBS) Doctors at the University of Pennsylvania School of Veterinary Medicine are conducting a study to see if stem cell therapy will ease the pain of arthritis and the results of their research could benefit human patients as well.

Its Zoeys last check up,walking on a special mat called a forceplate to measure how much weight she puts on each leg.

It was just a year ago that putting weight on her front legs was painful.The 2-year-old Golden Retriever was diagnosed with elbow dysplasia, a condition that created arthritis in both elbows.

It is the most common cause of chronic pain in dogs, saidDr. Kimberly Agnello at Penn Vet.

Zoeys owner, Christine Brown, says she was a bundle of energy when she first got Zoey.

She was so sweet, said Brown. She was your typical energetic puppy.

But soon Brown knew her dog was hurting.

After coming back from a walk and taking a nap, she would get up and limp, said Brown. With her being a puppy it was devastating.

Zoey was enrolled in aPenn Vet trial to determine the benefits of stem cell therapy as a treatment to ease arthritic pain.

They are randomized into three groups, whether they receive an interarticular joint injection of hyaluronic acid or they geteither stem cells derived from their bone marrow or stem cells derived from fat, saidAgnello.

The stems cells from the dogs bone marrow are injected back into the elbow joint. Doctors hope it will relieve the arthritic pain.

We also remove a little fragment of bone that can be causing some more pain, saidAgnello.

The research isnt just about arthritis in dogs but humans as well.

The goals of this study are to look for different treatments to not only help our canine patientsbut also to help human patients with arthritis, saidAgnello.

For now results are promising.

Oh my gosh, she is not limping, she runs and jumps, and has a great time, said Brown.

The trial is ongoing so there is no hard data yet to show final results if stem cells are effective for treating arthritis, but Dr.Agnello says there are many dogs in the study and almost all of them have improved during the year-long research.

Stephanie Stahl, CBS 3 and The CW Philly 57s Emmy Award-winning health reporter, is featured daily on Eyewitness News. As one of the television industrys most respected medical reporters, Stephanie has been recognized by community and he...

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Veterinary Doctors Conduct Study Looking To Ease Arthritis Pain - CBS Philly

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Stem Cell Therapy Runner's World This is why researchers and physicians think this therapy may help joint injuries caused by worn-out cartilage; in cell cultures, stem cells can grow new cartilage, and if this can happen in a joint, it may prevent the need for a joint replacement ... Nutrients Boost Stem Cell FunctionProHealth At 6th Annual Clinical Trial Supply New England 2017 Conference in Boston Asymmetrex Introduces A First Specific ...Benzinga Research report explores the stem cell therapy market worth 145.8 million USD by 2021WhaTech all 14 news articles »

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Slide: 1 / of 1. Caption: Getty Images

Last week, as tens of thousands of US and South Korean soldiers gathered at a base in Iwakuni, Japan for an annual joint military exercise, North Korea fired four ballistic missiles from Pyongyang into the sea off Japans northwest coast. In a world where the US is headed by a Twigger-happy political neophyte and the risk of a Cold War reboot looms larger with each Wikileaks disclosure, this demonstration wasnt just an empty display of dictatorial propaganda. It was a reminder that the nuclear threat is still alive and well.

But even if youve taken a decades-long break from stocking your fallout shelter, the federal government hasnt. Over the last ten years the US has poured millions of dollars into technologies and treatments it hopes to never have to use, but could, in the event of a nuclear catastrophe. From assays that measure radiation exposure to cell therapies that restore dwindling blood cells to liquid spray skin grafts, government officials are now far better equipped to deal with diagnosing and treating people if the unthinkable were to happen. And the next generation of treatments are being funded right now.

In 2006, the Department of Health and Human Services established the Public Health Emergency Medical Countermeasures Enterprise to coordinate federal solutions to large-scale public health threats, including the nuclear one. Pretty much every agency you can think of is involvedCDC, NIH, FDA, DoD, DHS, USDA, VA, and OEM, among others. But in terms of nuclear countermeasures, three programs nested within HHS do the bulk of the heavy lifting.

The NIHs National Institute of Allergy and Infectious Disease is the first stop; it runs clinical and preclinical trials for promising technologies. Then theres the Biomedical Advanced Research and Development AuthorityBardawhich is basically a taxpayer-backed investment firm that develops these potential drugs, vaccines, treatments, and supplies and ushers them through FDA approval. Finally theres Project BioShield, which contracts with companies when their products are almost ready, ensuring a national market. To date, the project has acquired 12 products related to a nuclear blast or reactor meltdown, some FDA-approved, some still in late stage development, but all destined for the Strategic National Stockpile, the CDC-managed backup supply of drugs and medical supplies for use in a public health emergency. And each class of products addresses a different part of the threat.

The first is diagnosis. When a person is exposed to high levels of radiation, unpaired electrons careen around their cellular machinery, breaking DNA and causing damage to every organ, including the bone marrow. This means you cant generate new red blood cells, white blood cells, and platelets, so you cant fight off infections or coagulate your blood. People usually dont start feeling the effects of acute radiation syndrome for 24 to 48 hours, but damage to their cells DNA starts almost immediately. Which is why you need a reliable diagnostic device; following a nuclear event, people who feel well might actually be in danger, and people who werent exposed will want treatment just to be safe.

So Project BioShield acquired two diagnostic devices, known as biodosimeters, to tell the difference. One works by measuring gene expression, the other by visually analyzing cell nuclei. In the event of a nuclear event, the countermeasures weve procured will be precious resources, says Joe Larsen, acting director of Bardas division of chemical, biological, radiological, and nuclear medical countermeasures. Were going to end up with a lot of worried well demanding treatment, and we can only afford to treat people that need it.

That treatment, at least right now, consists of injections of immune-boosting cytokines, developed for cancer patients to restore depleted white blood cells lost during radiation treatments or chemotherapy. Project BioShield has acquired three such cytokine treatmentsbut, Larsen notes, they wont work for about 20 percent of people. For them, the only option will be bone marrow or cord blood transplants, which come with the extra obstacle of having to be matched with a donor. So Barda and Project BioShield are now looking for cellular therapies that dont require any donor matching to their portfolioa universal treatment. That could shore up gaps in our initial capability to treat radiation. And theyve got at a few promising options coming down the pipeline.

Barda recently signed a $188 million contract to developa stem cell therapy produced by California-based Cellerant Therapeutics, which restores white blood cells in leukemia patients whove had theirs taken outby chemotherapy. The cells are cryopreserved and shelf-stable, important features for a stockpile item. But the treatment is focused on white blood cells, and radiation exposure doesnt limit itself to the immune systems front-line fighters.

To that end, NIAID is funding clinical trials for a placenta-derived stem cell treatment developed by an Israeli company, Pluristem, that has shown the ability to restore all three blood cell linesred and white blood cells, as well as plateletsin animal models. Like Cellerants, the treatment comes cryogenically frozen along with a thawing device to deploy it easily in the field. The cells stay viable on liquid nitrogen inside their canisters, so you dont have to worry about losing them if the power goes out. From their injection site, the placental stem cells sense stress signals in bone marrow tissues, and send more than 20 signaling molecules to repair and restore their functions. The company isnt testing efficacy in humans, for obvious reasons. But Pluristem says their animal studies showed close to 100 percent survival rates with the treatment, compared to 30 percent without.

Arik Eisenkraft, who began working on an ARS application for Pluristems technology following the Fukushima disaster, isnt surprised that a potential solution to nuclear radiation would come out of a place like Israel. We live in a world of imminent threats, not theoretical ones, he said. Even though we dont have the same budgets and the same scope of institutes, what we do have is a real sense of urgency.

Neither Barda nor Pluristem could confirm whether or not a contract is somewhere in their future. But the agency did say it was looking at all the options. And with Bardas budget cut by $160 million last year and an uncertain future for disaster preparedness funds in a Trump administration, theres no time like the present for some urgency of their own.

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The Feds Are Spending Millions to Help You Survive Nuclear War - WIRED

TiGenix announces positiveone-year results forits phase I/II trial of donor-derived cardiac stem cell therapy in acute myocardial infarction (AMI).

The Belgian biotech TiGenixis developing allogeneic stem cell therapies. Now the companyhasannouncedthat its cardiac stem cell therapyAlloCSC-01 reached its primary endpoints in aphase I/IItrial.

In 2015, the companyacquired Coretherapixin a292M deal for its allogeneic cardiac stem cell pipeline, which is being developed for the treatment of AMI.The first-in-human trial was designed to test the safety and feasibility of an intracoronary infusion of donor-derivedexpanded cardiac stem cells (AlloCSCs)in patients with AMI and left ventricular dysfunction.

AlloCSC-01consists of adult allogeneic cardiac stem cells isolated from the heartof donors and expanded in vitro. In vivo studies suggest that these cellshave cardio-reparative potential by activating regenerative pathways and promoting the formation of new hearttissue.

Thecurrent phase II study demonstrated thesafety of these allogeneic stem cells. Initial results also revealed a larger reduction of infarct size in a subgroup of patients.

Myocardial infarction caused by blockade of coronary arteries

TiGenix is well known forChondroCellect, which was the first cell therapyto reach the European market for the repair of knee cartilage.After the companyrecently withdrew its market authorization for this product, due to a lack of reimbursement, the biotech is focusing on another stem cell therapy, Cx601, in addition to AlloCSC-01. Under development for Crohns disease, Cx601 is currently awaitingEMA approval and is in phase III trials in the US.

For a late-stage clinical company, TiGenix has a low market cap of191M. Even so, the company seems to be doing well these days with the progress of Cx601 and AlloCSC-01.

If AlloCSC-01 obtains market approval, it could treat the more than 1.9 millionpeople affected by AMI, a major cause of heart failure. So far, most treatments are palliative or restore myocardial function by angioplasty and insertion of a stent to support the vascular lumen.

Stem cell therapy of the heart is definitely not a new topic, but many trials have been conducted using the patients own stem cells derived from the bone marrow. A recent meta-analysisof such trials has suggested that these therapies are safe, but do not enhance cardiac function. TiGenixs approach using allogeneic heart-derived stem cells may offer a new and promisingopportunity in thefield.

Images via shutterstock.com / Liya Graphics andVeronika Zakharova

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New Cardiac Stem Cell Therapy passes Phase I/II Trials - Labiotech.eu (blog)

SPOKANE, Wash. - A simple cheek swab and a few minutes of your time could save the life of someone in need of a bone marrow transplant.

In 2015, 34-year-old Danielle Vaughan had a stem cell transplant to save her life. For nearly a decade she suffered from mysterious symptoms and illnesses.

"So I had these spin and brain lesions that were very scary," said Danielle Vaughan of Spokane. "I had seizures. I was seeing doctors at Stanford, University of Washington and in Spokane, trying to figure out what was going on."

Eventually, doctors diagnosed Vaughan with Common Variable Immune Deficiency. Her sister, Dina Medin, also had the disorder and underwent a bone marrow transplant a few years ago. The sisters are two of six people in the world with CVID who have had transplants.

"All other treatment options had failed. There was nothing else, that was the only option," said Vaughan.

In September of 2015, Vaughan traveled to Seattle to prepare for the transplant. Vaughan's medical team turned to Be The Match, a national bone marrow donor registry to find her a match. Vaughan said 44 people came back as a perfect match. Her donor was a 27 year old man from the United States. She'd love to meet him one day.

"I would like to say thank you for really giving me a second chance at life. But mostly giving me the opportunity to watch my kids grow," said Vaughan.

Vaughan is now encouraging others to join Be The Match.

"You don't know who you could be helping and you are going to save that person's life," said Vaughan.

The Dairy Queen in Post Falls at 3560 E Seltice Way is hosting a Be The Match donor sign up on Thursday, March 16th from 1:45 p.m.- 4:00 p.m. To register all you need to do is fill out paperwork and swab the inside of your cheek with a special Q-tip.

Link:
Bone marrow recipient encouraging others to "Be the Match" - KXLY Spokane

A Thursday evening stem cell swab event aimed at finding a match for an eight-year-old Edmonton boy with leukemia was so successful, it ran out of kits.

Brady Mishio has acute myeloid leukemia, a cancer of the blood, and has undergone three rounds of chemotherapy since being diagnosed in November 2016. Doctors say he needs a bone marrow transplant in order to live.

Brady and his dad Terry Mishio.

The transplant needs to come from someone who is a match to Bradys stem cells. What Canadian Blood Services tells, and told me from the beginning, is that the odds are about 50/50 that Brady will find a match, said his father, Terry Mishio.

Matches are made via the Canadian Blood Services (CBS)OneMatch stem cell and marrow network. Its a database that pairs volunteer donors to patients who require stem cell transplants.

According to CBS, donors and patients are matched according to the compatibility of inherited genetic markers called human leukocyte antigens. A perfect stem cell match can be difficult to find, which is why the push is on to get more people registered.

The more people that are in this bank and they check it every 24 hours the more chances that he or some other Edmontonian kids are going to find that match, Mishio said.

READ MORE:Could you save his life? Edmonton boy needs to find stem cell match

Joining the bank is quick, simple and non-invasive: the potential donor just fills out some paperwork and swabs the inside of their mouth with a buccal swab (similar to a Q-Tip.)

A massive swabbing event to potential stem cell donors took place Thursday evening at the Holy Cross Ukrainian Catholic Parish in north Edmonton. Mishio is on leave from his job as a recruiter with the Edmonton Police Service, and several of his policing coworkers were expected to come out in support.

Organizers expected a big turnout, but the response was even greater than they hoped for.

A big crowd of potential stem cell donors getting swabbed at Holy Cross Ukrainian Catholic Parish in north Edmonton. March 9, 2017.

The event was scheduled from 4 p.m. to 8 p.m., but 100 people showed up before the doors were set to open. Mishios co-worker Trishia Comeau said by 7 p.m., 1,100 people had been swabbed and Canadian Blood Services had used up all of the swabbing kits in Edmonton.

Thanks people of Edmonton for helping, we are going to keep this momentum going, Comeau said early Friday morning.

WATCH ABOVE:Terry Mishio talks to Gord Steinke on Global News at 5 from Thursday evenings swabbing event.

If you couldnt make Thursdays event, visit Canadian Blood Servicesfor more information or to set up an appointment. You need to be between 17 and 35 to register.

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A blood and marrow transplant replaces abnormal blood-forming stem cells with healthy cells. These are commonly used to treat blood cancers or other kinds of blood diseases that decrease the number of healthy blood cells in the body.

Dr. Stephanie Williams, specialist in blood and marrow transplant and Lindsay Syswerda, event coordinator talk about blood and marrow transplants, and some upcoming events around the topic.

People who receive a blood and marrow transplants are patients with life-threatening blood cancers, diseases that cause bone marrow failure, and other immune system or genetic diseases

However in order for transplants to take place, cells need to be donated from someone else. Transplants can be donated by either an adult donor, a cord blood unit, or a patient can use their own blood-forming cells.

Spectrum Health works closely with a registry for blood and bone marrow donors called Be The Match, which connects patients searching for a cure and life-saving bone marrow donors. As the largest and most diverse marrow registry, it helps patients get the transplant they need.

Anyone between the ages of 18 and 44 can join the registry, but there are guidelines that are in place to protect potential donors. When there's a possible match for a patient, Be The Match discusses the donor's health history and arranges a thorough physical exam.

If potential donors don't meet the medical requirements to join, there are other ways to help contribute to a cure.

One of the ways people can help with the cause is to join Spectrum Health and the Grand Rapids Griffins in their "Road to Recovery," which celebrates patients, families, and their healthcare team's journey at the Griffin's next home game. On March 31, at the Griffin's next home game, they'll be raising awareness for blood cancers and hope to educate others of the importance to join the Be The Match registry.

To learn more about Be The Match, visit BetheMatch.org and use the codeSHGRG.

If you have been diagnosed with cancer and would like a second opinion or consultation, call 1.855.SHCANCER (855.742.2623).

Read more from the original source:
Be The Match registry seeking blood and bone marrow donors - Fox17

PUBLISHED: 12:56 10 March 2017 | UPDATED: 13:06 10 March 2017

Sophie Morton

Tommy Simpson, five, was diagnosed with leukaemia last year

Nigel Simpson and Maxine Francis

The family of a five-year-old boy battling leukaemia have thanked prospective donors for coming forward after a stem cell match was found.

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Little Tommy Simpson was diagnosed with acute myeloid leukaemia in January 2016, with his parents launching an appeal to find a lifesaving stem cell donor.

His mixed race heritage - his Stratford-based firefighter dad Nigel Simpson is white British and his events manager mum Maxine Francis is black Carribean meant that the odds of finding a compatible donor were stacked against him.

The couple teamed up with the African Caribbean Leukaemia Trust (ACLT), who launched the #Match4Tommy campaign - and a year on, it has proved successful.

Maxine said: It means many things to Tommys dad and me, to know our son has a matched stem cell donor.

It means in the event of Tommy ever requiring a stem cell transplant; there would be no long agonising wait to find a match for our beautiful son.

It means we can move forward, knowing, we have done everything to make sure that whatever happens in the future, our son has all systems in place.

It means peace of mind.

Throughout the search, Tommy has been receiving treatment, to which he is responding well.

But should he relapse, having a stem cell donor already found would mean that he could be treated quickly, offering him a much better chance of survival.

Thousands of people signed up to the stem cell register during the course of the campaign, including at a donor drive held at Nigels workplace, Stratford fire station, which also raised 700 for ACLT.

Maxine, who lives in Barkingside, will be aiming to raise even more money for the charity when she takes on the London Marathon next month.

She said: ACLT supported my family and me throughout Tommys illness, and I want to raise as much funds as possible for them, to enable them to assist much more families in need with their lifesaving work.

Thank you to everyone who helped make this a reality for our small family. We couldnt have got this far without your help.

To sponsor her, visit uk.virginmoneygiving.com/MaxineFrancis. For details on how to join the register, visit aclt.org

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Success for Match4Tommy as bone marrow match found for ... - Newham Recorder