Archive for the ‘Bone Marrow Stem Cells’ Category

Mar. 27 /CSRwire/ - As an international non-profit organization, every day DKMS provides 20 lifesaving blood stem cell transplants for blood cancer and blood disorder patients all around the world. Even in the current situation that we are facing with COVID-19, these patients still urgently need our help. It is for this reason that we keep fighting and continue to work together and collaborate with the international blood stem cell community to be able to overcome all barriers, to give as many patients as possible, who are in urgent need of a life-saving blood stem cell transplant, with a second chance at life.

IMPORTANCE OF REGISTRATION

Due to the advice and directions from the health authorities regarding the COVID-19 virus and to play our part to flatten the curve, we have postponed all of our planned donor drives/registration events in all of our six countries. We want to make sure that we look after and protect all of our donors and volunteers. For the thousands of patients around the world who are not able to find a perfect match, we still urgently need to add more donors to the database. We are thankful for every registration and you can still order your registration kit online atwww.dkms.org. Registering is simple and straightforward and you can become a potential lifesaver!

PROTECTING OUR DONORS

Patients around the world still urgently need blood stem cell transplants to survive. This is why we ask all of our donors to make themselves available if they are a match for a patient. The health and well-being of our donors is our number one priority and we consider every case on an individual basis. We will always do everything possible to ensure the safety of our donors.

We have implemented screening for the COVID-19 virus risks before entry to collection centers and before the start of a donation.

These measures serve to protect the donor as well as the recipient and the employees in the collection centers. Health experts have confirmed that there is currently no evidence that the COVID-19 virus can be transmitted via blood, bone marrow, or stem cell products.

We are grateful for every one of our incredible donors and for their commitment to providing patients with a second chance at life.

TRANSPORT OF BLOOD STEM CELL PRODUCTS

75% of all of our life-saving blood stem cell collections from DKMS donors travel across borders to patients in other countries. Due to the travel restrictions imposed by many countries because of the COVID-19 virus, we are faced with additional challenges in ensuring patients receive their transplant.

When it comes to transplants, time is crucial and we are determined to find solutions to be able to provide patients in need with their transplant. We are joining forces with other members of the international transplant community and national and international authorities in order to overcome these challenges. Despite the added difficulties that we are facing at the moment, as always, we are determined to overcome all barriers in order to provide as many patients as possible with a second chance at life.

FAQ's

1. WHY HAVE DONOR DRIVES BEEN CANCELLED OR POSTPONED AND WHAT IS THE ALTERNATIVE?

In light of the increasing spread of the COVID-19 virus, DKMS is postponing all planned events and registration drives for new potential blood stem cell donors until further notice. DKMS sees itself with a special duty of care and with these measures specifically follows the recommendations of the Centers for Disease Control to protect of the population.

Blood cancer patients around the world are still in urgent need of bone marrow and blood stem cell transplants and many are still not able to find a matching donor. This is why DKMS continues to encourage everyone that is able to, to register as a blood stem cell donor and if required, to also make themselves available for a donation."We must not abandon any patient who is currently searching for a blood stem cell donor or waiting for a life-saving blood stem cell transplant. In this difficult situation, I urgently ask that everyone continues to make themselves available as donors. We are taking all precautions necessary to protect each and every one of our donors in the best possible way," said Dr. Elke Neujahr, Global CEO DKMS.

We are grateful for every registration and to enable everyone that is interested to be able to register, DKMS offers the possibility of virtual donor drives that gives initiators, families and friends the opportunity to host a virtual drive to add more potential lifesavers to the donor pool via our online platform which can be found by clicking herehttps://dkmsgetinvolved.org/virtual-donor-drive. With this capability, any planned on ground registration drives can take place digitally instead and potential donors, which are urgently needed, can still register. The links to the online registration drives can be shared via all channels.

As always, registering as a blood stem cell donor via our homepage atwww.dkms.orgis also possible. Anyone who is interested can easily order a registration kit to be sent to their home. With the help of three cotton swabs and clear instructions, as well as a consent form, every potential new donor can take a cheek swab themselves and send it via post back to DKMS. In the DKMS Life Science Lab the individual HLA characteristics (also: tissue characteristics) of the donor are then analyzed, allowing the potential donor to be registered in the DKMS database.

The difference between the online registration drives and the general online registration is that the online registration drives are linked to particular patient appeals and the number of donors can be tracked accordingly. However, in general, it doesnt matter how you register, you will always be available as a potential lifesaver for blood cancer and blood disorder patients searching for a matching donor all over the world!

2. AM I STILL ABLE TO REGISTER ONLINE IF I SUSPECT THAT I MAY HAVE OR DO HAVE COVID- 19?

If it has been confirmed that you have been infected with the COVID-19 virus or you are awaiting test results, you unfortunately will not be able to register until 3 months after the infection has passed.

3. I REGISTERED ONLINE AND HAVENT RECEIVED A CONFIRMATION, IS THERE A DELAY?

We ask anyone registering as a potential donor online for their understanding. Normally we send all registration kits that we receive to our lab within 24 hours, however we are currently waiting 7 days until we do this to ensure the protection of our staff handling the returned registration kits. Please be assured that the analysis of your sample and HLA characteristics that is required for us to add you to the register, will take place as soon as possible.

4. HOW WILL DKMS MAINTAIN THE SAFETY OF DONORS?

The health and safety of our donors is our highest priority. We will consider the circumstances of all of our donors who are asked to donate their bone marrow and blood stem cells, on an individual basis, especially regarding their travel to a collection center. Please be reassured that we provide the best and safest solution possible for our donors.

Unfortunately, donors who live in high risk areas have to be blocked for search requests, as they are currently not eligible to proceed with a donation. We also have implemented screening for the COVID-19 virus risks before entry to any collection center and before the start of a donation. These measures serve to protect the donor as well as the recipient and the employees in the collection centers. Health experts have confirmed that there is currently no evidence that the novel Coronavirus can be transmitted via blood, bone marrow, or stem cell products.

Please also understand that any planned collection may be postponed or cancelled due to the current situation. We will keep you informed about all developments. Regarding the transport of blood stem cell products to the respective transplant clinics, we are in regular and close contact with all parties involved as well as with all relevant national and international authorities and organizations, to ensure that all blood stem cell collections can reach the patients.

5. IS THERE AN INCREASED CHANCE OF DONORS CONTRACTING THE COVID-19 VIRUS DURING THE DONATION PROCEDURE OR PREPARATION FOR THE PR

There is no risk of contracting the COVID-19 virus as a result of a blood stem cell collection. The health and safety of our donors is our number one priority and we will always ensure all procedures are in place to protect their safety.

6. CAN DONORS POSTPONE THEIR DONATION AT THIS TIME?

The final decision to donate is always made by the actual donor. If you have been asked to donate and have any concerns, please contact your DKMS coordinator. We evaluate each case on an individual basis to find the best solution for all parties involved.

7. IS IT STILL SAFE FOR PATIENTS TO RECEIVE A TRANSPLANT?

Health experts have confirmed that there is currently no evidence that the novel Coronavirus can be transmitted via blood, bone marrow, or stem cell products.

8. HOW IS THE TRANSPORT OF COLLECTIONS FROM DONORS IMPACTED BY THE CURRENT TRAVEL RESTRICTIONS?

The majority of blood stem cell collections from DKMS donors travel across borders to patients in other countries. Due to the travel restrictions imposed by many countries we are in regular and close contact with all parties involved in the transport, as well as with the relevant national and international authorities and organizations. Despite the added difficulties that we are facing at the moment, we are, as always, determined to overcome all barriers in order to provide as many patients as possible with a second chance at life.

9. HOW IS DKMS RESPONDING TO THE CURRENT TRAVEL RESTRICTIONS IN THE US?

Due to the restrictions on entry into the USA, DKMS has been in contact with the World Marrow Donor Association (WMDA) and the National Marrow Donor Program (NMDP). Together, we obtained special permits for stem cell couriers from Germany and Europe to enter the USA.

10. HOW WILL THE SPREAD OF THE COVID-19 VIRUS AFFECT DKMS AND ITS OPERATIONS?

As with every organization across the world, DKMS faces challenges caused by COVID-19 and some of the potential impacts are still not yet known. The goal of DKMS remains the same as it always has been and that is, together with our outstanding team of donors and employees, to give as many patients as possible around the world a second chance at life, through a life-saving bone marrow and blood stem cell transplant. The management team of DKMS is working around the clock together with all DKMS employees and relevant stakeholders to achieve this goal.

11. HOW WILL DKMS RESPOND AS THE SITUATION EVOLVES?

A dedicated team made up of experts from relevant departments at DKMS is constantly monitoring and evaluating the ongoing situation and will act accordingly. We will continue to keep our donors and all stakeholders updated.

12. IS DKMS TESTING POTENTIAL DONORS DURING THE REGISTRATION PROCESS?

DKMS does not test potential donors who register with us for the COVID-19 virus. If you are confirmed to have the virus, we ask that you do not register with us for the next 3 months. For donors who are asked to donate we have implemented screening for the COVID-19 virus risks before entering any collection center and before the start of a donation. These measures serve to protect the donor as well as the recipient and the employees in the collection center.

13. IF I AM A POTENTIAL DONOR AND I HAVE QUESTIONS, WHO SHOULD I CONTACT?

If you have been contacted by DKMS as a potential donor and if you have any questions or concerns, you are encourage to contact your DKMS coordinator. As always, DKMS staff is there to help you through the process and answer any questions that you may have.

14. IS THERE A NEED FOR QUARANTINE OR TESTING OF STEM CELL PRODUCTS BEFORE TRANSPLANTATION?

Although SARS-CoV and MERS-CoV have been detected in blood, there have not been any reports of transmission from donor to recipient either in transfusion of blood products or cellular therapies. As there is no evidence of transmission via blood, bone marrow, or stem cell products DKMS endorses the recommendations of the regulatory agencies such as the FDA and AABB which currently do not recommend or require product testing or to quarantine the stem cell product. For more information, please visit:share.wmda.info.

If a patient is in need of a transplant, there is no need to wait or prolong the process by testing or quarantining the stem cell product. Planned transplantations can go ahead.

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Now More Than Ever, the Importance of Second Chances at Life - CSRwire.com

VANCOUVER, Washington, March 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that an additional three critically ill COVID-19 patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA).

The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients. The laboratory evaluation of the first four patients treated with leronlimab revealed that the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm (including IL-6 and TNF alpha) were much improved. The results of the three additional patients are expected this week.

Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented, The preliminary results observed in patients who were severely ill with COVID-19 and treated with leronlimab are encouraging. Although the data set is still small, we saw fairly rapid and positive laboratory responses in all 4 patients treated, and in three of the 4 patients these laboratory results were associated with a favorable clinical outcome. We eagerly await the results of additional patients treated under the FDAs emergency IND program, as well as the results of several randomized clinical trials about to start.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, We remain encouraged and hopeful that leronlimab will help patients from this devastating and relentless disease. We will aggressively pursue treatment for COVID-19 patients, and to explore leronlimabs role in helping to alleviate the impending burden of supply chain and institutional capacity issues.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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Three Additional Patients with Severe COVID-19 Treated with Leronlimab in New York Medical Center Bringing the Total to 10 Patients - Associated Press

Dailymail.co.uk

Adam Castillejo (pictured), 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancer.

The second person to be cured of HIV has revealed how he was more fearful of dying from cancer than Aids and considered ending his life at Dignitas.Adam Castillejo, 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancer.He remained anonymous until he decided he wanted to be seen as an ambassador of hope after struggling with his health for almost two decades.Mr Castillejo, who was born in Venezuela and moved to London in 2002, was diagnosed with blood cancer in 2012, having already lived with HIV since 2003.His last hope of cancer survival was a bone marrow transplant from a donor with HIV-resistant genes that could wipe out his cancer and virus in one fell swoop.But in a powerful interview with The Sunday Times,Mr Castillejo admitted that he was more fearful of dying from stage 4 Hodgkins lymphoma than Aids.Calling the second diagnosis another death sentence, the sou-chef revealed that he panicked because cancer can kill you faster than HIV.Adam Castillejo, 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancerMr Castillejo embarked upon a gruelling treatment regime that left him physically emaciated and pushed the Venezuelan to the mental edge.Both illnesses became one because you had to deal with the anti-retroviral medications not interfering with thechemotherapy regime and vice versa, he said.By the end of 2014, he said that he had given up on battling the two illnesses, and had made up his mind to end it all at Dignitas in Switzerland.Around this time,Mr Castillejo disappeared, and was found four days later outside London psychologically broken. He does not remember this period.Doctors gave him six months to live, before a switch flicked.At that time I accepted straight away, because what choice have I got? I would rather die fighting, he explained.Within days, he met with Dr Ian Gabriel at the Chelsea and Westminster Hospital, who advised that he could attempt a bone marrow transplant.The procedure in May 2016 meantMr Castillejo was cleared of both cancer and HIV.But he lost five stone and took 60 pills a day, revealing: I told my doctors there werent enough hours in the day to take all the medication I needed.Mr Castillejo, who was born in Venezuela and moved to London in 2002, was diagnosed with blood cancer in 2012, having already lived with HIV since 2003An American man treated in Germany 12 years ago called Timothy Ray Brown (pictured) the so-called Berlin Patient also survived the transplantHe also developed mouth ulcers which inhibited his ability to eat, and his anti-retroviral medication had to be crushed and washed down.Mr Castillejo also claimed that he felt victimised and guilty when he told people that he was suffering from HIV, saying: This is a punishment for you.The Venezuelan chef is the second person to have survived the life-threatening technique and come out the other side HIV-free.An American man treated in Germany 12 years ago called Timothy Ray Brown the so-called Berlin Patient also survived the transplant.He was put into an induced coma for six months, however.Experts have hailed the treatment as a milestone in the fight against HIV, but are urging caution when calling it a cure so early on.In the context of HIV infection, the term cure means there are no virus-carrying cells left.Anti-retroviral therapy is very effective at reducing the viral load in the blood of infected individuals so that it cannot be transmitted to others.Unfortunately, the Berlin and London Patients cases do not change the reality much for 37 million HIV patients.The treatment is unlikely to have potential on a wider scale because both Mr Castillejo and Mr Ray Brown were given stem cells to treat cancer, not HIV.Stem cell and bone marrow transplants are life-threatening operations with huge risks. Patients can suffer a fatal reaction if substitute immune cells dont take.In his private life, Mr Castillejo likes to walk the streets of Shoreditch and travel.Kat Smithson, director of policy at National AIDS Trust, said: We applaud the London Patient Adam Castillejo for sharing his unique experience of having his HIV cured following a bone-marrow transplant to treat cancer. Mr Castillejo has been through a long and extremely challenging journey with his health, within which HIV is just one part.His decision to speak about his experience without anonymity can only enrich our understanding of his experience on a human level, and we thank him for this.Theres still a great deal of stigma around HIV which can make it harder for people to access the services and support they need and for people to talk openly about HIV.His story helps raise much-needed awareness of HIV, but broader than that its a story about incredible resilience, determination and hope.How a stem cell transplant cured the Berlin and London Patients and how it can go badly wrongUsually, HIV patients expect to stay on daily pills for life to suppress the virus. When drugs are stopped, the virus roars back, usually in two to three weeksThe vast majority of humans carry the gene CCR5.In many ways, it is incredibly unhelpful. It affects our odds of surviving and recovering from a stroke, according to recent research.And it is the main access point for HIV to overtake our immune systems.But some people carry a mutations that prevents CCR5 from expressing itself, effectively blocking or eliminating the gene.Those few people in the world are called elite controllers by HIV experts. They are naturally resistant to HIV.If the virus ever entered their body, they would naturally control the virus as if they were taking the virus-suppressing drugs that HIV patients require.Both the Berlin patient and the London patient received stem cells donated from people with that crucial mutation.WHY HAS IT NEVER WORKED BEFORE?There are many reasons this hasnt worked, Dr Janet Siliciano, at the Johns Hopkins University School of Medicine, told DailyMail.com.1. FINDING DONORSIts incredibly difficult to find HLA-matched bone marrow [i.e. someone with the same proteins in their blood as you], Dr Siliciano said.Its even more difficult to find the CCR5 mutation.2. INEFFECTIVE TRANSPLANT LEADS TO CANCER RELAPSESecond, there is a risk that the bone marrow wont take.Sometimes you dont become fully chimeric, meaning you still have a lot of your own cells.This means they will not defeat the cancer if it returns again.3. THE OLD IMMUNE SYSTEM ATTACKS THE NEW ONEThe other most common reason this approach has failed is graft-versus-host disease: whenthe patients immune system tries to attack the incoming, replacement immune system, causing a fatal reaction in most.4. UNKNOWN QUANTITIESInterestingly, both the Berlin patient and the London patient experienced complications that are normally lethal in most other cases.And experts believe that those complications helped their cases.Timothy Ray Brown, the Berlin patient, had both his cancer returned and he developed graft-versus-host disease, putting him in a coma and requiring a second bone marrow transplant.The London patient had one: he suffered graft-versus-host disease.Against the odds, they both survived, HIV-free.Some believe that, ironically, graft-versus-host disease might have helped both of them to further obliterate their HIV.But there is no way to control or replicate that safely.

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Adam Castillejo 'feared dying of cancer more than Aids and considered ending it all at Dignitas' Daily Mail - westofthepond.com

In the past, an injury to the stifle joint of a horse may have certainly ended his or her career or usefulness. Now, with the ever-evolving science of veterinary medicine, afflictions to the joint have a much higher chance of being treated or even healed.

One of the reasons a stifle injury gives apprehension to horse owners is the complicated nature of the joint said Scott Cammack, D.V.M. He practices at Northern Hills Veterinary Clinic in Sturgis, South Dakota, with several other specialists.

Cammack explains that its treatment is much more involved than similar injuries. For example, an injury to the hock can often be resolved by fusing the bottom two joints (the hock consists of four total). Because it is a low-motion joint, the horse will still be sound and function after fusion.

The stifle, on the other hand, is a high-motion joint. Its got a lot of things going on in there. It doesnt have the capacity to be fused and still be sound. I would consider that they are more serious. They are more prone to long-term issues than a hock is, in my mind, he said.

According to Dr. Cammack, the stifle is anatomically similar to a human knee. All the parts are similar to your knee. Just as athletes injure their knees, they injure themselves. They have a patella, theyve got meniscuses, theyve got anterior and posterior cruciate ligaments, theyve got collateral ligaments. One major difference is that humans have one patellar ligament coming off the kneecap, while horses have three. Therefore, horses can have very unique issues.

One condition, often found in younger horses (aged 2-6) is the intermittent upward fixation of the patella or simply a catchy stifle. Dr. Cammack describes this condition: The locking mechanism of the stifle is inappropriately keeping the leg in the locked, extended position. They cant bend their leg and it only bends at the fetlock. That one is one that we treat in different ways. Sometimes, well do a procedure where we put a needle in the medial patellar ligament and we split it a little bit and cause it to thicken up and tighten up a little bit to help correct that. So thats a pretty simple procedure.

Another condition found in younger horses is OCD (osteochondrosis) lesions, a developmental issue. According to Dr. Cammack, they are cyst-like lesions on the bone. Some of them fill in and some require surgery. We saw one just the other day. A four year old had large cysts up in the bone. All they did was turn the horse out and waited. That one filled in on its own, but thats not common. Usually youre injecting the cyst or putting a screw across it or various treatments for something like that.

On the other hand, older horses may have very different afflictions in the joint. He said, In my mind, youre going to see more of the soft tissue injuries in your younger horses and more of the osteoarthritis in the older horses.

Older horses are going to be more prone to seeing arthritis in their stifle, which might be secondary to an injury it had had way back when. They injured a collateral ligament and it wasnt diagnosed, or they have some instability from ligament damage and then it healed some and they got by with it. Years down the road, youre seeing the arthritis, the osteoarthritis in there.

Stifle injuries are often seen in performance horses in various disciplines. When you start getting into any disciplines where theyre having to run hard, turn hard, stop hard, spin. We see it more in the reined cow horses and the reiners and the barrel horses, Dr. Cammack said. However, injuries can occur on the ranch or in other disciplines, as well. Certainly any horse can catch some bad ground or find a hole in the ground or something that can cause them injury.

Interestingly, younger horses may be more prone to injuries that occur in the arena. We are doing our futurities and so much heavy training on them when theyre young and they dont have the muscle memory and the skillset to have their leg in the right place at the right time with that amount of force on it.

Dr. Cammacks procedure for examining horses includes a flex test, where the joint is stressed momentarily to determine the location of any potential weaknesses in the joints. The end goal is to determine how to optimize the horses performance without masking any problems. If the horse deals with chronic issues, the typical injection of HA (hyaluronic acid), a type of steroid, may be administered, costing around $175.

For other injuries, different types of injections may do the trick. Theres certainly a lot more going on with regenerative medicine than there used to be, Dr. Cammack said. Using PRP (platelet-rich plasma) can help the joint heal itself. Youre taking the blood and processing it and pulling out platelet-rich plasma. Its going to have healing factors and certain proteins that can help the joint get better. This may cost around $250.

Theres another one called pro-stride, which is another form of PRP, but its a more concentrated form of PRP. Its more like $450. If youre getting into stem cells, that goes right up. We just pull the bone marrow or the fat, depending on which form were doing and we send it in. With that sample that we send in, we have to send $2,300 to the laboratory. That one can be in excess of $2,500 to do stem cells, Dr. Cammack said. Its an exciting area.

Cammack has devoted his professional career to the study of equines and particularly their joints and movement.

When I was in college, I started working at this clinic with Dr. Margie Jones. I developed a strong affinity for equine work and did a year internship with an equine surgeon in California, but he did a sports medicine practice and then I got in the deep pool of sports medicine and developed a deep love for it, he said.

More severe injuries to the stifle may involve surgeries, which range vastly in involvement and price.

This article serves as a brief overview of a very large field of veterinary study. Dr. Cammack devotes much of his practice and time to learning more about the equine, attending the yearly American Association of Equine Practitioners conferences, and expanding into regenerative medicine.

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Stifle injuries and treatments - Tri-State Livestock News

The development of bone marrow transplantation procedures is widely considered one of the greatest victories in the war against cancer. The vast majority of bone marrow transplant recipients are patients with various forms of blood cancers, such as leukaemia, lymphoma or multiple myeloma. A real game changer, bone marrow transplantation has boosted survival rates for some blood cancers from nearly zero to over 85%.

Unfortunately, however, patients receiving bone marrow transplants are at high risk of developing Graft versus Host Disease (GvHD), a life-threatening complication that occurs when the transplanted cells from the donor the graft identify the transplant recipient the host as foreign.

This triggers an immune reaction that can wreak havoc in the transplanted patients body as it is attacked by the donated cells. This can occur from just days (in the case of acute GvHD) up to months or years (for chronic GvHD) after the haematopoietic cell transplantation (HCT) procedure has taken place.

The mortality rate of acute GvHD is very high in the case of grade 4 GvHD, it is over 90%. The overwhelmingly positive preliminary response of patients to CBD in preventing and treating GvHD shown in early trials, could be the key to significantly decreasing the incidence of this terrible condition.

Before we go on, there is a distinction to be made between a transplant rejection, which occurs when the immune system of the transplant recipient rejects the transplanted tissue, as may be the case in liver or heart transplants, and GvHD, which occurs when the while blood cells in the donors reject the recipient.

There are two types of bone marrow transplant: autologous (from the patients own stem cells) and allogeneic (stem cells from a donor). It is in the latter where GvHD may occur.

GvHD from allogeneic bone marrow transplants can manifest itself in many forms and degrees; ranging from mild, moderate or severe, to potentially fatal for the patient. Acute GvHD can cause rashes and blistering of the skin, nausea, vomiting, abdominal cramps accompanied by diarrhoea, jaundice; and may attack the lungs, liver and eyes. It is often associated with chronic illness, infections, disability, reduced quality of life, and is a major cause of morbidity and mortality following HCT.

Researchers estimate that despite aggressive preventive measures with immunosuppressive treatments, 30% to 50% of transplanted patients whose donors were fully matching siblings and 50% to 70% of patients whose donors were unrelated to them develop some level of GvHD.

Though it may sound surprising, currently there are no FDA approved therapies for either the prevention or treatment of acute GvHD.

Enter Kalytera Therapeutics, a clinical-stage pharmaceutical company aiming to develop cannabidiol (CBD) for the treatment of serious diseases. The companys drug development expertise and intellectual property portfolio put it at the forefront in the development of CBD-based medicines for a range of important unmet medical needs. Currently, its resources are being focused mainly on mitigating the effects of GvHD following bone marrow transplantation.

Kalytera Therapeutics lead programme, in which we are evaluating CBD for the prevention and treatment of GvHD, is in late-stage clinical testing. Kalytera Therapeutics have an ongoing open label Phase 2 clinical study to evaluate the pharmacokinetic profile, safety and efficacy of CBD for the prevention of acute GvHD with encouraging preliminary results; we are currently approaching the end of cohort 2. A series of Phase 1 studies requested by the FDA, such as the effect of food intake on the absorption of oral CBD, have also been completed.

At this stage, Kalytera Therapeutics are ready to plan a meeting with the FDA to discuss the possibility of starting a pivotal study later this year. Following the approval of Epidiolex for Dravet Syndrome by GW Pharma, the FDA has encouraged that Kalytera apply for a 505(b)2 regulatory pathway, which provides manufacturers of some types of drugs to apply for FDA approval without performing all the work required in a new drug application.

Kalytera Therapeutics have also received a Fast Track Designation to aid in the development and expedite review of drugs intended for serious or life-threatening disease and addressing an unmet medical need, for the companys CBD products for prevention and treatment of acute GvHD. This could accelerate the approval process for these products.

The obvious first step in attempting to prevent GvHD is to find donor cells that match the genetics of the immune system of the transplant recipient as closely as possible. But even in the ideal case of the donors being a sibling, the patient still must rely on drugs specially developed to cause immunosuppression of the donor cells, through either T-cell depletion or drugs. Treatments usually used for this include methotrexate, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil and antithymocyte globulin (ATG), as determined by each medical team and institution.

When it comes to treating GvHD, the grafts immune cell activation needs to be suppressed with medication, so that donor-host immune tolerance can be established once again. Most patients are given corticosteroids, which directly suppress the donors immune cell attack on the hosts tissues. This also raises the risk of infection and the relapse of cancer.

As of now, there are guidelines but there is no standard treatment for either prevention or treatment of acute GvHD. Only 30% to 50% of patients with moderate to severe GvHD respond to corticosteroids, leaving many at risk of fatal outcomes. Everyone in the healthcare system should be aware that more research is necessary to discover better treatment options to reduce the rates of mortality and morbidity in transplantation patients.

The programme Kalytera is now implementing is based on previous Phase 2a clinical trials, which showed outstanding preliminary results in the prevention of the disease by giving patients CBD orally. In the first study, 48 patients received CBD for seven days prior to the bone marrow transplant procedure and for 30 days thereafter, as opposed to a group of 101 historical controls who had been given the usual GvHD prophylaxis and treated in the same BMT unit by the same medical team.

Remarkably, results showed none of the 48 patients had developed acute GvHD in the 30 days of treatment with CBD. Those who developed GvHD did so within a median time of 60 days, whereas the control group of 101 historical controls began to develop acute GvHD in a median time of 20 days only (ranging from nine to 137).

In the CBD treated group, the rates of grade 2 to grade 4 acute GvHD by day 100 were 12.1%, compared with 46% in the control. The rate of severe grade 3 to grade 4 was 5%, compared to 10% in the control. Equally important is the finding that CBD was also safe and well tolerated, with no severe adverse events attributed to its consumption. This is consistent with safety data previously reported on CBD administered to humans, even with three to four times higher doses and even when taken over extended periods of time.

In light of these encouraging initial results, it was decided to test the efficacy of a prolonged treatment covering 100 days: the time window in which acute GvHD usually occurs. In a second study, 12 patients were administered CBD at the same dose starting from seven days before the bone marrow transplant procedure until 100 days post-transplantation. No safety issues were observed here either and only one noncompliant patient, representing 8% of the CBD treatment group, developed acute GvHD; compared to a 46% incidence at the same institution in the historical group of 101 patients described above. This is despite the fact that the majority of the patients (10 out of 12) received stem cells from unrelated donors, including five patients who received stem cells from non-fully matched donors, which would normally increase their chance of developing GvHD.

In a third Phase 2a study, which was performed for treatment of already sick patients, 10 patients with acute GvHD, who were refractory to standard treatment with high dose steroids (only 60% of patients respond to first line therapy with high dose steroids), were administered daily doses of CBD for up to three months. Strikingly, nine of the 10 patients enrolled in the study responded to treatment, seven of them achieving complete remission of GvHD and two more achieving a near-complete response.

These results are impressive when we take into account that the 12-month mortality rate among patients with grade 3 and grade 4 GvHD who do not respond to steroids exceeds 60% and 80%, respectively. Indeed, these preliminary results compare favourably with the results of the historical control group of 29 patients with steroid-refractory grades 3 and 4 GvHD, among which 26 patients died from GvHD and its complications.

With a median follow-up period of 13 months, six patients were still alive. Two patients died from leukaemia relapses, and two patients died from GvHD-related infectious complications. No patient deaths were determined to be associated with CBD treatment. This underlines the urgency of developing a product that can prevent and treat GvHD.

On the list of the 10 most expensive medical procedures, allogeneic BMT ranked fourth; while autologous BMT, at less than half the outrageous cost, still made it to the eighth place. Depending on the country and institution, costs range from tens of thousands to hundreds of thousands of dollars per procedure. The need and incentive to increase the rate of success are indisputable.

The life-saving ability of Kalyteras CBD products for the prevention and treatment of acute GvHD, currently classified as an orphan disease, means the company has good chances of obtaining premium pricing for a course of treatment. Over 20,000 patients suffer from acute GvHD following bone marrow transplantation in the six major markets of the US, Germany, the UK, France, Spain and Japan every year.

According to the January 2018 Market Forecast Report by DelveInsight Perspective, the potential market for a successful drug for prevention and treatment of GvHD in the seven major jurisdictions of the US, Germany, France, Italy, Spain, the UK and Japan is estimated to be over $408m in 2018; and could grow to approximately $1.3bn by 2027.

Once Kalyteras CBD products are approved by the FDA, the company believes that treating physicians would not be expected to prescribe anything other than its approved formulation of CBD (as opposed to a non-approved CBD that might be available online or from other commercial sources), especially since patients are often in isolation in the intensive care unit. It is safe to assume that neither private insurance nor government provided healthcare reimbursement would be available for non-prescription generic CBD in the jurisdictions where Kalytera intends to market its CBD product.

Conducting proper, large scale clinical trials with CBD is of utmost importance. Although in some areas CBD seems to be generally safe in the broader healthy population, it can be harmful to some groups, such as young adults, women of childbearing age, pregnant women, children, people with known heart conditions or low blood pressure, and the elderly.

Despite all the hype about the multiple health benefits of cannabis-based products trumpeted by many (though not clearly stated due to possible risks of liabilities for unsubstantiated claims), so far only one CBD-based drug has received FDA approval for the treatment of two rare and serious types of epilepsy.

Contrary to popular belief and anecdotal evidence, CBD is not a biologically inert compound. Rather, CBD has a complex pharmacokinetic and pharmacodynamic profile similar to any other medication with the potential to interact with other medications and medical conditions. CBD is metabolised in the liver by enzymes responsible for metabolising a large percentage of other drugs. When taken concomitantly, CBD may reduce or neutralise the intended action of those other medications. Kalytera has completed drug to drug interaction testing in vitro and is now planning to start testing in healthy subjects.

CBD oil can have negative side effects too, such as drowsiness, drop in blood pressure when taken in large doses, being potentially harmful for people with low blood pressure. Other problems are dizziness or light-headedness, appetite changes, diarrhoea, hormonal changes, hypokinesia and resting tremor when used for epilepsy. In psychotic disorders it has side effects too, but they are milder than on other drugs used until today. It can benefit some Parkinsons patients, but not all of them.

Kalytera has a solid, experienced leadership team and very strong intellectual property portfolio. We have three issued US and European patents covering the use of CBD in the prevention and treatment of GvHD, as well as four orphan drug designations for the treatment and prevention of GvHD in the US and Europe.

Our promising preliminary results indicate we will be able to help BMT patients and their donated bone marrow get along better. This will greatly improve patients quality of life, productivity and life expectancy by keeping them GvHD free.

Dr Sari SagivStero Biotechs+972 36176173david@sela.co.il

Please note: Kalytera Therapeutics Inc. have recently acquired Stero Biotechs.

This article will appear in the second issue ofMedical Cannabis Network which will be available to read in April 2020.

Excerpt from:
Kalytera Therapeutics: improving bone marrow transplants with CBD - Health Europa

In severe cases, it can also cause deadly hardening of internal organs like the lungs

MADISON, Wis. A year ago, Chuck Beschta couldn't walk more than a few minutes without stopping to rest.

"Just going out and doing normal activities outside raking the lawn mowing the grass shoveling the driveway whatever;snow blowing, those became impossible."

After months of testing he was diagnosed with severe scleroderma, which was hardening his skin but even worse. it was hardening his lungs, making it hard to breathe.

Scleroderma is an autoimmune rheumatic disease where an overproduction of collagen produced in the body tissues.

But in severe cases, it can also cause deadly hardening of internal organs like the lungs, giving some patients little hope of surviving.

Chuck's case was getting more dire.

"He was getting worse despite the best therapy we had to offer," explained Dr. Kevin McKown, a rheumatologist at the University of Wisconsin Hospital in Madison

Dr. McKown recommended a stem cell transplant newly approved for scleroderma to reboot chucks immune system.

"There's a process by which they try to remove the autoreactive immune cells, the cells that are caught in the immune process and then they infuse that back in and hope that the body will basically take up and graft that immune system

Rheumatologists at University of Wisconsin Health tested the treatment since they have already been conducting bone marrow transplants for decades.

Surgeons take out a sample of the patient's bone marrow, isolate the stem cells, and use radiation and chemotherapy to clean out their immune system. The same stem cells are later injected back into the patient's immune system with the hope that new cells will grow and the system is rid of the bad ones.

The process is dangerous when the cells are taken out because the patient's immune system is more vulnerable, making infections more likely to occur.

Chuck saw almost immediate results. His skin was softer and his breathing improved.

He hopes his scleroderma has been cured.

"I think we can be optimistic and so far the people who have been followed out as far as 10 years out don't seem to be getting it back," said Dr. McKown.

After four and a half years, 79% of patients who underwent the treatment were alive without serious complications compared to 50% that were treated with the original drugs.

Without a transplant, less than half the patients, like Chuck, who have diffuse scleroderma and severe lung disease live 10 years past diagnosis. stem cell transplants are commonly used to treat leukemia and lymphoma, cancers that affect the blood and lymphatic system.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

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YOUR HEALTH: A rare disease that hardens the skin - WQAD.com

Evolutionary dynamics in hematopoiesis

Cells accumulate mutations as we age, and these mutations can be a source of diseases such as cancer. How cells containing mutations evolve, are maintained, and proliferate within the body has not been well characterized. Using a quantitative framework, Watson et al. applied population genetic theory to estimate mutation accumulation in cells in blood from sequencing data derived from nearly 50,000 healthy individuals (see the Perspective by Curtis). By evaluating how mutations differ between blood cell populations, a phenomenon known as clonal hematopoiesis, the researchers could observe how recurrent mutations can drive certain clonal lineages to high frequencies within an individual. The risk of specific mutations, some of which are associated with leukemias, rising to high frequencies may therefore be a function of cellular selection and the age at which the mutation originated.

Science, this issue p. 1449; see also p. 1426

Somatic mutations acquired in healthy tissues as we age are major determinants of cancer risk. Whether variants confer a fitness advantage or rise to detectable frequencies by chance remains largely unknown. Blood sequencing data from ~50,000 individuals reveal how mutation, genetic drift, and fitness shape the genetic diversity of healthy blood (clonal hematopoiesis). We show that positive selection, not drift, is the major force shaping clonal hematopoiesis, provide bounds on the number of hematopoietic stem cells, and quantify the fitness advantages of key pathogenic variants, at single-nucleotide resolution, as well as the distribution of fitness effects (fitness landscape) within commonly mutated driver genes. These data are consistent with clonal hematopoiesis being driven by a continuing risk of mutations and clonal expansions that become increasingly detectable with age.

The rest is here:
The evolutionary dynamics and fitness landscape of clonal hematopoiesis - Science Magazine

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Story continues

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

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Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Yahoo Finance

Washington University School of Medicinein St. Louis released a newstudyabout the effectiveness of immunotherapy based on the age of the cells used. The study, published in the journalDevelopmental Cell,showed that these natural killer cells seem to be more effective when they are young. Natural killer (NK) cells, as they're called, are used in immunotherapy to treat cancer using the body's immune cells or immune cells from a matched donor.

"We are trying to improve the effectiveness of immunotherapy for more patients," said senior author Christopher M. Sturgeon, Ph.D., an assistant professor of medicine.

Typically, NK cells used in investigational immunotherapy are adult and come from the patient or donor bone marrow. While these therapies can work, they don't work for everyone.

In contrast, young NK cells do not use the patient's cell or donor cells. These early NK cells, typically formed in the yolk sac in the early embryo, are instead able to be created with human pluripotent stem cells. They can be manufactured quickly by most academic medical centers, thus eliminating the time it takes to process patient's or donor's cells for typical NK cell therapy.

"This special source of natural killer cells has the potential to fill some of the gaps remaining with adult NK cell therapy. There is early evidence that they are more consistent in their effectiveness, and we would not need to process cells from a donor or the patient. They could be manufactured from existing cell supplies following the strict federal guidelines for good manufacturing practices. The characteristics of these cells let us envision a supply of them ready to pull off the shelf whenever a patient needs them," Sturgeon said.

Instudieswith mice using the lab-developed human pluripotent stem cells to create early NK cells, researchers found positive results. These cells were significantly better at degranulation than adult NK cells. Even cells from umbilical cord blood did not respond as well as the early NK cells. Additionally, early NK cells are a particular type of short-lived immune cell, meaning that even if the cells cause harm, they aren't in the body for very long. However, NK cells, in general, do not attack the body's healthy tissues significantly, unlike many T cell therapies.

"Based on their unique behavior alone, there is one small clinical trial of these cells that is ongoing. Now that we know how to manufacture them and how they work, it opens the door for more trials and for improving upon their function, " Sturgeon said.

More research will need to be put into understanding why these special cells only show up in the early embryo and where they go after.

The origin and why they work so well is still a complete mystery.

"We can only speculate at this point, but it's possible that during early embryonic development, when there is so much rapid cell division, these cells are there as a surveillance mechanism to protect against pediatric cancers or infection," he said.

In addition to the early NK cells, pluripotent stem cells also have the potential to bring about many other different cell types, creating more possibilities.

Here is the original post:
Study Shows Development of Young Cells Could be New Option in Cancer Care - BioSpace

A 40-year-old HIV patient has been declared cured after a promising treatment has left him with no active virus. The man, Adam Castillejo, was the subject of extensive research in early 2019 after doctors failed to find HIV in his body over an 18-month period after previously being diagnosed in 2003.

Castillejo, known by the nickname London Patient lived with the disease for many years, taking medicine to manage it since 2012. That same year he was diagnosed with Hodgkins Lymphoma and later endured a bone marrow transplant. That operation may have ultimately cured him of HIV and appears to have made him only the second person to ever be cured of the disease that causes AIDS.

As ScienceAlert reports, the bone marrow transplant that doctors performed on Castillejo used cells from a donor with a very special genetic quirk. The cells are thought to work against HIV in the body, but there was no guarantee that the transplant would provide any concrete benefits beyond treating the cancer.

However, it appears as though the decision to treat Castillejo with the unique stem cells worked in more ways than one and last year doctors announced they couldnt find the virus in his body after 18 months. At the time, they were hesitant to declare the London Patient cured, but after a new round of testing returned the same results, they are more confident that the active form of the virus has indeed been defeated.

This is a unique position to be in, a unique and very humbling position, Castillejo told the New York Times. I want to be an ambassador of hope.

While this sounds like incredible news and for Castillejo, it certainly is the treatment is not an option for everyone. With cancer limiting their options, doctors used the stem cell transplant as a last resort to keep him alive. Its a serious operation and one that was only performed because Castillejos condition was so dire.

Castillejo and the other HIV patient who had similar results, known as the Berlin Patient, may be uniquely fortunate. The doctors note that there are others who have had the same transplant performed but did not improve as rapidly as the others. There are obviously many factors at work here and as exciting as it is to see a second person cured of this terrible disease, theres a lot more work to be done before we can say HIV has been truly beaten.

Read the original post:
HIV patient appears to be cured after stem cell treatment - New York Post

A second patient has been cured of HIV after undergoing stem cell transplant treatment, doctors said Tuesday, after finding no trace of infection 30 months after he stopped traditional treatment.

The so-called "London Patient", a cancer sufferer originally from Venezuela, made headlines last year when researchers at the University of Cambridge reported they had found no trace of the AIDS-causing virus in his blood for 18 months.

Ravindra Gupta, lead author of the study published in The Lancet HIV, said the new test results were "even more remarkable" and likely demonstrated the patient was cured.

"We've tested a sizeable set of sites that HIV likes to hide in and they are all pretty much negative for an active virus," Gupta told AFP.

The patient, who revealed his identity this week as Adam Castillejo, 40, was diagnosed with HIV in 2003 and had been on medication to keep the disease in check since 2012.

Later that year, he was diagnosed with advanced Hodgkin's Lymphoma, a deadly cancer.

In 2016 he underwent a bone marrow transplant to treat blood cancer, receiving stem cells from donors with a genetic mutation present in less than one percent of Europeans that prevents HIV from taking hold.

He becomes only the second person to be cured of HIV after American Timothy Brown, known as the "Berlin Patient", recovered from HIV in 2011 following similar treatment.

Viral tests of Castillejo's cerebral fluid, intestinal tissue and lymphoid tissue more than two years after stopping antiretroviral treatment showed no active infection.

Gupta said the tests uncovered HIV "fossils" - fragments of the virus that were now incapable of reproducing, and were therefore safe.

"We'd expect that," he said.

"It's quite hard to imagine that all trace of a virus that infects billions of cells was eliminated from the body."

Researchers cautioned that the breakthrough did not constitute a generalised cure for HIV, which leads to nearly one million deaths every year.

Castillejo's treatment was a "last resort" as his blood cancer would likely have killed him without intervention, according to Gupta.

The Cambridge doctor said that there were "several other" patients who had undergone similar treatment but who were less far along in their remission.

"There will probably be more but they will take time," he said.

Researchers are currently weighing up whether or not patients suffering from drug-resistant forms of HIV might be eligible for stem cell transplants in future, something Gupta said would require careful ethical consideration.

"You'd have to weigh up the fact that there's a 10-percent mortality rate from doing a stem-cell transplant against what the risk of death would be if we did nothing," he said.

Castillejo himself said that the experience had prompted him to come forward and identify himself in order to help spread awareness of HIV.

This is a unique position to be in, a unique and very humbling position," he told The New York Times.

Sharon Lewin, an infectious disease expert at the University of Melbourne and member of the International AIDS Society, said Castillejo's case was "exciting".

"But we need to also place it in context - curing people of HIV via a bone marrow transplant is just not a viable option on any kind of scale," she said.

"We need to constantly reiterate the importance of, prevention, early testing and treatment adherence as the pillars of the current global response to HIV/AIDS."

Agence France-Presse

Read the rest here:
Second Person Declared 'Cured' of HIV, With No Trace of Infection After Nearly 3 Years - ScienceAlert

UPDATE:

SPOKANE, Wash. -- Life-saving cells for alocal father of six are on their way to him from Poland. His family has been panicked after a travel ban was put in place by the Polish Government. They say they were told the status of the transport was stalled, and with time slipping away, they needed immediate action.

Jared Weeks was diagnosed withAcute Myeloid Leukemia back in October. His wife Janet contacted 'Help Me Hayley' on Saturday. On Sunday morning, Janet got word that the cells were on their way. She reached out to many government officials and is still trying to sort how and who helped make this happen for her husband.

"I heard that relief in (my husband's) voice and that's all I needed," she said. "I'm so thankful to everyone who shared the story, sent us prayers. I felt it. I really did. People are so overwhelmingly beautiful."

Janet says her husband will have the stem-cell transplant on Tuesday.

"I will be traveling over to Seattle on Monday evening to be there for his 're-birthday,'" she said of the procedure. "I'm so grateful."

PREVIOUS COVERAGE:

SPOKANE, Wash. -- A local father of six desperately needs help receiving life-saving cells provided by an overseas donor. His family says his life depends on it.

His wife Janet sent our Hayley Guenthner this 'Help Me Hayley' request:

"Dear Help Me Hayley,

My children and I are desperate to save my husband. He was diagnosed with Acute Myeloid Leukemia on 10/15/2019 (on his 42nd birthday of all days) since then he has been in the hospital. At the beginning of February we started our journey to the west side of the state to be under the care of Seattle Cancer Care Alliance and to make a long story short, we are now in the transplant stage of his disease.

My husband, Jared Weeks, went inpatient to the University of Washington Medical Center (UWMC) on behalf of the Seattle Cancer Care Alliance. He started his myeloablative chemo regimen on March 10th with the expectation of receiving an Unrelated Allogeneic Peripheral Blood Stem Cell transplant. He had the highest dose of chemotherapy to eliminate his disease and replace his immune system with a 38-year-old female peripheral blood stem cell donation from Poland. Because of the travel ban put in place by the Polish Government in response to the outbreak of the Novel COVID-19 virus, it is becoming impossible to transport these LIFE-SAVING cells that have been extracted from my husband's donor and brought back to the United States. I have left messages for Senator Cathy McMorris-Rodgers, Governor Jay Inslee, Mayor Woodward and Senator Maria Cantwell. I was able to speak personally with State Senator Shelly Short who is passing on this to some of her contacts in the cabinet. I reached out to the Polish Government agency handling the travel ban restrictions and have spoken with an Overseas Citizen Services Safety Officer out of Krakow Poland at the US Embassy-State Department. The travel ban has been put in place but I have been told that roads are still open as well as trains and planes, but as of midnight tonight (not sure if our time or their time) the borders will be closed until March 25th, and maybe extended depending on the COVID-19 outbreak. The cells have been collected from the donor and we are desperate to get them here. Please help us!! God help us.

My husband, Jared Weeks, was diagnosed with Acute Myeloid Leukemia on October 15, 2019 and is in DIRE need of these stem cells to survive.

We need some assistance from the "powers that be" to get these life-saving stem cells to my husband in Washington State ASAP.

His life depnds on it."

There have many people offering to test to see if they are a local match for Jared. Unfortunately, the family doesn't have the kind of time required to find a new donor.

"They would need to go to bethematch.org , however, it is too late in the game to be a donor for Jared but there are hundreds of others that need this life-saving donation as well," Janet said. "The HLA TYPING that is done can take weeks to complete and for Jared, we don't have that kind of time."

Janet is currently in Spokane with their children. She said she is doing everything she can to stay strong for her husband.

"(Jared) is one heck of a dad," Janet said. "He is hardworking, loves the outdoors, fishing, boating and taking his kids on adventures. He is amazing to us and is the center of gravity for our rather large family. He has been through hell and back with this cancer, and is still trusting God completely."

Seattle Cancer Cancer Care Alliance sent KHQ a statement on Jared and other cancer patients relying on life-saving bone marrow transplants during the COVID-19 outbreak.

"The COVID-19 outbreak is an evolving and fluid situation, and the global medical community is collaborating to address the needs of people who are relying on bone marrow transplants for their treatment and survival.

"Seattle Cancer Care Alliance is evaluating every patient who is currently connected with an international or USA-based donor to ensure we have an alternative solution for their treatment should the need arise.

"We are committed to continuing to coordinate with the National Marrow Donor Program and the World Marrow Donor Association, along with donor representatives in various countries, to prevent potential disruptions of critical medical transport so that every cancer patient has access to the life-saving treatment they need.

"SCCA is dedicated to providing the highest-quality cancer care, and we take that responsibility very seriously. We continue to work very closely with our alliance partners -Fred Hutch, UW Medicine and Seattle Childrens- and sharing our approach and best practices with other transplant centers around the country who may face similar unprecedented challenges."

Read more from the original source:
HELP ME HAYLEY: Spokane father of six receiving life-saving cells from Poland donor - KHQ Right Now

Revolutionary Gene-Editing Tool

Cardiovascular or heart disease (CVDs) is the leading cause of death across the world. Heart attacks resulting due to CVDs can cause death, and severe damage to cardiac muscle a muscle that forms the wall of the heart in survivors. However, researchers claim that they have discovered stem-cell activated mechanisms that promote healing after a heart attack.

According to the study by researchers from Mayo Clinic, stem cells were found to reverse the damage and restore cardiac muscle back to its condition before a heart attack. Human cardiopoietic cells obtained from stem cells within the bone marrow were found to hone in on damaged proteins and reverse intricate changes that a heart attack caused.

"The response of the diseased heart to cardiopoietic stem cell treatment revealed development and growth of new blood vessels, along with new heart tissue," said Dr. Kent Arrell, first author of the study, in a statement.

For the study, the researchers examined the diseased hearts of mice. The hearts of mice that received human cardiopoietic stem cell therapy were compared with those of that did not. Nearly 4,000 cardiac proteins were identified using a data science technique to map proteins found in the cardiac muscle. Over 10 per cent of the discovered proteins were found to suffer damage as a result of a heart attack.

"While we anticipated that the stem cell treatment would produce a beneficial outcome, we were surprised how far it shifted the state of diseased hearts away from disease and back toward a healthy, pre-disease state," said Dr. Arrell.

While the organs in the human body have the ability to repair their damaged cells, they may be unable to restore the loss entirely, and this holds good for cardiac cells as well. Dr. Andre Terzic, senior author of the study, said: "The extent of change caused by a heart attack is too great for the heart to repair itself or to prevent further damage from occurring."

He explained that upon the administration of cardiopoietic stem cell therapy to mice, a partial or complete reversal of nearly two-thirds of the damage caused by a heart attack was noted. Around 85 per cent of all cellular functional categories struck by the disease responded favorably to the treatment.

According to the World Health Organisation (WHO), CVDs claim nearly 18 million lives every year, which translates to 31 per cent of all deaths. The findings of the study provide an improved understanding of the restoration of heart health using stem cells and provide a framework for wider utilization of stem cell therapy for the treatment of various conditions.

Stressing that the actual mechanism behind the repair of diseased organs by stem cells is poorly understood, Dr. Terzic added: "This study sheds light on the most intimate, yet comprehensive, regenerative mechanisms paving a road map for responsible and increasingly informed stem cell application."

Read the original here:
Stem cells can reverse damage caused by heart attack; repair mechanism discovered: Study - International Business Times, Singapore Edition

PERTH, Australia Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.

The company is in active discussions with various governments, regulatory authorities, medical institutions and pharmaceutical companies to implement these activities.

What people are dying of is acute respiratory distress syndrome, which is the bodys immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs, Mesoblast CEO Silviu Itescu told BioWorld.

Were going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesnt destroy your lungs at the same time.

Recently published results from an investigator-initiated clinical study conducted in China reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients with severe COVID-19 pneumonia.

We have now looked at our own data in lung disease in adults where half the patients had the same kind of inflammation in the lungs as you get with coronavirus, and our cells significantly reduced the inflammation and significantly improved lung function, Itescu said, noting that he is awaiting emergency use authorization to treat patients under a clinical trial protocol.

In a post-hoc analyses of a 60-patient randomized controlled study in chronic obstructive pulmonary disease (COPD), remestemcel-L infusions were well-tolerated, significantly reduced inflammatory biomarkers, and significantly improved pulmonary function in those patients with elevated inflammatory biomarkers.

Since the same inflammatory biomarkers are also elevated in COVID-19, those data suggest that remestemcel-L could be useful in the treatment of patients with ARDS due to COVID-19. The COPD study results have been submitted for presentation at an international conference, with full results to be submitted for publication shortly.

Mortality in COVID-19-infected patients with the inflammatory lung condition is reported to approach 50% and is associated with older age, co-morbidities such as diabetes, higher disease severity, and elevated markers of inflammation.

Current therapeutic interventions do not appear to be improving in-hospital survival, and remestemcel-L has potential for use in the treatment of ARDS, which is the principal cause of death in COVID-19 infection.

Itescu said he didnt know of any other stem cell companies that were doing this. He said that other companies could try the approach from a research perspective but that Mesoblast has all the patents locked down.

The companys intellectual property portfolio encompasses more than 1,000 patents or patent applications in all major markets and includes the use of MSCs obtained from any source for patients with ARDS, and for inflammatory lung disease due to coronavirus (COVID-19), influenza and other viruses.

Remestemcel-L is being studied in numerous clinical trials across several inflammatory conditions, including in elderly patients with lung disease and adults and children with steroid-refractory acute graft-vs.-host disease (aGVHD).

Mesoblasts stem cell therapy is currently being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory aGVHD. The company submitted the final module of a rolling BLA in January.

Remestemcel-L is being developed for rare pediatric and adult inflammatory conditions. It is an investigational therapy comprising culture-expanded MSCs derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions.

The stem cell therapy is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues, according to Mesoblast.

Read this article:
Australia's Mesoblast plans to evaluate its stem cell therapy in patients infected with COVID-19 - BioWorld Online

Although most of the news from the world of health and medicine has been quite bleak lately, there are still major strides being made in the sector in an effort to combat the worst illnesses that plague humankind. One such stride was just announced, and its certainly worth celebrating: A second person has been cured of HIV.

In a study published in the medical journal, The Lancet, which comes via Medical News Daily, researchers in London say theyve been able to cure a patient of HIV; meaning the patient tested negative for HIV for an extended period of time (30 months as of March, 2020) despite the lack of antiretroviral therapy.

The person whos been cured, Adam Castillejo, was formerly known only as the London patient in order to protect his identity. But Castillejo, who lives in London, came forward recently, and said that he aims to be an ambassador of hope.

The first person to be cured of HIV, Timothy Ray Brown, an American known originally as the Berlin patient, revealed his identity in 2010, saying that I wanted to do what I could to make [a cure] possible. My first step was releasing my name and image to the public. Brown lived and was treated in Berlin. Incidentally, he is technically the second Berlin patient because the results from treatment of the first one are debatable.

AIDS Policy Project with Timothy Ray Brown (third from left with sunglasses). Griffin Boyce.

Castillejo, as well as Brown, were cured of HIV not by antiretroviral medications, which are often able to drastically mitigate the effects, and transmission rate of, HIV, but rather by stem cell transplants from donor bone marrow. Both Castillejo and Brown hadand may still have, that is unclearcancer along with HIV, and were treated with the stem cell transplants primarily to tackle the former disease. (It seems in Castillejos case doctors and researchers were hoping to cure both simultaneously.)

Both Brown and Castillejo underwent a procedure known as a Hematopoietic stem cell transplantation (or HSCT), which involves injecting bone marrow stem cells from a donor, whos often times a parent or sibling, into the recipients bloodstream. Castillejos HSCT treatment was different from Browns, as well as many others, because it was performed with cells that expressed the CCR5 gene.

A video from the MD Anderson Cancer Center that gives a brief outline of how bone marrow stem cell transplants work.

In Castillejos case, stem cells with genomes that express the CCR5 gene were selected because of the fact that it allows for the production of the CCR5 protein: a protein that makes people far more resistant to HIV-1, which accounts for the vast majority of global HIV infections.

While Castillejo received stem cells that did express the CCR5 gene, Brown did notat least according to the study in The Lancet. In fact, according to a 2017 article in New Scientist (which says that Brown received cells with a mutated CCR5 gene, rather than an unexpressed CCR5 gene), some experts believe the curing of Browns HIV was actually due to a potential side effect of his procedure, known as graft-versus-host disease. According to New Scientist, these experts believe that the donor cells attacked Browns native, HIV-infected immune cells, subsequently killing off the virus.

In Castillejos case, on the other hand, it seems there was no graft-versus-host issue that could account for his diminishment of HIV infection levels beyond whats expected to be detectable. Instead, the authors of the study say that one of the implications here is that the Long-term remission of HIV-1 can be achieved utilizing these kinds of cells. The authors also say this method does not require total body irradiation, which would usually be required in cases like these to weaken a recipients immune system in order to allow them to accept donor cells.

An HIV-infected T cell. NIAID

Unfortunately, it seems the treatment that cured Castillejo of HIV is a nonstarter when it comes to mass deployment. There are fatal side effects associated with HSCT, with host-versus-graft chief among them, and doctors say that it should only be performed when there are no other options left.

Prof. Ravindra Kumar Gupta from the University of Cambridge in the U.K., the lead author of the study, told Medical News Daily that [Its] important to note that this curative treatment is high risk and only used as a last resort for patients with HIV who also have life threatening hematological [blood] malignancies.

But Gupta and the other authors of the study still appear to be optimistic that this stands as a proof-of-concept for the idea of using CCR5 gene editing to cure HIV on a larger scale. They warn in their study, however, that several barriers, including the need for increased gene editing efficiency and a lack of robust safety data, still stand in the way of something that could be used as a scalable strategy for tackling HIV.

What do you think about this method of treating HIV? Do you think gene editing will play a big role in curing HIV, or do you think there are other, more promising treatments worth pursuing instead? Let us know your thoughts in the comments.

Feature image: C. Goldsmith / Eliot Lash

More:
A Second Person Has Been Cured of HIV - Nerdist

By: Cobey Bartels

Date: 16.03.2020

Friend of Owner//Driver and owner of the iconic Filthy White 4000 we covered last year, Mick Moo Lake, was diagnosed with cancer on Christmas Eve.

Mick and Mel Lake, with 'Filthy'

Since the devastating news, Mick and his wife Mel have been struggling to balance treatment and operating their business Truckin Stainless setting up a GoFundMe page to help cover the costs of hospital care.

Mick has Double Myeloma, a form of cancer that develops from plasma cells in the bone marrow, and has been receiving ongoing treatment since New Years Eve.

In 10 weeks Mick is having a Stem Cell Blood Transfusion, which will put him out of work for at least a month and will put significant strain on his business and familys livelihood.

At the time of writing, the GoFundMe page has raised $3,195 and Mick and Mel say the money will go towards covering the cost of treatment and help keep their business afloat.

Mick has been working through the treatment, where possible, to keep Truckin Stainless kicking along with the help of his good mate Steve who travelled down from Mackay to help lighten the load.

"He heard about what was going on when he was down here at the time, and he decided to stay and help while I was getting treatment," Mick says.

"Ive been working through it, going to hospital for treatments then back to the workshop - i havent stopped.

"In respect of all the wonderful people that have had to endure this terrible disease, we understand that asking for donations seems a bit steep, but if you would like to donate please do so, or think to donate to any cancer foundation," he says.

You can donate or find out more HERE.

You can also follow our updates by liking us on Facebook.

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Moo trucks on through cancer battle - Owner//Driver

VANCOUVER, Washington, March 16, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company filed a modified IND and protocol for its Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting Coronavirus Disease 2019 (COVID-19). The modification came at the behest of the U.S. Food and Drug Administration (FDA) in response to the Company's filing of its IND and protocol for its Phase 2 clinical trial on March 9, 2020.

The modified protocol is a Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients with Coronavirus Disease 2019 (COVID-19) and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.

Jacob Lalezari, M.D., CytoDyn's Interim Chief Medical Officer commented: "We appreciate the FDA's timely input on protocol design and hope to start the treatment study in the very near future."

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said: "We are pleased with the new trial design and are rapidly sending supplies of leronlimab to the clinics to begin patient treatment."

With respect to the Company's press release issued on March 12, 2020, management announces the following correction: Patient #1 had missed one treatment of carboplatin and will continue to be treated with carboplatin and leronlimab. Additional updates about this patient will be included in the next Company update on all cancer patients.

About Leronlimab (PRO 140) The U.S. Food and Drug Administration (FDA) have granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH. Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is therefore conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additionalclinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Company's cash position, (ii)the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv)the Company's ability to enter into partnership or licensing arrangements with third parties, (v)the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Company's ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Company's clinical trials, (viii)the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

Read more here:
CytoDyn Files Modified IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140) and Advises...

The second person ever to be cleared of HIV has revealed his identity, saying he wants to be an ambassador of hope to others with the condition.

Adam Castillejo, the so-called London patient, was declared free of HIV last year, 18 months after stopping antiretroviral therapy following a stem cell or bone marrow transplant to treat blood cancer.

Castillejo, 40, went public on Monday in an interview with the New York Times and revealed he had been living with HIV since 2003.

In 2012 he was diagnosed with Hodgkin lymphoma and subsequently underwent a stem cell transplant. Crucially, the medical team picked a donor whose stem cells had two copies of a mutation that meant the white blood cells they developed into were resistant to HIV.

Timothy Brown, known as the Berlin patient and the first person to be cleared of the virus, underwent a similar treatment. However, while Brown and Castillejo had chemotherapy, only Brown had radiotherapy as part of his cancer treatment.

Last year it emerged the procedure had not only successfully treated the cancer, but that Castillejo was in remission for HIV as well. However, he chose to remain anonymous at the time.

I was watching TV and its like, OK, theyre talking about me, he told the New York Times. It was very strange, a very weird place to be.

Now Castillejo has decided to reveal his identity because he wants his case to be a cause for optimism. This is a unique position to be in, a unique and very humbling position, Castillejo said. I want to be an ambassador of hope.

Stem cell transplants are not suitable for most people with HIV because they involve a serious and invasive procedure that carries risks.

However, drug advances mean people who are HIV positive can take a pill every day to reduce their levels of the virus, preventing transmission and helping them to live a long and active life.

Prof Ravindra Gupta, the first author of the new study from Cambridge University, said Castillejos case was important: It is a second case of cure,. It means the first one wasnt an anomaly or a fluke.

This article was amended on 10 March 2020. An earlier version was wrong to say that Adam Castillejo had acute myelogenous leukaemia. This has been corrected to say he was diagnosed with Hodgkin lymphoma.

View post:
Second person ever to be cleared of HIV reveals identity - The Guardian

NEW YORK, March 10, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited(Nasdaq: MESO; ASX:MSB) today announced that it plans to evaluate its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the United States, Australia, China and Europe. The Company is in active discussions with various government and regulatory authorities, medical institutions and pharmaceutical companies to implement these activities.

Mortality in COVID-19 infected patients with the inflammatory lung condition acute respiratory distress syndrome (ARDS) is reported to approach 50%, and is associated with older age, co-morbidities such as diabetes, higher disease severity, and elevated markers of inflammation.1 Current therapeutic interventions do not appear to be improving in-hospital survival.1

Remestemcel-L has potential for use in the treatment of ARDS, which is the principal cause of death in COVID-19 infection.1 This is supported by recently published results from an investigator-initiated clinical study conducted in China which reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients with severe COVID-19 pneumonia.2

Additionally, in post-hoc analyses of a 60-patient randomized controlled study in chronic obstructive pulmonary disease (COPD), remestemcel-L infusions were well tolerated, significantly reduced inflammatory biomarkers, and significantly improved pulmonary function in those patients with elevated inflammatory biomarkers. Since the same inflammatory biomarkers are also elevated in COVID-19, these data suggest that remestemcel-L could be useful in the treatment of patients with ARDS due to COVID-19.The COPD study results have been submitted for presentation at an international conference, with full results to be submitted for publication shortly.

Remestemcel-L is being studied in numerous clinical trials across several inflammatory conditions, including in elderly patients with lung disease and adults and children with steroid-refractory acute graft versus host disease (aGVHD).3-5 This product candidate is currently being reviewed by the United States Food and Drug Administration (FDA) for potential approval in the treatment of children with steroid-refractory aGVHD.

Remestemcel-L Remestemcel-L is being developed for rare pediatric and adult inflammatory conditions. It is an investigational therapy comprising culture-expanded MSCs derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

Intellectual PropertyMesoblasts intellectual property (IP) portfolio encompasses over 1,000 patents or patent applications in all major markets and includes the use of MSCs obtained from any source for patients with acute respiratory distress syndrome (ARDS),and for inflammatory lung disease due to coronavirus (COVID-19), influenza and other viruses. Additionally, these patents cover Mesoblasts manufacturing processes that yield industrial-scale cellular medicines.This IP position is expected to provide Mesoblast with substantial commercial advantages as it develops its product candidates for these conditions.

References1. Liu Y et al. Clinical features and progression of acute respiratory distress syndrome in coronavirus disease 2019. Medrxiv 2020; https://doi.org/10.1101/2020.02.17.200241662. Leng Z, et al. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia[J]. Aging and Disease, 10.14336/AD.2020.02283. Kurtzberg J et al. Annual Meeting of the American Society for Transplantation Cell Therapy, 2020.4. Chaudhury S et al. A Phase 3 Single-Arm, Prospective Study of Remestemcel-L, Ex-Vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Steroid Refractory Acute GVHD in Pediatric Patients. Biol Blood Marrow Transplant 2018; 24:S119S290.5. Kurtzberg J et al. Allogeneic human mesenchymal stem cell therapy (remestemcel-L, Prochymal) as a rescue agent for severe refractory acute graft-versus-host disease in pediatric patients. Biol Blood Marrow Transplant. 2014 Feb;20(2):229-35.

About MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Mesoblast To Evaluate Anti-Inflammatory Cell Therapy Remestemcel-L For Treatment Of COVID-19 Lung Disease - BioSpace

For Mr. Castillejo, the experience was surreal. He watched as millions of people reacted to the news of his cure and speculated about his identity. I was watching TV, and its, like, OK, theyre talking about me, he said. It was very strange, a very weird place to be. But he remained resolute in his decision to remain private until a few weeks ago.

For one, his doctors are more certain now that he is virus-free. We think this is a cure now, because its been another year and weve done a few more tests, said his virologist, Dr. Ravindra Gupta of the University of Cambridge.

Mr. Castillejo also tested his own readiness in small ways. He set up a separate email address and telephone number for his life as LP, as he refers to himself, and opened a Twitter account. He began talking weekly with Mr. Brown, the only other person who could truly understand what he had been through. In December, Mr. Castillejo prepared a statement to be read aloud by a producer on BBC Radio 4.

After talking through his decision with his doctors, friends and mother, he decided the time was right to tell his story.

I dont want people to think, Oh, youve been chosen, he said. No, it just happened. I was in the right place, probably at the right time, when it happened.

Mr. Castillejo grew up in Caracas, Venezuela. His father was of Spanish and Dutch descent which later turned out to be crucial and served as a pilot for an ecotourism company. Mr. Castillejo speaks reverently of his father, who died 20 years ago, and bears a strong resemblance to him. But his parents divorced when he was young, so he was primarily raised by his industrious mother, who now lives in London with him. She taught me to be the best I could be, no matter what, he said.

As a young man, Mr. Castillejo made his way first to Copenhagen and then to London in 2002. He was found to have H.I.V., the virus that causes AIDS, in 2003.

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The London Patient, Cured of H.I.V., Reveals His Identity - The New York Times

Bone remodeling and regeneration are dependent on resident stem/progenitor cells with the capability to replenish mature osteoblasts and repair the skeleton.

Until now, it has been thought that stem cells for bone lie within the bone marrow and the outer surface of the bone. Many studies have described the existence of a network of vascular channels that helped distribute blood cells out of the bone marrow. However, none of the studies had proved the existence of cells within these channels.

A new study by the scientists from the UConn School of Dental Medicine has discovered the population of stem cells that reside along the vascular channels within the cortical bone and have the ability to generate new bone. These stem cells stretch across the bone and connect the inner and outer parts of the bone.

Lead investigator Dr. Ivo Kalajzic, professor of reconstructive sciences, said, This is a discovery of perivascular cells residing within the bone itself that can generate new bone-forming cells. These cells likely regulate bone formation or participate in bone mass maintenance and repair.

This is the first study that reports the existence of these progenitor cells within the cortical bone that can generate new bone-forming cellsosteoblaststhat can be used to help remodel a bone.

To reach this conclusion, the scientists observed the stem cells within an ex vivo bone transplantation model. These cells migrated out of the transplant and started to reconstruct the bone marrow cavity and form new bone.

However, further study is required to determine the cells potential to regulate bone formation and resorption.

The study is presented in the journal Stem Cells.

Read more:
These new stem cells have the ability to generate new bone - Tech Explorist

10 things to know about stem cell therapy

New Delhi, March 3 (IANSlife) The usage of stem cells to cure or treat a disease or repair the injured tissue is defined as stem cell therapy. The best example of the stem cell treatment is seen in patients suffering from restoring the vision of the damaged eyes, grafting of the skin in severe burnt conditions. Stem cell treatments for brain or neural diseases like Parkinson''s and Alzheimer''s disease, multiple sclerosis, preventing heart strokes, curing diabetes, kidney disorders, autism, and spinal cord injuries are progressively making their way. Vipul Jain, CEO of Advancells and also a Serial entrepreneur, explains in detail the treatment, its uses, cost and effectiveness.

Q: What are stem cells?

Undifferentiated cells that are able to differentiate and transform into any type of cells of the body when and where needed. They have an enormous potential to repair, heal and regenerate. Stem cells come from blood, bone marrow, umbilical cord blood and adipose tissue.

Types of stem cell therapy

Autologous stem cell therapy: Patient receives stem cells from his/her own body

Allogeneic stem cell therapy: Patient receives the stem cells donated by another individual

Autologous stem cell therapy is better than allogeneic stem cell therapy as chances of mismatching are not there and they pose the minimum risk of immune rejection. Also, no side effects or adverse effects are seen as a person''s own blood cells are used. They start the healing process immediately in a natural way.

What is stem cell therapy?

The usage of stem cells to cure or treat a disease or repair the injured tissue is defined as stem cell therapy. Stem cells can be obtained from the bone marrow, adipose tissues etc. Due to their tremendous potential to prevent and to treat various health conditions and to repair the injured tissues global research investigation is continuously being done as to explore the maximum advantage of these cell lines.

The best example of the stem cell treatment is seen in patients suffering from restoring the vision of the damaged eyes, grafting of the skin in severe burnt conditions. Stem cell treatments for brain or neural diseases like Parkinson''s and Alzheimer''s disease, multiple sclerosis, preventing heart strokes, curing diabetes, kidney disorders, autism, and spinal cord injuries are progressively making their way.

What are the sources of stem cell?

Depending upon the disease, different stem cell source can be used in a specific condition. The procedure may involve the extraction of stem cells from adipose tissue-derived stem cells with the combination of PRP (Platelet-rich plasma) or can be obtained from bone marrow that can differentiate into progenitor cells that differentiate into various other tissues which can help in the therapy.

Procedure of stem cell therapy

The stem cells are isolated from the bone marrow or adipose tissues followed by their processing and enrichment under sterile conditions. These activated stem cells are placed back into the patient''s body at the target site for repairing the damaged tissue. It is necessary that the stem cells are injected in the specific area of injury as only then the desired results will be achieved.

Adipose stem cells are preferred over bone marrow stem cells as they are easy to isolate and contain a higher number of stem cells.

Stem cells injection

The stem cells injections are gaining much interest because it is devoid of the painful procedure, takes less time in comparison to a surgery, there are no host and recipient rejections as stem cells are harvested from the patient''s body itself and a targeted delivery system is available.

The stem cells obtained are processed in a sophisticated stem cell lab and after activation are inserted back into the host with the help of intravenous, intramuscular, intra-arterial, intradermal and intrathecal injections as per the requirement of the treatment process.

What is the use of anesthetics and why? Usually, local anesthetics are used during a stem cell procedure to numb the area but sometimes general anesthesia is also given while extracting the stem cells from bone marrow. But it is necessary to find out what anesthetic your doctor uses during orthopedic stem cell treatments.

A number of anesthetics have been found to kill the stem cells thus; the treatment''s end result will greatly depend on the use of anesthetics. Some anesthetics very well sync with the stem cell and hence, aid in the treatment.

How good are the processing techniques in the onsite labs?

Stem cells are to be extracted and processed in a clean room, under aseptic conditions maintaining a controlled environment. The doctor should explain the entire process and the number of viable stem cells infused into the patient during the process. Also, the precision of the injections to provide good quality of stem cells at the site of injury will help in better and faster recovery of the patient''s damaged area.

Duration and cost of the therapy

Cost of the treatment and its duration varies from one patient to another. The disease which needs to be cured, the severity, age factor, health condition, etc, define the duration of the therapy. One may respond during the treatment phase itself while the other may show results after a few sessions or weeks. Depending upon the disease diagnosed, the stem cells extracted, duration of the therapy, other adjuvants used in the process, the cost of the stem cell therapy can vary.

Follow-up visits

It is essential that after the stem cell therapy the patient should visit the stem cell doctor for recuperation therapies. The primary goals of such therapy is the prevention of secondary complications, analysis of recovery of motor, sensory and all the bodily functioning, psychological support/counseling for depression, mood swings or anxiety etc. and reintegration into the community.

There can be different sets of precautions which need to be followed at various steps for the recovery of the damaged tissues. The treatment and post treatment conditions may vary from person to person depending upon the disease and the severity.

Success rate of stem cell therapy

Stem cell therapy has shown results in treating serious ailments like leukemia, grafting tissues, autism, orthopedic conditions and skin problems etc. Stem Cell Therapy has been successfully used in the treatment of around 80 serious disorders.

Survival rates among patients who received stem cell treatment are significantly high, whether the cell donors are related or unrelated to them. With the ongoing research around the world, scientists are exploring new possibilities in which a number of life threatening diseases can be prevented and cured hence, the stem cells have proved to be promising in the near future as many aspects are yet to be revealed.

--IANS

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Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: IANS

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10 things to know about stem cell therapy - Outlook India

A new population of stem cells that can generate bone has been revealed by researchers, which they say could have implications in regenerative medicine.

A population of stem cells with the ability to generate new bone has been newly discovered by a group of researchers at the University of Connecticut (UConn) School of Dental Medicine, US.

The researchers present a new population of cells that reside along the vascular channels that stretch across the bone and connect the inner and outer parts of the bone.

This is a new discovery of perivascular cells residing within the bone itself that can generate new bone forming cells, said lead investigator Dr Ivo Kalajzic. These cells likely regulate bone formation or participate in bone mass maintenance and repair.

Stem cells for bone have long been thought to be present within bone marrow and the outer surface of bone, serving as reserve cells that constantly generate new bone or participate in bone repair. Recent studies have described the existence of a network of vascular channels that helped distribute blood cells out of the bone marrow, but no research has proved the existence of cells within these channels that have the ability to form new bones.

In this study, Kalajzic and his team are the first to report the existence of these progenitor cells within cortical bone that can generate new bone-forming cells osteoblasts that can be used to help remodel a bone.

To reach this conclusion, the researchers observed the stem cells within an ex vivo bone transplantation model. These cells migrated out of the transplant and began to reconstruct the marrow cavity and form new bone.

While this study shows there is a population of cells that can help aid formation, more research needs to be done to determine the cells potential to regulate bone formation and resorption, say the scientists.

According to the authors of the study: we have identified and characterised a novel stromal lineagerestricted osteoprogenitor that is associated with transcortical vessels of long bones. Functionally, we have demonstrated that this population can migrate out of cortical bone channels, expand and differentiate into osteoblasts, therefore serving as a source of progenitors contributing to new bone formation.

The results are published inSTEM CELLS.

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Stem cells that can grow new bone discovered by researchers - Drug Target Review

Stem cell research has been the subject of discussion and heated debate for many years. Much of the social and political drama surrounding stem cells is the result of misunderstanding what stem cells are, where they come from, and what they can do for those with injuries and diseases.

Working from a common set of facts is a great way to dispel controversy, however. Whether we fall into the pro-choice or pro-life camp, it is more than evident that supporting stem cell research, including the development of stem cell therapies, is very much a pro-life position to take.

Stem cells function essentially like raw materials for the body. Depending on instructions from the body (or researchers in laboratories), stem cells can become many other types of cells with specialized functions.

The daughters of stem cells either become new stem cells (self-renewal) or they become more specialized cells for use in specific areas of the body (differentiation). These specialized cells include brain cells, heart muscle cells, bone cells, blood cells and others.

There are several reasons why stem cells are the focus of some of the most important medical science research today:

This last avenue of medical research stem cell therapies is the most consequential as well as the most controversial, depending on your point of view. Understanding stem cell therapy and its divisiveness requires understanding where stem cells come from in medical research and why they have considerable palliative potential.

Stem cells come from one of these three sources:

Embryonic stem cells are the most controversial as well as the most important type of stem cells right now. Thanks to a low-information electorate and gross misinformation from within the government, embryonic stem cells remain mired in needless debate.

Despite the rhetoric, these cells arent harvested from slain newborns. Instead, they are carefully gathered from blastocysts. Blastocysts are three-to-five-day-old embryos comprised of around 150 cells. According to some religious-political arguments, blastocysts are potential human beings, and therefore deserve legal protection.

Embryonic stem cells are the most valuable in medical research because they are fully pluripotent, which means they are versatile enough to become any type of cell the body requires to heal or repair itself.

Adults have limited numbers of stem cells in a variety of bodily tissues, including fat and bone marrow. Unlike pluripotent embryonic stem cells, adult stem cells have more limits on the types of cells they can become.

However, medical researchers keep uncovering evidence that adult stem cells may be more pliable than they originally believed. There is reason to believe cells from adult bone marrow may eventually help patients overcome heart disease and neurological problems. However, adult stem cells are more likely than embryonic stem cells to show abnormalities and environment-induced damage, including cell replication errors and toxins.

The newest efforts in stem cell research involve using genetic manipulation to turn adult stem cells into more versatile embryonic variants. This could help side-step the thorny abortion controversy, but its also not clear at present whether these altered stem cells may bring unforeseen side-effects when used in humans.

More research is required to fully understand the medical potential of perinatal stem cells. However, some scientists believe they may in time become a viable replacement for other types of stem cells. Perinatal stem cells come from amniotic fluid and umbilical cord blood.

Using a standard amniocentesis, doctors can extract umbilical cord mesenchymal stem cells, hematopoietic stem cells, amniotic membrane and fluid stem cells, amniotic epithelial cells and others.

Among other things, stem cell therapy is the next step forward for organ transplants. Instead of waiting on a transplant waiting list, patients may soon be able to have new organs grown from their very own stem cells.

Bone marrow transplants are one of the best-known examples of stem cell therapy. This is where doctors take bone marrow cells and induce them to become heart muscle cells.

Stem cell-based therapies hold significant promise across a wide range of medical conditions and diseases. With the right approach, stem cells show the potential to:

As the FDA notes, there is a lot of hype surrounding stem cell therapy. Much of it is warranted, but some of it deserves caution.

According to the FDA, stem cells have the potential to treat diseases or conditions for which few treatments exist. The FDA has a thorough investigational process for new stem cell-based treatments. This includes Investigational New Drug Applications (IND) and conducting animal testing.

However, the FDA notes that not every medical entity submits an IND when they bring a new stem cell therapy to market. It is vital that patients seek out only FDA-reviewed stem cell therapies and learn all they can about the potential risks, which include reactions at the administration site and even the growth of tumors.

The FDA submitted a paper, Clarifying Stem-Cell Therapys Benefits and Risks, to the New England Journal of Medicine in 2017. Its goal is to help patients fully understand what theyre getting themselves into.

For now, a great deal more research is required before we begin deploying stem cell therapies on a larger scale. The only FDA-approved stem cell therapies on the market today involve treating cancer in bone marrow and blood. Some clinics claim their therapy delivers miracle-like cures for everything from sports injuries to muscular dystrophy, but there just isnt enough evidence yet to take them at face value.

Unfortunately, the religious and political climate makes this evidence difficult to achieve. In some parts of the United States, the hostility toward stem cell researchers and medical practitioners has reached dangerous new levels.

Republicans in Ohio and Georgia want to make it illegal for doctors to perform routine procedures on ectopic pregnancies. This condition is life-threatening for the mother and involves the removal of a nonviable embryo from the fallopian tube.

These laws wouldnt just outlaw ectopic pregnancy surgery in the name of potential human life. It would, in fact, require women to undergo a reimplantation procedure after the ectopic pregnancy is corrected by a physician. If this procedure was actually medically possible, it would be dangerous and unnecessary. Thankfully, it doesnt exist outside the nightmarish imaginations of some of the more extreme Christian lawmakers and Planned Parenthood demonstrators.

Acquiring embryonic stem cells from ectopic pregnancies would seem to be the least controversial way to go about it. Unfortunately, even that small step toward medical progress sees itself hampered by reactionary politics.

No matter how theyre acquired, however, the 150 or so cells in blastocysts are packed with medical potential. Its clear that further exploration down this road will unlock unprecedented scientific progress. It will also, almost certainly, save many times more potential life than even the most outlandish estimates of what the achievement will cost us to achieve. Abortions today are rarer and safer than ever, and the vast majority occur within eight weeks of conception.

The medical community is poised for a revolution here, using these and other nonviable embryos and blastocysts. But realizing that potential requires, among other things, that we collectively make peace with modern medicine and family planning.

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Despite Pro-Life Claims, Stem Cell Therapy Has Very Real Benefits and Should Be Accessible - Patheos

Steven Hodi Jr., the i3 Centers other PI, and director of Melanoma Center and the Center for Immuno-Oncology at Dana-Farber, and professor of medicine at Harvard Medical School (HMS), is leading the clinical cancer vaccine trial. He has been at the forefront of developing cancer immunotherapies using immune checkpoint inhibitors, a class of drugs able to re-activate tumor-destroying T cells that are muted in the tumor microenvironment. The funding for this center provides a unique opportunity to unite key investigators for translating fundamental advancements in immunology and biomedical engineering into highly synergistic approaches to improve the treatments for cancer patients, said Hod

Using both in vivo and ex vivo biomaterials-based approaches, the i3 Center aims to boost tumor-specific activities of cytotoxic T cells, by boosting different stages of the normal process by which T cells develop, and acquire anti-cancer activity. T cells normal development starts in the bone marrow where hematopoietic stem cells generate T cell progenitor cells. These migrate to the thymus to differentiate into nave T cells, which then travel further to lymph nodes. There, they encounter cancer-derived antigens presented to them by specialized antigen-presenting cells (APCs) that can activate T cells to recognize and eliminate cancer cells.

In relation to adoptive T cell therapies in which T cells are given to patients to fight their cancers, one team at the i3 Center will be led by Dana-Farber researchers Catherine J. Wu and Jerome Ritz, who along with Mooney, will develop and test biomaterials that can better mimic normal APCs in activating and directing the function of patient-derived T cells outside the human body, prior to their transplantation. Wu is chief of the Division of Stem Cell Transplantation and Cellular Therapies, and Ritz is executive director of the Connell and OReilly Families Cell Manipulation Core Facility at Dana-Farber.

We need to make efforts to enhance the ability of theimmune systemto recognizetumor cells. One directionmylaboratoryis taking makes use of innovative biomaterialsto help us to efficiently expandpolyclonaltumor-specificfunctionally-effectiveT cellsex vivoin a way that can be readily translated to theclinical setting. In our studies, we are currently focusing on melanoma and acute myeloid leukemia, said Wu, whose research interests include understanding the basis of effective human anti-tumor responses, including the identification and targeting of the tumor-specific antigens.

A second project explores the use of DNA origami, biocompatible nanostructures composed of DNA, to create cancer vaccines. DNA origami could provide significant advantages in presenting tumor-specific antigens and immune-enhancing adjuvants to APCs because the concentrations, ratios, and geometries of all components can be modulated with nano-scale precision to determine configurations that are more effective than other vaccination strategies. The project will be run by Wyss Institute Core Faculty member William Shih, Derin Keskin, lead immunologist at Dana-Farbers Translational Immunogenomics Lab, and Mooney.

In a third project, David Scadden, professor at Harvards Department of Stem Cell and Regenerative Biology, will collaborate with Mooney to build on their previous work. They will engineer biomaterials that recreate key features of the normal hematopoietic stem cell niche in the bone marrow. Such implantable biomaterials could help rapidly amplify T cell progenitor cells, and enhance T cell-mediated anti-cancer immunity. Scadden also is the Gerald and Darlene Jordan Professor of Medicine at Harvard University, and co-director of the Harvard Stem Cell Institute.

The i3 Centers investigators anticipate that it will stimulate additional cross-disciplinary concepts and research, due to the culture of continuous interactions, sharing of findings, data and samples between all investigators, as well strong biostatistical expertise provided by Donna Neuberg, a senior biostatistician broadly involved with exploring immune-modulating cancer interventions at the Dana-Farber.

This new i3 Center for cancer immunotherapy innovation really embodies how the Wyss Institute with its unparalleled capabilities in bioengineering and serving as a site for multidisciplinary collaboration, and can liaise with clinicians and researchers at our collaborating institutions to confront major medical problems and bring about transformative change, said Wyss Founding Director Donald Ingber. He is also theJudah Folkman Professor of Vascular Biologyat HMS and the Vascular Biology Program at Boston Childrens Hospital, and Professor of Bioengineering at SEAS.

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NIH-funded i3 Center formed to advance cancer immunotherapy - Harvard Gazette