Archive for the ‘Bone Marrow Stem Cells’ Category

With MLB spring training underway, there's plenty to talk about. USA TODAY Sports

Garrett Richards is aiming to pitch through a ligament tear via stem cell therapy and other recovery methods.(Photo: Rick Scuteri, USA TODAY Sports)

TEMPE, Ariz. Garrett Richards first thought when he found out about his torn elbow ligament last May was to schedule Tommy John surgery as soon as possible.

It made sense, considering the ligament-replacement procedure has become the standard fix for such injuries. Plus, the Los Angeles Angels ace was familiar with the operating room, having undergone surgery for a ruptured patellar tendon he sustained on Aug. 20, 2014, toward the end of a breakout season.

Richards knew how to handle the seemingly interminable months of rehab, and he wanted to get the clock started on his return.

But a conversation with Angels head physical therapist Bernard Li convinced Richards to consider other alternatives, and in mid-May he tried a relatively novel treatment in which stem cells taken from bone marrow in his pelvis were injected into the damaged area.

Richards did not pitch again the rest of the year except for a stint in the instructional league, but he has been back on the mound throwing bullpen sessions since the first day of the Angels camp and reported no problems.

This weekend, Richards anticipates pitching in a game for the first time since May 1, when his aching elbow forced him from a start after just four innings.

Its nice to know Ill be able to start the season this year and kind of pick up where I left off, Richards said.

A couple of lockers away, fellow starter Andrew Heaney had a different tale to tell.

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The promising left-hander also went down with a torn ulnar collateral ligament early in the season, after making only one start. Their ailments were the two biggest blows to an Angels rotation that was decimated by injuries, dooming the club to a 74-88 record and a fourth-place finish in the AL West.

Heaney also tried stem cell therapy, two weeks before Richards, both under the supervision of team doctor Steve Yoon. Heaneys ligament didnt heal, though, and after experiencing discomfort throwing following his rehab, he had Tommy John surgery July 1. He has been ruled out for the 2017 season.

They tell you its 50-50. It either works or it doesnt, Heaney said of the stem cell procedure. Obviously, me and Garrett are pretty much the proof of that rule.

Even with less-favorable odds than reconstructive surgery, which has an 80% success rate for returning to action and 67% for pitching 10 games or more, stem cell therapy is gaining acceptance as an option for pitchers with partial UCL tears. The recovery time is shorter 3-5 months instead of 12-18 and the treatment less invasive.

There are limitations. Biological approaches based on stem cells or platelet-rich plasma (PRP) wont repair a complete tear of the ligament. The location of the injury and its extent factor into the chances of success. And players whose ligament doesnt recover, then have to undergo surgery, extend their window of time for returning to action.

Even then, the idea of healing without going under the knife is becoming increasingly appealing. New York Yankees ace Masahiro Tanaka treated the small tear in his elbow ligament with PRP and rehabilitation in 2014, sitting out 10 weeks but coming back to pitch in late September.

Hes 26-11 with a 3.26 ERA over the last two seasons, raising the profile of PRP a procedure in which the players own blood is used to promote healing of the injury as a non-surgical alternative.

Now Richards looms as the test case for stem cell treatment to fix partial UCL tears, which make up about 60-70% of these injuries. If the hard-throwing right-hander can return to his old form he was a Cy Young Award candidate before his knee injury in August 2014 other pitchers in his situation are bound to at least consider the route he took.

I hope this opens another path for guys, Richards said. Obviously, if you can prevent being cut on and having surgery, thats the No. 1 priority. I hope guys dont just jump right into Tommy John, that they at least explore this option.

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Ageless veteran Bartolo Colon was the first pitcher widely known to have undergone stem cell therapy as he sought to recover from elbow and shoulder ailments in 2010. At the time, the ethics of the procedure were questioned, especially because the doctor who performed it, South Florida-based Joseph Purita, acknowledged using human growth hormone in previous treatments, though not in Colons.

Since then, the use of stem cells has become more mainstream. They are the focus of Yoons practice.

As more and more people start to use it, youre getting a better sense for what it can and cant do, Yoon said. Baseball definitely has opened up to it quite a bit, and as we see some of the successes like with Garrett, were getting a better understanding that theres a lot of potential here with these types of treatment.

Yoon calls stem cell therapy a super PRP because it combines the curative properties of that treatment with more healing agents, and said it can be used on tendon tears, muscle tears and strains and even to address degenerative joint disease.

However, much remains unknown about the benefits of stem cells. Lyle Cain, an orthopedist who has performed both Tommy John surgeries and stem cell treatments at the Andrews Sports Medicine & Orthopaedic Center in Birmingham, Ala., said most of the research has been anecdotal, not scientific.

We still dont have a good understanding even four or five years into it exactly what the stem cells do, what their method is, Cain said. The theory is theres probably a chemical reaction where it releases chemicals in the cell that help the healing process. The stem cells arent necessarily put in there with the thought theyre going to become ligament, but theres probably a cellular chemical mechanism that helps the healing response.

And as Heaney discovered, theyre not always effective. His tear was located farther down the arm, which reduced his chances of success with stem cell therapy. Richards was a better candidate because his injury, though deemed high grade, was located within the ligament, like a slit on a rubber band.

But because Heaney was looking at likely missing most or all of 2017 even if he had surgery right away, he decided to try stem cells. The timing of the injury plays a major role in whether pitchers contemplate alternatives to surgery, with the more conservative approach often recommended if it happens early in the season.

Heaney said he doesnt regret taking that route, and would have been upset if he had undergone the ligament-replacement operation right away, only to find out he could have returned to action quicker through another means.

Im glad it worked for him, he said of Richards. It would have been really awful if it hadnt worked for either of us. Then wed both look like idiots.

Their peers are paying attention. In a major league pitching community where about a quarter of its members have undergone Tommy John surgery, interest in the effectiveness of alternative cures is high.

The Los Angeles Dodgers Brandon McCarthy was not a candidate because his ligament tore clear off the bone, but said he had heard positive reports about stem cell treatment, not so much about PRP.

The Pittsburgh Pirates Daniel Hudson, a veteran of two Tommy Johns, is encouraged as well.

Its supposed to help repair the tissue. Before, ligaments just wont repair themselves, Hudson said. It might keep a lot of guys from going under the knife.

Thats Cains hope. He regularly treats UCL tears on high school, college and minor-league players with stem cells or PRP, but realizes theres heightened pressure on major leaguers to return to the field.

If more of them can do it without visiting an operating room, it would represent a major advancement for both the players and the industry.

I think overall the biologic treatment of these injuries will certainly progress and it will be somewhat the wave of the future, Cain said. There will be certain ligaments that are damaged enough that we dont have an answer; they have to reconstruct. But I think overall, if you look 15 years down the road, I suspect well be doing a lot more non-surgical treatment than surgical treatment.

Contributing: Gabe Lacques in Bradenton, Fla.

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All eyes on Garrett Richards, in hopes stem cells stave off Tommy John surgery - USA TODAY

February 27, 2017 Human mesenchymal stem cells were labeled for two epigenetic marks (green and red), and the images were analyzed to forecast the cell developmental fate. Credit: Joseph J. Kim

Scientists at Rutgers and other universities have created a new way to identify the state and fate of stem cells earlier than previously possible.

Understanding a stem cell's fatethe type of cell it will eventually becomeand how far along it is in the process of development can help scientists better manipulate cells for stem cell therapy.

The beauty of the method is its simplicity and versatility, said Prabhas V. Moghe, distinguished professor of biomedical engineering and chemical and biochemical engineering at Rutgers and senior author of a study published recently in the journal Scientific Reports. "It will usher in the next wave of studies and findings," he added.

Existing approaches to assess the states of stem cells look at the overall population of cells but aren't specific enough to identify individual cells' fates. But when implanting stem cells (during a bone marrow transplant following cancer treatment, for example), knowing that each cell will become the desired cell type is essential. Furthermore, many protein markers used to distinguish cell types don't show up until after the cell has transitioned, which can be too late for some applications.

To identify earlier signals of a stem cell's fate, an interdisciplinary team from multiple universities collaborated to use super-resolution microscopy to analyze epigenetic modifications. Epigenetic modifications change how DNA is wrapped up within the nucleus, allowing different genes to be expressed. Some modifications signal that a stem cell is transitioning into a particular type of cell, such as a blood, bone or fat cell. Using the new method, the team of scientists was able to determine a cell's fate days before other techniques.

"Having the ability to visualize a stem cell's future will take some of the questions out of using stem cells to help regenerate tissue and treat diseases," says Rosemarie Hunziker, program director for Tissue Engineering and Regenerative Medicine at the National Institute of Biomedical Imaging and Bioengineering. "It's a relatively simple way to get a jump on determining the right cells to use."

The approach, called EDICTS (Epi-mark Descriptor Imaging of Cell Transitional States), involves labeling epigenetic modifications and then imaging the cells with super resolution to see the precise location of the marks.

"We're able to demarcate and catch changes in these cells that are actually not distinguished by established techniques such as mass spectrometry," Moghe said. He described the method as "fingerprinting the guts of the cell," and the results are quantifiable descriptors of each cell's organization (for example, how particular modifications are distributed throughout the nuclei).

The team demonstrated the method's capabilities by measuring two types of epigenetic modifications in the nuclei of human stem cells cultured in a dish. They added chemicals that coaxed some of the cells to become fat cells and others to become bone, while another set served as control. Within three days, the localization of the modifications varied in cells destined for different fates, two to four days before traditional methods could identify such differences between the cells. The technique had the specificity to look at regional changes within individual cells, while existing techniques can only measure total levels of modifications among the entire population of cells.

"The levels are not significantly different, but how they're organized is different and that seems to correlate with the fact that these cells are actually exhibiting different fates," Moghe said. "It allows us to take out a single cell from a population of dissimilar cells," which can help researchers select particular cells for different stem cell applications.

The method is as easy as labeling, staining and imaging cells - techniques already familiar to many researchers, he said. As the microscopes capable of super resolution imaging become more widely available, scientists can use it to sort and screen different types of cells, understand how a particular drug may disrupt epigenetic signaling, or ensure that stem cells to be implanted won't transform into the wrong cell type.

Explore further: Super-resolution imaging can map critical cell changes several days sooner than current method

More information: Joseph J. Kim et al, Optical High Content Nanoscopy of Epigenetic Marks Decodes Phenotypic Divergence in Stem Cells, Scientific Reports (2017). DOI: 10.1038/srep39406

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Super resolution imaging helps determine a stem cell's future - Phys.Org

Kolkata: Joy knew no bounds for 42-year-old Nilesh Sinha, when he hugged his saviour, 27-year-old Sajat Jain. Mr Sinhacalls it the warmest and most meaningful hug of his life.

Two years ago, Mr Sinha was suffering fromAplastic Anemia, a rare disease in which the bone marrow and the hematopoietic stem cells that reside there are damaged. Only a stem cell transplant could have saved himfrom his deteriorating condition and Mr Jains were a perfect match.

The peripheral blood stem cell or PBSC transplant took place at Kolkatas Tata Memorial Centre in 2015. Last week, the two came face-to-face for the first time at an event organised by Datri, Indias largestadult unrelated blood stem cell donors registry, which aided the transplant between the two.

Mr Sinha said he was ecstatic to find the opportunity to say thanks to the man he owes his life to. Sajat is my childrens new superhero, he said.Mr Jain toocould not believe that his simple act saved someones life.

Mr Sinha told NDTV that he is sure that once people get to know about Mr Jain, they will also come forward to register themselves as stem cell donors and after them, the next generation will also get motivated.

Mr Jain, who runs a healthcare start-up, said that he became a donor while researching for his company and could save Mr Sinhas life just in time, after a donor backed out. He wants more young people to register so that someone in need can be benefited.

I was actually pretty excited. I know I was able to save someones life and not too many people can say that in their lifetime. When I actually saw his face, I remembered his previous condition and was delighted to see how fit he had become, Mr Jain told NDTV.

Kolkata has seen 300 successful stem cell transplants so far. Director of Tata Memorial Centre, Kolkata, Dr Mammen Chandy told NDTV that there is a need for more donors in India. When a donor asks me what is the risk of a donation, I would say, what is the risk of crossing the street outside my hospital and not being hit by a bus? he said.

In 2009, Datri came to the aid of people suffering from life threatening blood disorders like leukaemia, lymphoma, severe aplastic anemia, sickle cell disease, thalassemia among others. It started with 3,000 people pledging to donate stem cells and today there are 93,000 registered donors with them. With this small number of registered donors, however, the possibility of finding a match for an Indian anywhere in the world is very bleak.

Blood stem cells from a donor can give someone a second chance at life and a patient has 25 per cent chance of finding a match within the family. There are three sources of blood-forming cells used in transplants: bone marrow, peripheral blood stem cell or PBSC and umbilical cord blood collected after a baby is born.

The peripheral blood stem cell donation is a painless, non-surgical, outpatient procedure that involves only a needle in the arm vein, similar to platelet donation. However, if a marrow is requested, then it is a surgical procedure.

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Stem Cells Saved His Life. Two Years Later, He Met The Donor - NDTV

Shreveport, La. - Jasmine Sewell was diagnosed with bone caner in February of 2014. She and her fiance, Marcus Price, had planned their wedding for September of 2017 but moved up the date after Jasmine was given a prognosis in 2016 of less than a year to live.

Jasmine and Marcus were married February 11, 2017 and many of their guests gave a present to Jasmine by registering as bone marrow donors.

Jasmine has stopped responding to treatments and now needs a bone marrow or stem cell transplant to survive.

Be the Match signs people up to be bone marrow and stem cell donors but there is a shortage of minority donors. The match between the donor and recipient is largely based on genetics an ancestry so the likelihood of a non minority donor being able to help Jasmine is very slim.

The sign up is easy, just a cheek swab, and the donation of stem cells is a process similar to giving blood. Infant recipients can need actual bone marrow which is taken from the bone with a needle but the patient is sedated and most people only feel a bit sore after the procedure.

Jasmine is asking anyone not registered to sign up, and act as if it were their loved ones that needed the transplant.

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Vital need for minority bone barrow donors - Story - KTAL

In a significant advance in improving the safety of donor stem cell transplants, a major clinical trial led by researchers at Dana-Farber Cancer Institute and Brigham and Women's Hospital (BWH) has shown that a novel agent can protect against the most common viral infection that patients face after transplantation.

The results represent a breakthrough in a decade-long effort to identify an effective drug for the prevention of CMV infection in transplant patients that doesn't produce side effects that negate the benefit of the drug itself, the study authors said.

The findings, from an international phase 3 clinical trial of the drug letermovir for preventing cytomegalovirus (CMV) infection in transplant patients, will be presented at the 2017 Bone Marrow Transplant Tandem Meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Orlando, Florida, February 22, 2017.

The study, which involved 565 adult patients at 67 research centers in 20 countries, compared letermovir to placebo in preventing an active CMV infection following transplant with donor stem cells. The patients, who were undergoing transplant as treatment for blood-related cancers or other disorders, all carried a CMV infection from earlier in life that had been wrestled into dormancy by their immune system. Twenty-four weeks after completing up to 14 weeks of treatment, 61 percent of the patients receiving a placebo had developed a CMV infection serious enough to require treatment or had discontinued the trial. By contrast, only 38 percent of those treated with letermovir developed that level of CMV infection or did not complete the trial.

Unlike other drugs able to forestall active CMV infection in stem cell transplant patients, letermovir did so without producing unacceptable toxicities. Most of the side effects associated with letermovir were tolerable, including mild cases of nausea or vomiting, and some swelling, investigators found. Letermovir also conferred a survival benefit: at the 24-week mark, 15 percent of the placebo patients had died, compared to 10 percent of those receiving letermovir.

"For the first time, we seem to have a drug that is a true safe and effective preventive for CMV infection in stem cell transplant patients," said the study's lead author, Francisco Marty, MD, an infectious disease specialist at Dana-Farber and BWH. "Letermovir will allow many patients to avoid infection, usually with no or mild side effects, and seems to provide a survival benefit in the first six months post-transplant."

Transplantation of donor hematopoietic stem cells -- which give rise to all types of blood cells, including white blood cells of the immune system -- is used to treat blood-related cancers such as leukemia, lymphoma, and myeloma, as well as several types of non-cancerous blood disorders. Patients typically receive chemotherapy to wipe out or reduce the bone marrow, where blood cells are formed, followed by an infusion of donor stem cells to rebuild their blood supply and reconstitute their immune system.

While refinements in transplant techniques have sharply improved the safety of the procedure, the reactivation of CMV infection following a transplant has been a longstanding problem.

Infection with CMV, a type of herpes virus, is one of the most common viral infections in the world. In the United States, it's estimated that over 50 percent of people are infected before adulthood. In other parts of the world, infection rates can be significantly higher. The effects of CMV infection can range from no symptoms to a flu-like fever or mononucleosis ("mono") syndrome. Once the immune system has brought the infection under control, the virus persists unobtrusively in the body.

The jolt of a stem cell transplant -- the rapid erasure or diminishment of the immune system produced by pre-transplant chemotherapy, as well as measures to prevent graft-versus-host disease -- can give CMV a chance to reawaken and run amok before the newly reconstituted immune system takes hold. In the early years of bone marrow transplant therapy, 60 to 70 percent of transplant recipients developed CMV infection, Marty recounts. Of those, 20 to 30 percent contracted CMV pneumonia, and of those, 80 percent died of the disease.

In previous clinical trials, several drugs aimed at preventing CMV infection in stem cell transplant patients either were not effective or produced intolerable side effects. In the absence of safe preventive drugs, physicians worked out a "surveillance" approach in which they provide treatment only when patients develop CMV infection, and only for a short period of time. This strategy has largely been a success: patients now have just a 2 or 3 percent chance of getting CMV disease affecting the lungs or other organs. Still, the often harsh side effects of current drugs were reason to continue the search for a useful preventive agent.

Letermovir works by a different mechanism from previously tested agents, which block an enzyme known as DNA polymerase, which viruses use to duplicate their DNA. (Human cells use the same process to replicate their own DNA.) By contrast, letermovir blocks a process by which CMV is "packaged" inside infected cells -- a wrapping that allows it to go on and infect other cells. The fact that this process does not occur in human cells may explain in part why letermovir usually gives rise to only mild side effects, researchers say.

In the trial, patients received letermovir or a placebo beginning an average of nine days after transplant. "The goal was to suppress the virus before it has a chance to become active," Marty remarked. "The results of this trial offer encouragement that letermovir can offer a new strategy for donor stem cell transplant patients in preventing the emergence of CMV infection following transplant."

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New antiviral drug cuts cytomegalovirus infection, improves survival in patients undergoing donor stem cell transplant - Science Daily

February 24, 2017

An international team of researchers, funded by Morris Animal Foundation, has shown that adipose (fat) stem cells might be the preferred stem cell type for use in canine therapeutic applications, including orthopedic diseases and injury.

Researchers at the University of Guelph, University of Western Ontario and Aarhus University, Denmark, ran a battery of tests comparing the physiology characteristics of stem cells derived from adipose tissue versus bone marrow. They found that stem cells from both sources had similar functional properties, including tissue generation and immunomodulating capabilities (ability to adjust immune response), but adipose stem cells grow at a faster rate than bone marrow stem cells. Harvesting adipose stem cells also is less invasive than harvesting bone marrow. The study recently was published in PLoS ONE, an online scientific journal.

In the last decade, the use of stem cell therapy in animals and humans has dramatically increased. In dogs, stem cell therapy is used in the treatment of a variety of orthopedic diseases and injuries. Stem cells are harvested from either fat tissue or bone marrow, purified and grown in culture, then placed back in the patient.

Given the ease of harvesting, adipose tissue has become the site of most stem cell collections in canine patients. But questions persisted regarding the differences between these two sources of stem cells, and which is better suited to therapeutic applications.

"Faster proliferation along with the potential for a less invasive method of their procurement makes them (adipose stem cells) the preferred source for canine mesenchymal stem cells," concluded the research team.

Explore further: Stem cell therapy trial at Sanford first of its kind in US for shoulder injuries

More information: Keith A. Russell et al, Characterization and Immunomodulatory Effects of Canine Adipose Tissue- and Bone Marrow-Derived Mesenchymal Stromal Cells, PLOS ONE (2016). DOI: 10.1371/journal.pone.0167442

Journal reference: PLoS ONE

Provided by: Morris Animal Foundation

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Study shows adipose stem cells may be the cell of choice for therapeutic applications - Medical Xpress

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Two years ago, Doreen Flynn of Lewiston, Maine, won her case against the U.S. government, successfully arguing that bone-marrow donors should be able to receive compensation.

Flynn, a mother of three girls who are afflicted with a rare, hereditary blood disease called Fanconis anemia, has a strong interest in bone-marrow transplantation. At the time of the court ruling, her oldest daughter, Jordan, 14, had already received a transplant, and one of the younger twins, Jorja, was expected to need one in a few years.

Locating a marrow donor is often a needle-in-a-haystack affair. The odds that two random individuals will have the same tissue type are less than 1 in 10,000, and the chances are much lower for blacks. Among the precious few potential donors who are matched, nearly half dont follow through with the actual donation. Too often, patients dont survive the time it takes to hunt for another donor.

Allowing compensation for donations could enlarge the pool of potential donors and increase the likelihood that compatible donors will follow through. So the ruling by a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit was promising news for the 12,000 people with cancer and blood diseases currently looking for a marrow donor. (James F. Childress, an ethicist at the University of Virginia, and I submitted an amicus brief in the case.)

Soon after the verdict, Shaka Mitchell, a lawyer in Nashville, Tennessee, and co-founder of the nonprofit MoreMarrowDonors.org, began collecting funds to underwrite $3,000 donor benefits, which were to be given as scholarships, housing allowances or gifts to charity.

Mitchell also invited a team of economists to evaluate the effects of the ruling on peoples willingness to join a registry and to donate when they are found to be a match. The researchers were to specifically assess whether cash payments would be any more or less persuasive than noncash rewards or charitable donations.

Now comes the bad news. On Oct. 2, the U.S. Department of Health and Human Services proposed a new rule that would overturn the Ninth Circuits decision. The government proposes designating a specific form of bone marrow -- circulating bone-marrow stem cells derived from blood -- as a kind of donation that, under the 1984 National Organ Transplant Act, cannot be compensated. If this rule goes into effect (the public comment period ends today), anyone who pays another person for donating these cells would be subject to as much as five years in prison and a $50,000 fine.

The problem with this rule is that donating bone marrow is not like donating an essential organ. Indeed, the Ninth Circuit based its decision on the fact that modern bone-marrow procurement, a process known as apheresis, is more akin to drawing blood. In the early 1980s, when the transplant act was written, the process was more demanding, involving anesthesia and the use of large, hollow needles to extract marrow from a donors hip. But today, more than two-thirds of marrow donations are done via apheresis. Blood is taken from a donors arm, the bone-marrow stem cells are filtered out, and the blood is then returned to the donor through a needle in the other arm.

The Ninth Circuit panel held that these filtered stem cells are merely components of blood -- no different from blood-derived plasma, platelets and clotting factors, for which donor compensation is allowed.

The strongest opposition to compensation comes from the National Marrow Donor Program, the Minneapolis-based nonprofit that maintains the nations largest donor registry. Michael Boo, the programs chief strategy officer, says of reimbursement, Is that what we want people to be motivated by?

The problem with this logic is that altruism has proven insufficient to motivate enough people to give marrow and, as a result, people die.

HHS is presumably under pressure from the National Marrow Donor Program. The department does not otherwise explain its proposed rule except to claim that compensation runs afoul of the transplant acts intent to ban commodification of human stem cells and to curb opportunities for coercion and exploitation, encourage altruistic donation and decrease the likelihood of disease transmission.

But how could such concerns plausibly apply to marrow stem cells and not to blood plasma? The process of collecting plasma is safe: No serious infection has been transmitted in plasma-derived products in nearly two decades, according to the Plasma Protein Therapeutics Association. Strenuous screening and testing in a robust regulatory environment, coupled with voluntary industry standards and sophisticated manufacturing processes, have created what has been called the safest blood product available today.

Outlawing compensation for stem blood cells but not mature blood cells might even violate the constitutional guarantee of equal protection of the law, according to Jeff Rowes, a lawyer at the Institute for Justice, which represented Flynn.

HHS should withdraw its proposal. Ideally, Congress should thwart future regulatory mischief by amending the National Organ Transplant Act to stipulate that marrow stem cells are not organs.

Each year, 2,000 to 3,000 Americans in need of marrow transplants die waiting for a match. Altruism is a virtue, but clearly it is not a dependable motive for marrow donation.

---

Satel, a psychiatrist and a resident scholar at the American Enterprise Institute, is a co-author of Brainwashed: The Seductive Appeal of Mindless Neuroscience. To contact the editor responsible for this story: Mary Duenwald at mduenwald@bloomberg.net.

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The US is wrong to ban pay for bone-marrow donors - Standard-Examiner

Orlando- In a significant advance in improving the safety of donor stem cell transplants, a major clinical trial led by researchers at Dana-Farber Cancer Institute and Brigham and Womens Hospital (BWH) has shown that a novel agent can protect against the most common viral infection that patients face after transplantation.

The results represent a breakthrough in a decade-long effort to identify an effective drug for the prevention of CMV infection in transplant patients that doesnt produce side effects that negate the benefit of the drug itself, the study authors said.

The findings, from an international phase 3 clinical trial of the drug letermovir for preventing cytomegalovirus (CMV) infection in transplant patients, will be presented at the 2017 Bone Marrow Transplant Tandem Meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Orlando, Florida, February 22, 2017.

The study, which involved 565 adult patients at 67 research centers in 20 countries, compared letermovir to placebo in preventing an active CMV infection following transplant with donor stem cells. The patients, who were undergoing transplant as treatment for blood-related cancers or other disorders, all carried a CMV infection from earlier in life that had been wrestled into dormancy by their immune system. Twenty-four weeks after completing up to 14 weeks of treatment, 61 percent of the patients receiving a placebo had developed a CMV infection serious enough to require treatment or had discontinued the trial. By contrast, only 38 percent of those treated with letermovir developed that level of CMV infection or did not complete the trial.

Unlike other drugs able to forestall active CMV infection in stem cell transplant patients, letermovir did so without producing unacceptable toxicities. Most of the side effects associated with letermovir were tolerable, including mild cases of nausea or vomiting, and some swelling, investigators found. Letermovir also conferred a survival benefit: at the 24-week mark, 15 percent of the placebo patients had died, compared to 10 percent of those receiving letermovir.

For the first time, we seem to have a drug that is a true safe and effective preventive for CMV infection in stem cell transplant patients, said the studys lead author, Francisco Marty, MD, an infectious disease specialist at Dana-Farber and BWH. Letermovir will allow many patients to avoid infection, usually with no or mild side effects, and seems to provide a survival benefit in the first six months post-transplant.

Transplantation of donor hematopoietic stem cells which give rise to all types of blood cells, including white blood cells of the immune system is used to treat blood-related cancers such as leukemia, lymphoma, and myeloma, as well as several types of non-cancerous blood disorders. Patients typically receive chemotherapy to wipe out or reduce the bone marrow, where blood cells are formed, followed by an infusion of donor stem cells to rebuild their blood supply and reconstitute their immune system.

While refinements in transplant techniques have sharply improved the safety of the procedure, the reactivation of CMV infection following a transplant has been a longstanding problem.

Infection with CMV, a type of herpes virus, is one of the most common viral infections in the world. In the United States, its estimated that over 50 percent of people are infected before adulthood. In other parts of the world, infection rates can be significantly higher. The effects of CMV infection can range from no symptoms to a flu-like fever or mononucleosis (mono) syndrome. Once the immune system has brought the infection under control, the virus persists unobtrusively in the body.

The jolt of a stem cell transplant the rapid erasure or diminishment of the immune system produced by pre-transplant chemotherapy, as well as measures to prevent graft-versus-host disease can give CMV a chance to reawaken and run amok before the newly reconstituted immune system takes hold. In the early years of bone marrow transplant therapy, 60 to 70 percent of transplant recipients developed CMV infection, Marty recounts. Of those, 20 to 30 percent contracted CMV pneumonia, and of those, 80 percent died of the disease.

In previous clinical trials, several drugs aimed at preventing CMV infection in stem cell transplant patients either were not effective or produced intolerable side effects. In the absence of safe preventive drugs, physicians worked out a surveillance approach in which they provide treatment only when patients develop CMV infection, and only for a short period of time. This strategy has largely been a success: patients now have just a 2 or 3 percent chance of getting CMV disease affecting the lungs or other organs. Still, the often harsh side effects of current drugs were reason to continue the search for a useful preventive agent.

Letermovir works by a different mechanism from previously tested agents, which block an enzyme known as DNA polymerase, which viruses use to duplicate their DNA. (Human cells use the same process to replicate their own DNA.) By contrast, letermovir blocks a process by which CMV is packaged inside infected cells a wrapping that allows it to go on and infect other cells. The fact that this process does not occur in human cells may explain in part why letermovir usually gives rise to only mild side effects, researchers say.

In the trial, patients received letermovir or a placebo beginning an average of nine days after transplant. The goal was to suppress the virus before it has a chance to become active, Marty remarked. The results of this trial offer encouragement that letermovir can offer a new strategy for donor stem cell transplant patients in preventing the emergence of CMV infection following transplant.

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New antiviral drug cuts cytomegalovirus infection and improves survival in patients - ScienceBlog.com (blog)

As a devoted gran, Sipy Howard looks forward to watching her grandkids grow up.

In two years' time, the 65-year-old hopes to proudly look on as her youngest granddaughter, Sienna, goes off to school .

But devastatingly, she doesn't know if she'll be able to do so - because she urgently needs a bone marrow transplant to survive.

Sipy, a "warm and adoring" gran, was diagnosed with leukaemia on December 15 last year - which also happened to be her birthday.

Although she has been undergoing intense chemotherapy, she is in need of a bone marrow and stem cell transplant to save her life.

Now, her daughters, Emma, 34, Jolene, 32, and Sammy, 26, have launched a desperate online campaign to find a donor for her.

The heart-wrenching campaign, dubbed #SavingSipy , aims to encourage potential donors to sign up to the bone marrow register.

It stresses how simple it is to register as a donor online.

Sipy, married to husband Eli, told Mirror Online she is "moved" by the support she has received from her loved ones - as well as strangers.

"We really need as many people as possible to sign up to the register," said the mum of three, from Kenton, northwest London.

She added: "I want to see my grandchildren growing up and my youngest granddaughter going to school."

Sipy was devastated to be diagnosed with Acute Myeloid Leukemia, an aggressive blood cancer, on her 65th birthday.

Her daughters were also shocked by the diagnosis.

Emma said: "You can never prepare yourself for hearing that a loved one has cancer.

"You are suddenly filled with fear and a desperation you have never quite experienced.

"I felt like I had been hit by a car when my dad broke the news to me on my mum's birthday.

"Keeping yourself emotionally together each day becomes your only goal."

She added that her mum is currently "struggling through" her second, gruelling round of chemotherapy.

"It's the knowing that she needs us more than ever that keeps us going, keeps us fighting," she said.

"We won't give up on her and our goal of finding a match for her."

Sipy, described as "bubbly, always laughing and generally a bit nuts", is a gran to two-year-old Sienna and four-year-old Sofia.

A member of the Jewish community, she has an "open house policy" and "cares for everyone she meets", according to her family.

Her daughters are hoping that the community - specifically the Sephardi community - could help to save her life.

Sammy said: "One of the hardest things about the situation is knowing there may be someone in the world who is a match for my mum, but because they have not registered to be on the bone marrow register, they can't save her.

"This is why we are desperately trying to reach out to everyone we can and get our message across.

"We urgently need people to register now and unfortunately we don't have much time."

Jolene added: "Awareness is key."

The campaign is being supported by the charity DKMS, which aims to help blood cancer patients find matching donors.

For details of how to register as a donor online, you can visit the #SavingSipy Facebook page here or DKMS's website here .

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Adoring gran who will die without bone marrow transplant desperate to see granddaughter go to school - Mirror.co.uk

The treatment of chronic diseases and medical conditions using a patients own stem cells is an exciting, dynamic area of medicine that is enjoying unprecedented success thanks to a combination of new discoveries and impressive patient responses. Here in the US, over 600 private clinics are doing stem cell therapies, most using stem cells taken from a patients own bone marrow or fat tissue.

Unfortunately, many ailing people are reluctant or unable to undergo the harvesting of bone marrow or fat tissue. With this in mind, physician David Steenblock, president of the nonprofit Steenblock Research Institute (SRI), asked the scientists at his research institute to come up with a way of getting enough stem cells from a patients blood sample to treat their health issues.

The scientists at SRI went on to develop an FDA compliant method for winding up with as many stem cells in 2 small tubes of blood (drawn from a patient) as are normally obtained from much larger quantities of bone marrow or fat tissue. The blood is exposed to heat, cold, light and electromagnetics which yields 100 million stem cells, an amount which is ten times the minimum of 10 million cells needed to produce a clinical response.

SRIs new method has beenauthorized for use byonly one clinic: Personalized Regenerative Medicine Clinic of San Clemente, California.

Adds Dr. Steenblock, Stem Cell Therapy is experimental and thus is not covered by any insurance plan. This new method is also only available to patients of Personalized Regenerative Medicine Clinic.

Those interested in learning more are invited to call Personalized Regenerative Medicine Clinic (PRMC) at 1-949-367-8870 from 9 am to 4 pm Pacific Time, Monday through Friday. Individuals who enroll as new patients are being offered an initial office visit for free with PRMCs Dr. Donna Hanna.

About David A. Steenblock, D.O., Inc.

Dr. David Steenblock and his Personalized Regenerative Medicine Clinic are both committed to and passionate about advancing medicine. They do this, in part, by creating customized treatment regimens for patients which often includes the use of stem cells and FDA approved stem cell mobilizers and activators. In addition, Dr. Steenblock brings to the table finely honed diagnostic skills as well as a wealth of knowledge, experience, and insight plus the courage to explore, experiment and innovate in a private clinical setting.

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Steenblock Research Institute Announces New Method of Obtaining ... - PRUnderground (press release)

Science Daily

Changing the environment within bone marrow alters blood cell ... Science Daily Researchers report they can alter blood cell development through the use of biomaterials designed to mimic characteristics of the bone marrow. and more »

See the article here:
Changing the environment within bone marrow alters blood cell ... - Science Daily

The search is still on to find a matching stem cell/bone marrow donor for five month old Madalayna Ducharme. The initial search of the Canadian OneMatch Stem Cell and Marrow Network as well as Bone Marrow Donors Worldwide (BMDW) have not yet identified a matching donor for Madalayna.

Madalayna was recently diagnosd with malignant infantile osteopetrosis, a genetic disorder that prevents her bones from working properly and they become too dense. This disorder attacks vision, hearing and is life threatening.

On Friday, February 24th there is another opportunity to help Madalayna find her match. The Katelyn Bedard Bone Marrow Association will host a Get Swabbed! registration event at Holy Names High School 1400 Northwood Street from 10am to 1:30pm.

The general public is invited to join the students and staff at Holy Names High School to keep the groundswell surging in an effort to ultimately find that life saving match for Madalayna.

The age requirement to register as a Stem Cell donor is 17 to 35 years. The registrant must possess a Canadian Government issued health card.

Originally posted here:
Still Searching For A StemCell/Bone Marrow Donor For Baby Madalayna - windsoriteDOTca News

Miami Herald

Life after a heart attack: She's golfing. He's running. How they did it. Miami Herald The study in which Wilson enrolled injected millions of donor, bone-marrow stem cells into her heart. Stem cells extracted from bone marrow grow rapidly and help regulate the body to heal itself, Hare explained. After a heart attack, an area of the ...

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Life after a heart attack: She's golfing. He's running. How they did it. - Miami Herald

February 22, 2017 12:53 PM

Bryan Altman

In 2016 Angels ace Garrett Richards took to the mound just six times before being shut down for the season on May 6, 2016 due to a partial tear of his UCL (ulnar collateral ligament) in his elbow, an injury that typically requires Tommy John surgery and a prolonged absence from any baseball activities.

Fortunately for Richards his tear was a unique one as it ran lengthwise along his UCL, as opposed to a standard tear which goes across ones ligament. This, combined with new advances in stem cell technology, gave Richards the option to avoid going under the knife and instead undergo stem cell treatment.

This and much more on the topic of stem cell research and its role in baseball was revealed in a recent piece published byYahoo.coms Jeff Passan, who also went into plenty of detail regarding the nature of the actual stem cell treatment.

From Yahoo.com

A doctor guided a needle into the iliac crest of his pelvic bone and began to extract bone marrow. Richards was wide awake, the blessing of local anesthesia saving him from physical pain but not the anxiety that crept into his head: Is this really going to work?

Within a few minutes, the harvested marrow was hurried to a centrifuge, spun to separate the good stuff, mixed into a slurry of platelet-rich plasma (PRP) and readied to inject into Richards damaged right elbow.

Science, bro, Richardsreportedly told Passan. Im a believer now.

Its hard not to be if youre Richards. According to the article, if Richards opted for Tommy John surgery the earliest possible return date for him would have been following the 2017 All-Star break.

Now, Richards is poised to start the season on the hill for the Angels and has been throwing 98 MPH fastballs once again in spring training.

I feel as good as I ever have throwing a baseball, said at the teams spring training facility on Monday.

For Richards, the results have seemingly turned out stellar, and while stem cell treatment could revolutionize baseball, there is still a little bit of skepticism regarding the procedure.

From Yahoo.com

In May 2013, a paper published in the American Journal of Sports Medicine found 30 of 34 overhand throwers with partial UCL tears who used PRP had returned to their previous level of competition. This was reason for celebration. If a player could avoid the 14-month-plus recovery from the surgery, better for him as well as the team.

Another study arrived in 2016 that didnt cast doubt on the value of orthobiologics so much as offer a different avenue: rest. The 28 players used everything from electrical stimulation, ultrasound, laser therapy, massage and other soft-tissue work. And when paired with rest, their return to previous level came in at 84 percent. It was almost exactly as effective as PRP.

Even though Richards is good to go,neither him or the Angels plan on taking any chances with his arm this year.

Passan notes that Richards has used his time off to reassess his mechanics and fix any inefficiencies in his delivery, which should also help him stay healthy.

Hell be targeting a pitch count below 100 for each game and is looking to keep his workload under 200 innings, which should hopefully keep the Angels ace on the mound and off the operating/stem cell treatment table for the foreseeable future.

Read more here:
Angels' Garrett Richards Among Pitchers Using Stem Cell Treatment Over Tommy John Surgery - CBS Local

Kolkata: When 42-year-old Nilesh Kumar Sinha and 27-year-old Sajat Jain met in Kolkata on Thursday, it was a poignant moment for both of them.

While both are from Delhi, this was their first meeting.

For Nilesh, it was a moment of gratitude to Sajat for saving his life, while Sajat finally found the person whose life he had saved.

For a year and a half, Nilesh was getting stem cell transplants from Sajat who had registered through Datri, Indias largest unrelated blood stem cell registry organization.

Sajat, an entrepreneur in the healthcare sector, says his health is fine, a year and a half since the transplant took place. He says his decision to be a stem cell donor wasn't difficult. The emotion didnt come then, it came now. I had that feeling that I had saved a life but when I saw the person who has a family, it is the people around the person, and I ended up helping too. I am single and I have no dependents. Now that I know he lives in my city, why not stay in touch and interact with his family, he said.

The World Marrow Donors Association does not permit a donor and recipient to meet for a year.

Nilesh, a logistics businessman with two children, is slowly getting back to normal life. He is undergoes kidney dialysis twice a week in Kolkata after getting medicines from a US based company which are still on trial, affected his kidneys.

He is optimistic, having come this far after suffering from jaundice in March 2015 and ultimately contracting a rare blood disorder called Plastic Anemia with 40% chances of survival. It is a rare disorder where the bone marrow stops producing white blood cells, platelets and hemoglobin. He went in for stem cell transplant in November that year at Tata Medical Centre in Kolkata.

He says dialysis is nothing compared to the pain he went through after he contracted the rare blood disorder. He undertook Antithymocyte Globulin or ATG where the bone marrow of a horse is transplanted. He got better but after six months, his platelet count started decreasing. He then consulted hospitals in the US, UK and Singapore where he was told to look for an Indian stem cell donor.

That is when he came across Datri. His first donor backed out on the 2nd day of the five-day process of transferring blood stem cells. Sajat stepped in to save his life. There were some complications after the transplant, but things then started looking up. Today I am a more spiritual and knowledgeable person. I am writing about blood stem cell transplant and creating awareness on the subject. I will try and get 100 employees to register with Datri as donors from my company. Nilesh said.

East India has few donors as compared to South India with Kerala having the highest number. West Bengal has 4785 registered donors with only eight of them who have donated blood stem cells so far.

Datri is supported from Tata Medical Centre in Kolkata and the challenge now is to create more awareness in the state. Abhijit Dutt (59) became the first donor from West Bengal 5 years ago. A manager in an FMCG company, Dutt decided to register as a donor when he was contacted by Datri. Dutt has been a regular blood donor. My family supported me and the pain was minimal during the process. A Paracetemol could fix that. I went to work the next day. I help Datri and encourage other people to register as donors. He said.

Blood stem cell transplant can cure blood disorders which include Leukemia and Thalassemia. Datri was founded in 2009 with their first successful transplant being in 2011. Till date the organization has 1,80,000 registered donors and has conducted 230 successful blood stem cell transplants. The Humam Leukocyte Antigen or HLA of the recipient and donor is matched in a laboratory in the US before a transplant is considered. Co-founder and CEO of Datri, Raghu Rajagopal says, As a registry, we are immensely motivated to spread the awareness on the significance of becoming a blood stem cell donor so that many more lives can be saved. Datri is an NGO registered with Bone Marrow Donors worldwide and is a member of World Marrow Donors Association.

Read this article:
Businessman Meets 'Stranger' Who Saved His Life, Thanks to India's Largest Unrelated Blood Stem Cell Registry - News18

Researchers at the University of Illinois report they can alter blood cell development through the use of biomaterials designed to mimic characteristics of the bone marrow.

The findings, reported in the journal Science Advances, are a first step toward developing more effective bone marrow treatments for diseases like leukemia and lymphoma.

Blood cells flow throughout the body delivering life-supporting oxygen and nutrients. As these cells are used and recycled they are regenerated by bone marrow, the soft tissue inside the bodys long and hollow bones.

Certain regions of bone marrow contain hematopoietic stem cells, the precursors of all blood and immune cells, said University of Illinois chemical and biomolecular engineering professor Brendan Harley, who led the research with postdoctoral researcher Ji Sun Choi.

The tissue environment that surrounds these cells in the bone marrow provides a wealth of signals that can alter how these precursor cells behave. This paper looked at the signals provided by the tissue matrix itself, said Harley, who also is affiliated with the Carl R. Woese Institute for Genomic Biology at Illinois.

One of the major tools that oncologists use to treat leukemia and lymphoma involves transplanting HSCs. The donor stem cells must locate marrow cavities and start producing blood and immune cells. However, there is a limited quantity of available donor HSCs and the success rate of transplantation is low.

Were interested in this problem from an engineering standpoint, Harley said. The goal is to create better tools to both expand the number of donor HSCs and improve their capacity to repopulate the bone marrow after transplantation.

Like cells throughout the body, HSCs are contained in a three-dimensional tissue environment known as the extracellular matrix. Harley and Choi gathered samples of HSCs from mice and then grew them in the laboratory using biomaterials engineered to mimic some of the extracellular matrix properties of the native bone marrow. Their goal was to examine how these engineered systems could alter the HSCs capacity to proliferate and differentiate to become blood cells.

The researchers examined two main elements of the matrix that regularly interact with HSCs: collagen and fibronectin. They found that the HSCs that were exposed to collagen proliferated more rapidly but that they had differentiated, meaning they were no longer stem cells. When exposed to fibronectin, the stem cells proliferated less rapidly, but were able to maintain their stem cell-like nature.

With the collagen substrates, we got more cells but not useful cells, Harley said. With the right combination of stiffness in the matrix and the presence of fibronectin, we identified a class of biomaterials that show promise for being able to maintain and eventually expand these stem cells outside of the body. An engineered bone marrow will be of enormous value for treating hematopoietic cancers such as leukemia, but also for understanding the process of bone marrow failure and other hematopoietic diseases.

This project is only the first step in controlling the signals from the matrix that influence HSCs, Harley said. He and other researchers in his lab are currently investigating other features of the matrix that can be manipulated to increase the number of stem cells and make them more effective in transplantation.

The paper, Marrow-inspired matrix cues rapidly affect early fate decisions of hematopoietic stem and progenitor cells, is available online. The National Science Foundation, National Institutes of Health and the American Cancer Society of Illinois supported this research. _____________

Photo by L. Brian Stauffer.

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Study: Changing the environment within bone marrow alters blood cell development - ScienceBlog.com (blog)

In an interesting dispatch from spring training, Yahoos Jeff Passan reports on Los Angeles Angels pitcher Garrett Richardss recovery from a May 2016 elbow injury that shut him down for the season.

Instead of electing to undergo standard Tommy John surgery, Richards decided to try to heal his injury by getting an injection of stem cells directly into his elbow. Passan, whose 2016 book The Arm showed hes not afraid to make his readers feel queasy, described the procedure as such: Richards was fortunate to only suffer a partial tear, which is naturally easier to repair than a full tear.

A doctor guided a needle into the iliac crest of his pelvic bone and began to extract bone marrow.

[...]

Within a few minutes, the harvested marrow was hurried to a centrifuge, spun to separate the good stuff, mixed into a slurry of platelet-rich plasma and readied to inject into Richards damaged right elbow.

Gross, but it apparently worked. Passan reports Richards is feeling great and throwing 98 mph at spring training. Richards is clearly pleased with the tentatively positive outcome: Science, bro. Im a believer now, Richards told Passan.

Dr. Neal ElAttrache, sports premiere orthopedic surgeon, says he is looking forward to seeing where the research on the efficacy of orthobiologics goes, but he also has a theory that the simple resting of the muscle could be the impetus for muscle repair. Or, at least, that the two factors combined can be effective.

A stem cell procedure is less invasive than UCL surgery, of course, and right now it looks like the healing process could be much shorter than that of Tommy John surgery, at least for pitchers with partial UCL tears. Standard TJ recovery time is 14 monthsnearly long enough to inspire an oh yeah, that guy reaction when the player eventually returns. Richards underwent his stem cell procedure in May 2016 and Passan reports that he was throwing by August and was ready to go by October.

Richards will, of course, be kept on a short leash this season as he and the Angels look to avoid a setback or worse, but the potential for an expedited return from partial UCL tears is a major development for the science of pitching.

If stem cell treatments can get electric pitchers like Richards healed and back on the field quicker than surgery can, thats obviously a good thing for baseball. Still, its hard to read Passans story and not come away from it asking, Whats a PED again? Heres Richards talking about his stem cell treatment in the Los Angeles Timesback in 2016:

Stem cells are a remarkable thing. The body heals itself, so thats awesome. Were not out of the woods yet, but todays a good day.

HGH doesnt exactly work the same way this stem cell treatment appears to, but their essential benefits are the same. While the term performance enhancing drugs is still commonly associated with the mega-roids 1990s, HGH is of value to athletes largely for its ability to quicken injury recovery and extend careers. Doctors pushing orthobiologics experiments on their patients are free of the whiff of impropriety, but it seems that has less to do with their virtue than it does their good fortune at being on the right side of baseballs arbitrary PED laws.

The rest is here:
Stem Cell Treatments Could Be The Next Frontier In Fixing Broken Pitchers - Deadspin

By Sally Satel By Sally Satel February 21 at 8:04 PM

(Dr. Sally Satel, who has guest-blogged here before, was kind enough to write up this item on a topic that has long interested me; Im delighted to pass it along: -EV)

In 2007, Eugene Volokh, the host of this site, published an essay in the Harvard Law Reviewtitled Medical Self-Defense, Prohibited Experimental Therapies, and Payment for Organs in which he argued that the government should need a very good reason to prevent sick people from saving their own lives.

That insight impels the Right to Try movement, which seeks to give terminally ill patients the right to try drugs that show promise but not have received FDA approval and which has received sympathetic hearings from President Trump and Vice President Pence. One of the leaders of Right to Try reform, the libertarian Goldwater Institute, said it best: We just fundamentally do not believe that you should have to apply to the government for permission to try to save your own life.

That principle has vital implications for patients needing bone marrow and kidney transplants.

Each year, 2,000 to 3,000 individuals with leukemia and other forms of bone marrow disease die while waiting to receive another persons bone marrow cells. Its not that strangers are indifferent to their plight, but that suitable biological matches are hard to find. And even when a match is found, there is a 1-in-2 chance that the needle-in-a-haystack donor either cant be located by registry personnel or, incomprehensibly, refuses to donate even though he had earlier volunteered to be tested.

We can enlarge the pool of potential donors while increasing the likelihood that compatible donors will follow through if they are paid or if sick patients (or charities acting on their behalf) have the Right to Buy, as I call it.

But there is an obstacle to buying. The 1984 National Organ Transplant Act, or NOTA, bans exchange of valuable consideration that is, anything of material worth for solid organs, such as kidneys and livers, as well as for bone marrow.

The Institute for Justice, a libertarian public-interest law firm, fought the prohibition. It sued the Justice Department on behalf of families afraid their ill loved ones would die because they couldnt get a bone marrow transplant.

In a unanimous 2012 ruling, a three-judge panel of the U.S. Court of Appeals for the 9th Circuit rejected the federal governments argument that obtaining bone-marrow stem cells through a needle in a donors arm violates NOTA. The judges based their decision on the fact that modern bone-marrow procurement, a process known as apheresis, is akin to drawing blood. Indeed, filtered stem cells, they held, are merely components of blood, no different from blood-derived plasma, platelets and clotting factors, all of which are replenished by the body within weeks of a donation. Because its legal to compensate blood donors, its also legal to pay bone marrow donors, the court ruled.

Unfortunately, the Department of Health and Human Services rejected the courts ruling. In 2013, it proposed a rule that would extend the NOTA prohibition to bone marrow stem cells. Under the proposed regulation, anyone who accepted material gain for giving bone-marrow stem cells would be subject to NOTAs penalties, facing imprisonment for up to five years. According to HHS, compensation runs afoul of NOTAs intent to ban commodification of human stem cells and to curb opportunities for coercion and exploitation, encourage altruistic donation and decrease the likelihood of disease transmission.

The solicitor general could have asked the Supreme Court to review the 9th Circuits bone-marrow decision, but he declined. Perhaps he grasped the central folly of HHSs position: How could the agency justify its worry about opportunities for coercion and exploitation and the likelihood of disease transmission when it came to bone marrow cells, yet not apply those same concerns to plasma?

For three years, HHS has been silent on its proposed rule. Meanwhile, people are dying because nonprofits that want to begin paying donors on behalf of needy patients cant move forward until they are assured that the agency cant shut them down. The Institute for Justice is considering a legal challenge over the HHS delay, which is causing needless deaths.

But perhaps the lawsuit can wait. With a new administration that is skeptical of overregulation, HHS Secretary Tom Price could withdraw the proposed rule. Ideally, Congress would thwart future regulatory blockades by amending NOTA to stipulate that marrow stem cells are not organs covered by the act.

Changes to NOTA should also be made for other organs. I feel strongly about this on fundamental grounds of liberty but also because, in 2005, I needed to save my own life. I developed kidney failure but could not find a donor. Thank goodness, an angel, or as some readers know her, Virginia Postrel, heard about my predicament and gave me a kidney. And this summer another living saint, Kimberly Hendrickson, who saw how desperate I was many years ago, offered me one of hers when the first transplant began to fail. Every day, 12 people die because no one wasable to come to their rescue and, had a patient offered money for an organ, both the patient and the donor who accepted the money would face felony charges.

Congress could take the bold step of revising NOTA to permit donors who are willing to save the life of a stranger through kidney donation to receive valuable consideration from governments or nonprofit organizations. Or, lawmakers could take the intermediate step of creating a pilot program allowing doctors to study the effect of such measures, as proposed last May by Rep. Matthew Cartwright (D-Pa.), who introduced the Organ Donor Clarification Act of 2016.

Rather than large sums of cash, potential rewards could include a contribution to the donors retirement fund, an income tax credit or a tuition voucher, lifetime health insurance, a contribution to a charity of the donors choice, or loan forgiveness. Only the government, or a government-designated charity, would be allowed to disburse the rewards. Consequently, all patients, not just those with financial means, could benefit. The funds could potentially come from the savings from stopping dialysis, which costs roughly $80,000 a year per person.

The pilot programs, to be designed by individual medical centers, could also impose a waiting period on prospective donors, thereby cooling any impulsivity. Prospective donors would be fully informed about the risks of surgery and carefully screened for physical and emotional health, as all non-compensated kidney donors are now.

The idea of the government standing between a dying person and his salvation is deeply troubling. I know. We need to at least test better ways to recruit more marrow and kidney donors.

Dr. Sally Satelis a resident scholar at the American Enterprise Institute and editor ofWhen Altruism isnt Enough: The Case for Compensating Kidney Donors.

Read the rest here:
Right to try, right to buy, right to test - Washington Post

TEMPE, Ariz. On the day he hoped would save his elbow, Garrett Richards laid face down on a table with his back exposed. A doctor guided a needle into the iliac crest of his pelvic bone and began to extract bone marrow. Richards was wide awake, the blessing of local anesthesia saving him from physical pain but not the anxiety that crept into his head: Is this really going to work?

Within a few minutes, the harvested marrow was hurried to a centrifuge, spun to separate the good stuff, mixed into a slurry of platelet-rich plasma and readied to inject into Richards damaged right elbow. Rather than the standard tear across his ulnar collateral ligament, Richards ran lengthwise along the middle of his UCL, a rare manifestation of an increasingly commonplace injury that almost always ends with Tommy John surgery. Not in this case. While he could have chosen that route, he wanted to explore first the efficacy of the aforementioned good stuff: stem cells.

Today, Garrett Richards is darting 98-mph fastballs again. I feel as good as I ever have throwing a baseball, he said Monday from Tempe Diablo Stadium, where the Los Angeles Angels, perhaps the most Tommy John-addled team in baseball, expect to break camp with Richards as their opening day starter. The 28-year-old is the latest player to turn to orthobiologics, the class of treatments that includes stem cells and PRP, in hopes of healing an injury. While clinical studies have shown great success with those who use orthobiologics, they are not yet a panacea for the pervasive elbow injuries in baseball for two reasons: They work only on partial ligament tears, like Richards, and medical studies have yet to validate their efficacy independent of other treatments run concurrently.

The lack of knowledge as to how orthobiologics work inside the body while the proteins in stem cells and platelets are believed to regrow damaged tissue, doctors have yet to isolate best practices for particular injuries speaks to the difficulties in true medical advances. Still, the desire of Richards and others to avoid surgery lends orthobiologics enough credence to warrant further studies.

I truly think this kind of treatment has significant potential, said Dr. Neal ElAttrache, a longtime orthopedic surgeon at the Kerlan-Jobe clinic in Los Angeles who introduced orthobiologics to Major League Baseball when he injected PRP into the elbow of Dodgers reliever Takashi Saito in 2008. Theres no question biologics are here to stay and biologic manipulation is the frontier of treatment in what were doing. The problem, as I see it, is that the marketing and clinical use has far exceeded the science behind it.

Translation: Once the use of PRP and stem cells found traction in the media, pro athletes and weekend warriors alike sought their use, even if the success stories skewed anecdotal. Bartolo Colon resurrected his career after a stem cell injection in 2010 and is still pitching today at 43. Others did so without the fanfare or publicity. Richards faced a choice after being diagnosed with a partially torn UCL last May: Undergo Tommy John surgery and, at earliest, return following the 2017 All-Star break or follow the advice of Dr. Steve Yoon, a partner of ElAttraches at Kerlan-Jobe, and try to salvage the ligament with stem cells.

Science, bro, Richards said. Im a believer now.

Two weeks before Richards began his treatment, teammate Andrew Heaney had looked to avoid Tommy John via stem cells. Richards figured theyd rehab together every step of the way and be back in time for the fall instructional league. Then at the end of June, a scan showed Heaneys elbow wasnt healing, and he would need reconstructive surgery. Already Tyler Skaggs had taken nearly two years to return from his 2014 surgery, and six weeks after Heaneys, starter Nick Tropeano went down. Like Heaney, he is expected to miss the 2017 season.

It made Richards recovery that much more imperative. His first checkup, six weeks in, showed regrowth in the torn area via ultrasound. By August, he started throwing, and come October, when instructional league was in full bloom, so too was Richards. He didnt hesitate to pump his fastball and rip off one of his spin-heavy breaking balls. As far as pure, raw stuff goes, few in baseball can match Richards.

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He was convinced science was working, bro, though the skepticism about orthobiologics generally remains, and understandably so, in the medical community. In May 2013, a paper published in the American Journal of Sports Medicine found 30 of 34 overhand throwers with partial UCL tears who used PRP had returned to their previous level of competition. This was reason for celebration. If a player could avoid the 14-month-plus recovery from the surgery, better for him as well as the team.

Another study arrived in 2016 that didnt cast doubt on the value of orthobiologics so much as offer a different avenue: rest. The 28 players used everything from electrical stimulation, ultrasound, laser therapy, massage and other soft-tissue work. And when paired with rest, their return to previous level came in at 84 percent. It was almost exactly as effective as PRP.

This reinforced ElAttraches concern: Neither of those studies had a control group against which to measure, so the numbers, while impressive, could not isolate what helped and what didnt. This chicken-or-egg question struck ElAttrache just the same when Saito returned and went on to pitch five seasons.

Maybe it was the injection, ElAttrache said. Or maybe it was that we shut him down and let him heal.

Garrett Richards is darting 98-mph fastballs again after turning to orthobiologics. (Getty Images)

He doesnt know, and thats an important distinction as orthobiologics grows exponentially. In 2004, voters in California pledged to provide $3 billion for stem-cell research and create the California Institute of Regenerative Medicine. It remains a benefactor for an industry trying to find its place in the United States.

Across the world, stem cells have far greater potency. U.S. law prevents doctors from manipulating the cells in any way. They are extracted and put back into patients bodies as is. In Switzerland, for example, doctors will harvest stem cells, manipulate them to promote greater healing capacity and then inject them. At least one star pitcher this offseason sought a stem cell injection in the United States, according to sources, while another veteran traveled halfway across the world to Zurich, seeking the comparative lack of regulations just as Peyton Manning did in 2011 to help heal a neck injury that eventually needed surgery.

The future of orthobiologics domestically doesnt end with the FDA loosening rules on stem cell usage. Doctors see significant promise in stem cells from a babys umbilical cord or a mothers placenta, both of which can be frozen. Already theyre capable of harvesting stem cells from old patients and engineering the cells into an immature state. The possibilities going forward are endless.

For right now, theyre going to play themselves out in Anaheim. The danger zone for re-injury after using orthobiologics tends to fall between April and June, though Richards cant imagine falling prey again. In addition to the 13-week break from throwing he took over the summer, Richards spent 10 more weeks in the offseason letting it heal further.

During his down time, Richards studied his own delivery to find even the slightest inefficiencies. He had three numbers in mind. The first was 85. Thats the percent at which he said hell throw his fastball, though because of improved mechanics he expects it wont hinder his velocity. The second is 100. Thats the pitch limit the Angels will foist on Richards, and hes not one to fight. The third is 200. Thats the number of innings Richards wants to pitch this season. He did it in 2015 and sees no reason he cant again.

If he can throw 85 percent, keep his pitch count below 100 and get those 200 innings, it will play publicly as another validation of orthobiologics. Just the same, if Richards elbow gives out eventually, his association with stem cells could perhaps give those considering it pause. Richards pays no mind to this. He just wants to be great.

So much so, in fact, that its going to cost him. Inside the Angels clubhouse, a chart, labeled 1 through 13, is taped to the side of a locker. Its a list of shame with the price buying lunch for the entire team. Players, coaches, P.R. directors, even manager Mike Scioscia are on there. Next to No. 6, it read: G. Rich Ace. He had made the mistake of saying aloud what he believed to be true: that hes the ace of the Angels.

Fulfilling that depends on plenty of things, none as important as his elbow, and Richards knows that. Hell do everything he can to take care of it, to nurture it, to fight against its natural gift of velocity that puts him at such risk. To make sure that next time hes on a table in the doctors office, its not with his elbow opened up and another season lost.

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How baseball players are trying stem cells to avoid Tommy John - Yahoo Sports

Opinion: Oregon patients should beware of stem cell therapy fraud Portland Business Journal ... to help us understand and treat a range of diseases, injuries and other health-related conditions. For example, one long-established use of blood stem cells is to treat diseases of the blood and regrow bone marrow after certain kinds of cancer ...

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Opinion: Oregon patients should beware of stem cell therapy fraud - Portland Business Journal

The disease is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord.

It leads to problems with movement, vision, balance and speech.

The treatment, autologous hematopoietic stem cell transplantation (AHSCT), was given to patients with advanced forms of the disease who had failed to respond to other medications.

A similar approach has been trialed on people with certain forms of cancer, with encouraging early results.

Dr Paolo Muraro, the new study's lead author, said: "We previously knew this treatment reboots or resets the immune system but we didn't know how long the benefits lasted.

"In this study, which is the largest long-term follow-up study of this procedure, we've shown we can 'freeze' a patient's disease - and stop it from becoming worse, for up to five years."

The researchers noted, however, that the nature of the treatment, which involves aggressive chemotherapy, carried significant risks.

The chemotherapy deactivates the immune system for a short period of time, which can lead to greater risk of infection - of the 281 patients who received AHSCT, eight died in the 100 days after treatment.

The treatment works by destroying the immune cells responsible for attacking the nervous system.

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New stem cell treatment 'freezes' multiple sclerosis - Telegraph.co.uk

The condition is caused by the immune system malfunctioning and mistakenly attacking nerves in the brain and spinal cord

A GROUNDBREAKING treatment that resets the immune system could stop the spread of mutliple sclerosis in nearly half of patients, expertssay.

The risky treatment involves wiping the bodies immune system with cancer treatment and rebooting it with a stem cell transplant, but not all patients will be suitable.

Alamy

A stem cell transplant followed by aggressive chemotherapy could reset the immune system and manage the symptoms of MSThe treatment prevents symptoms of the disease worsening for five years in 46 per cent of patients, a study from Imperial College London found.

Multiple sclerosis affects around 100,000 people in the UK, and 2.3 million worldwide.

The condition is caused by the immune system malfunctioning and mistakenly attacking nerves in the brain and spinal cord.

This leads to a range of symptoms including fatigue, problems with arm and leg movement, vision and balance.

There is no cure but certain medications can help slow progression of the disease.

But a stem cell transplant, followed by aggressive chemotherapy, could change that.

Participants in the studyhad advanced forms of the disease and had not responded to any other treatment.

They were given aautologous hematopoietic stem cell transplantation (AHSCT) A process in which removes healthy stem cells from the body to allow medics to kill the remaining ones.

It aims to stop the immune system from attacking the bodys nerve cells.

The results, published in the journal JAMA Neurology, suggested some patients saw an improvement in their symptoms.

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In the treatment, a patient is given a drug that encourages stem cells to move from the bone marrow into the blood stream, and these cells are then removed from the body.

The patient then receives high-dose chemotherapy that kills any remaining immune cells.

The stem cells are then transfused back into their body to re-grow their immune system.

Previous studies have suggested this resets the immune system, and stops it from attacking the nerve cells.

But medics warn that because thetreatment involves aggressive chemotherapy that inactivates the immune system for a short period of time, some patients died from infections.

Out of the 281 patients who received the treatment in the study, eight died in the 100 days following the treatment.

Older patients, and those with the most severe forms of the disease, were found to have a higher risk of death.

MSis a neurological condition that affects your nerves.

Its caused when your immune system isnt working properly and the coating around your nerves, called myelin, is damaged.

The protective coating helps ensure messages travel smoothly from your nerves to your brain, but when it is damaged the messages become disrupted meaning they can slow down, become distorted or not make it at all.

Once diagnosed, MS stays with you for life, but treatments and specialists can help you to manage the condition and its symptoms.

The cause is not know and there isnt yet a cure, but research is progressing fast.

Symptoms:

Treatment: According to the MS Society, more than 100,000 people in the UK have MS and symptoms usually start in your 20s and 30s, affecting more women than men.

While there is no known cure for MS, there are several ways to treats its symptoms including medication, diet, exercise and physiotherapy.

The best course of action depends on what symptoms the sufferer has.

Dr Paolo Muraro, lead author of the study, said: We previously knew this treatment reboots or resets the immune system and that it carried risks but we didnt know how long the benefits lasted.

In this study, which is the largest long-term follow-up study of this procedure, weve shown we can freeze a patients disease and stop it from becoming worse, for up to five years.

However, we must take into account that the treatment carries a small risk of death, and this is a disease that is not immediately life-threatening.

Most patients with multiple sclerosis have a type of the disease that has flare-ups, known as relapses, followed by an improvement in symptoms.

Dr Muraro said the number of years this treatment prevented symptoms from worsening wasfar greater than would be expected in untreated patients with severe forms of relapsing MS.

Dr Muraro added: These findings are very promising but crucially we didnt have a placebo group in this study, of patients who didnt receive the treatment.

We urgently need more effective treatments for this devastating condition, and so a large randomised controlled trial of this treatment should be the next step.

Dr Sorrel Bickley, head of biomedical research at the MS Society, said: This study is one of the largest to date looking at AHSCT as a treatment for MS and the findings offer some encouraging insights.

It shows that AHSCT can slow or stop progression for many years, and the treatment is most effective in people with MS who have active inflammation in their brain and spinal cord.

There are more than 100,000 people with MS in the UK, its a challenging and unpredictable condition to live with and thats why the MS Society is funding research like this to further our knowledge and find treatments for everyone.

If anyone with MS is considering AHSCT they should speak to their neurologist as a referral is needed to access this treatment via a trial or on the NHS.

We pay for your stories! Do you have a story for The Sun Online news team? Email us attips@the-sun.co.ukor call 0207 782 4368

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Resetting the immune system 'stops MS in it's tracks for at least five years' - The Sun

February 19, 2017

Consider it one physician's giant leap for mankind. Today, the latest rocket launch from NASA's Kennedy Space Center in Cape Canaveral, Florida, included a payload of several samples of donated adult stem cells from a research laboratory at Mayo Clinic's Florida campus. The launch by SpaceX, an American aerospace manufacturer and space transport services company, is part of NASA's commercial resupply missions to the International Space Station.

The biological cells come from the laboratory of Abba Zubair, M.D., Ph.D., who says he has eagerly awaited the launch following several delays over the past couple of years. Dr. Zubair, who specializes in cellular treatments for disease and regenerative medicine, hopes to find out how the stem cells hold up in space. He says he's eager to know whether these special cells, which are derived from the body's bone marrow, can be more quickly mass-produced in microgravity and used to treat strokes. Microgravity is the condition in which people or objects appear to be weightless. The effects of microgravity can be seen when astronauts and objects float in space. Microgravity refers to the condition where gravity seems to be very small.

"At Mayo Clinic, research drives everything we do for patients," says Gianrico Farrugia, M.D., vice president, Mayo Clinic, and CEO of Mayo Clinic in Florida. "This space cargo carries important material for research that could hold the key for developing future treatments for strokea debilitating health issue. Research such as this accelerates scientific discoveries into breakthrough therapies and critical advances in patient care."

Dr. Zubair says he has dreamed of this moment all his life, with a passion for space that goes back to his childhood in the northern city of Kano, Nigeria. There, he says he came across a book about the first moon launch and became instantly enthralled. In high school, he recruited other physics students to build a model rocket prototype using corrugated metal and rudimentary materials from the local blacksmith. When it came time to apply for college, however, the school adviser steered him from becoming an astronaut. "He said it may be a long time before Nigeria sends rockets and astronauts into space, so I should consider something more practical," Dr. Zubair recalls.

With the goal of being useful to patients and helping cure disease, he headed to medical school in Nigeria. His training took him to the University of Sheffield, in Sheffield, England; the University of Pennsylvania in Philadelphia; and Harvard University in Cambridge, Massachusetts, as he specialized in bone marrow transplants and stem cell research. He came to Mayo Clinic's Florida campus to treat cancer patients and others whose conditions could be helped by regenerative medicineall the while running a research lab that studies adult stem cells.

Dr. Zubair came across a request for research proposals that involved medicine and outer space four years ago. His mother had died of stroke in 1997, and he had been thinking about stem cells as a treatment for stroke-related brain injury. Collaborating with Mayo Clinic neurologists James Meschia, M.D., and William D. Freeman, M.D., he studied mouse models of stroke.

"Stem cells are known to reduce inflammation," he explains. "We've shown that an infusion of stem cells at the site of stroke improves the inflammation and also secretes factors for the regeneration of neurons and blood vessels."

One big problem is that it may take as many as 200 million cells to treat a human being, and developing vast numbers of stem cells on Earth can take weeks.

"It's further complicated, because some patients are unable to donate cells for themselves, and, sometimes, there aren't enough donors who are a good match, as sometimes occurs for minorities," he says.

Studies in simulators on Earth have shown that adult stem cellsthe undifferentiated cells that exist in the body to replace damaged or dying cellsreproduce quickly and reliably in microgravity. While it's not known why microgravity works better than a petri dish, some researchers speculate the conditions may be similar to the floating environment of developing cells in the body. With funding from the Center for the Advancement of Science in Space, a nonprofit organization, Dr. Zubair hopes to find that, in space, stem cells can be reproduced safely in large quantities, providing new opportunities for patients.

He'll gather real-time information about the cells as astronauts conduct experiments measuring molecular changes.

"We'll be looking to see if there are genes activated in microgravity and analyzing the stages of the cell cycle," he says.

"We may discover proteins or compounds that are produced that we can synthesize on Earth to encourage stem cell growth without having to go to microgravity." Over the last three years of planning, he says he's been tickled to learn about the challenges of space-based research, such as the need for techniques to handle fluids that don't mix in microgravity.

Most importantly, experiments will continue after the expanded stem cells return to Earth.

"We'll study them to make sure they're normal, functional and safe for patients with stroke," he says. "My work in regenerative medicine has always been intentionally translationalnot just to study what the cells do and what can be done with them but to make a difference for patients. That's what makes our project unique."

For the launch, Mayo Clinic is collaborating with the Center for Applied Space Technology (CAST) in Cape Canaveral, and BioServe Space Technologies in Boulder, Colorado. CAST supported Dr. Zubair's research by providing strategic mission planning, proposal development, spaceflight technical support and served as an interface between the research team and various space activities and agencies. BioServe provided space flight hardware, on orbit research protocol and scheduling interface.

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Research from King's College London reveals a new method of repurposing existing drugs as novel treatments for depression, using laboratory studies of brain cells.

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Blast off: Stem cells from Mayo Clinic physician's lab launch into space - Medical Xpress

JACKSONVILLE, Fla. As a boy growing up in Kano, Nigeria, Dr. Abba Zubair dreamed of going to space.

On Sunday, his work hitched a ride with a private rocket blasting off from NASA's Kennedy Space Center in Cape Canaveral, Fla., on a trip to the International Space Station.

Dr. Zubair, an associate professor of laboratory medicine and pathology at the Mayo Clinic's Florida campus, prepared a science package involving stem cells as part of a resupply mission to the ISS aboard a SpaceX Falcon 9 rocket.

"It was my first rocket launch view," said Dr. Zubair, who was on hand to watch and listen to the deafening sound as his experiment rode into space. "It was incredible."

The stem cells -- specialized cells derived from bone marrow come from Dr. Zubair's lab. Dr. Zubair, according to a report from the Mayo Clinic, specializes in cellular treatments for disease and regenerative medicine. He hopes to find out how the stem cells hold up in space and if they can be more quickly produced in microgravity.

More specifically, Zubair said, he is hoping the research can help in treatment of patients who have suffered a stroke-related brain injury.

"Stem cells are known to reduce inflammation," he said in a press release. "We've shown that an infusion of stem cells at the site of stroke improves the inflammation and also secretes factors for the regeneration of neurons and blood vessels."

The problem with such a treatment and studying the treatment is generating enough stem cells for the job. Based on current regenerative medicine studies, patients need at least 100 million stem cells for an effective dose. However, reproducing stem cells can be time consuming since the cells naturally limit their numbers.

"Scalability is a big issue," Dr. Zubair said. "I've been interested in a faster way to make them divide."

And on earth, everything is impacted by gravity, from how high we grow to our bone size and other physiological traits. "So, how can we use the effect of gravity to impact how the cells divide?" he asked.

Experiments that simulate stem cell growth in microgravity, thus far, have shown cells do grow more quickly than experimental controls, he said. So he began working toward getting an experiment into space. The experiment needed to be designed so the crew onboard the space station could run the experiment with some simple training, and Dr. Zubair will be able to watch the experiment in real time via a video connection. "We'll get some data as early as next week," he said.

If all goes well, growing stem cells in space something Dr. Zubair admits sounds like a dream of the distant future might become a reality more quickly than many people think.

"There are some companies interested in floating labs," he said. "I think the future is bright. There are a lot of possibilities in the area of regenerative medicine."

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Mayo doc's stem cell experiment blasts into space - Post-Bulletin

The Times of Israel

US Kalytera buys Israel medical cannabis firm Talent for over $10m The Times of Israel Talent is currently studying the use of cannabidiol (CBD) an antioxidant extracted from the cannabis plant to prevent and treat Graft versus Host Disease (GvHD), a life-threatening condition that can occur after stem cell or bone marrow ... Kalytera Therapeutics Acquires Israeli Cannabis DrugmakerThe Jewish Press - JewishPress.com all 2 news articles »

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US Kalytera buys Israel medical cannabis firm Talent for over $10m - The Times of Israel