The U.S. company Advanced Cell Technology (ACT) and the South Korean company CHA Biotech Ltd. have announced the formation of new company that is the product of a joint venture. The new company is to be known as “Stem Cell and Regenerative Medicine International” and will be headquartered in Worcester, Massachusetts, the site of one of ACT’s laboratories and former headquarters.

CHA Biotech, which is based in Seoul, operates a cord blood bank known as CHA i-Cord in addition to an active regenerative medicine R&D facility. Similarly, ACT is well known for a number of accomplishments in regenerative medicine, especially for their development of the hemangioblast cell technology. In the new partnership, both companies will collaborate together as one new company in the further development and commercialization of proprietary stem cell technology and cell-based clinical therapies. Under the agreement, the new company will be majority owned by CHA, to whom ACT will exclusively license all of its hemangioblast technology. Hemangioblasts are precursor cells with the ability to differentiate into both hematopoietic and endothelial cell lineages, and are found in embryonic tissue as well as in the tissue and circulating stem cells in the peripheral blood of adults.

Operating the largest stem cell research institute in Korea, CHA Biotech was founded in 2000 to develop gene therapy in addition to stem cell therapies. In 2002 the company expanded into the U.S. by opening the CHA Fertility Center in Los Angeles, which was followed in 2005 by the acquisition of the Hollywood Presbyterian Medical Center, an acute-care hospital in Los Angeles.

Advanced Cell Technology is involved in both embryonic and adult stem cell research. Its Myoblast technology consists of an autologous adult stem cell therapy designated for the treatment of heart disease which has successfully completed four Phase I clinical trials and has FDA clearance to begin Phase II trials. In addition, ACT is developing its RPE (retinal pigment epithelial cell) program for the treatment of retinal degenerative disorders, and its HG (hemangioblast) cell program for the treatment of blood disorders, cardiovascular disease, stroke and cancer.

Since August of 2006, when ACT announced a novel technique for generating embryonic stem cell lines without destroying the embryos, the company has announced on several occasions the creation of human embryonic stem cell lines that did not involve the destruction of embryos. Currently ACT owns or licenses over 380 patents and patent applications, and continues to operate laboratories both in Massachusetts and California, even though it moved its headquarters from Worcester, Massachusetts to Los Angeles in 2006 in order to take advantage of the $3 billion stem cell research initiative that was voted into state law in California with the passing of Proposition 71 in 2004.

The accelerating pace of international joint ventures is merely another indication of the rapid globalization of biotechnology, especially in the field of regenerative medicine, which has the potential to change the fundamental nature of health care and medical treatment for everyone on the planet. Along those lines, ACT’s chief scientific officer and head of the joint venture, Dr. Robert Lanza, was featured in a television special with Barbara Walters entitled, “Live to be 150 – Can You Do It?”, which was broadcast in the U.S. in April of 2008.

Osiris Therapeutics announced today that it has received $5 million in payment for having reached the first production threshold of the Osteocel supply agreement with NuVasive. In a business deal that was valued at $85 million, Osiris sold Osteocel, its bone matrix product, to the San Diego-based spine specialization company NuVasive Inc. in July of 2008 for an initial payment of $35 million which is to be followed by further payments totalling an additional $50 million when milestones are reached.

According to NuVasive chairman and CEO Alex Lukianov, “Osteocel provides what we believe to be one of the more powerful biologic platforms on the market today.” Osiris CFO Richard Hunt adds, “It is through the hard work and dedication of our Osteocel team that we have achieved the first product supply milestone under the agreement and are solidly on track to hit the remaining milestones. With more than 15 years of rigorous stem cell research and development behind it, today Osteocel stands alone in orthopedics. Along with our excellent partners at NuVasive, we look forward to the product’s continued success.”

A leader in adult stem cell therapies, Osiris Therapeutics is focused on the development of products for the treatment of inflammatory, orthopedic and cardiovascular diseases. One of its proprietary adult stem cell products, Prochymal, is currently in Phase III clinical trials for the treatment of Graft-versus-host disease and Crohn’s disease, and is also being evaluated for the repair of heart attack damage, the protection of pancreatic beta islet cells in patients with type 1 diabetes, and for the treatment of chronic obstructive pulmonary disease. Another product, Chondrogen, is currently undergoing evaluation for the treatment of arthritis in the knee. With an extensive intellectual property portfolio containing 47 patents, Osiris has formed a partnership with Genzyme Corp. for the development and commercialization of Prochymal and Chondrogen in countries outside of the U.S. and Canada.

In a series of experiments that are founded upon the success of Genzyme’s proprietary drug, Mozobil (see “Genzyme Receives FDA Approval for Mozobil”, December 15, 2008), scientists at the Imperial College of London have demonstrated the unsuspected regenerative potency of endogenous, autologous adult stem cells.

A novel, proprietary small-molecule CXCR4 chemokine receptor agonist, Mozobil is designed for use with G-CSF (granulocyte-colony stimulating factor) and has already received FDA marketing approval in the treatment of non-Hodgkin’s lymphoma and multiple myeloma. By stimulating the migration of hematopoietic stem cells from the bone marrow into the bloodstream for subsequent collection and autologous stem cell transplantation, Mozobil has already been shown to play an important role in the treatment of plasma and hematologic cancers. Now, however, researchers at the Imperial College of London have demonstrated for the first time that the regenerative power of autologous adult stem cells is not limited only to blood cells but also extends to the regeneration of other tissue, such as bone and blood vessels.

According to Dr. Sara Rankin, who led the study at the Imperial College of London, “It’s promoting self-healing. We’re simply boosting what’s going on naturally.”

The experiments were conducted with a mouse model in which Dr. Rankin and her colleagues selectively administered Mozobil in combination with either of the natural growth factors G-CSF or VEGF (vascular endothelial growth factor). When combined with VEGF, Mozobil was found to stimulate mesenchymal stem cells (MSCs) which differentiate into bone and other tissue types, as well as endothelial progenitor cells which differentiate into blood vessels. By contrast, G-CSF, which is known to stimulate the mobilization of hematopoietic stem cells, was found not to stimulate the production of MSCs. Similarly, VEGF was found not to stimulate hematopoietic stem cell mobilization. The degree to which stem cell mobilization increased was particularly dramatic, as mice that received VEGF in combination with Mozobil were found to release approximately 100 times as many endothelial and mesenchymal stem cells into the bloodsteram when compared to control mice who did not receive the treatment.

This is the first concrete evidence that different mechanisms of stimulation release different, specific types of stem cells. As Dr. Robert Lanza, chief scientist at Advanced Cell Technology in Worcestor, Massachusetts, explains, “The ability to selectively stimulate a patient’s own stem cells could be a powerful tool for treating disease, and in speeding up the repair of damaged and worn-out tissues.”

Genzyme, the manufacturer of Mozobil, received marketing approval last month from the FDA for the use of Mozobil in combination with G-CSF for the mobilization of hematopoietic stem cells in the treatment of non-Hodgkin’s lymphoma and multiple myeloma. According to John DiPersio, M.D., Ph.D., a professor at Washington University in St. Louis, “This product should become an integral part of the treatment regimen for transplantation because of the benefits it offers to patients, physicians and transplant centers.”

Professor Peter Weissberg, Medical Director at the British Heart Foundation, agrees. “It has long been known that the bone marrow contains cells that can replace lost or aged blood cells,” he explains. “It now seems increasingly likely that the bone marrow also contains cells that have the capacity to repair damaged internal organs, such as the heart and blood vessels, but that too few of them are released to be effective. This research has identified some important molecular pathways involved in mobilizing these cells. It may be possible to develop a drug that interacts with these pathways to encourage the right number and type of stem cells to enter the circulation and repair damage to the heart.”

Dr. Sara Rankin adds, “The body repairs itself all the time. However, when the damage is severe, there are limits to what it can do of its own accord. We hope that by releasing extra stem cells, as we were able to do in mice in our study, we could potentially call up extra numbers of whichever stem cells the body needs, in order to boost its ability to mend itself and accelerate the repair process. Mozobil is already out there on the market, so it’s feasible that trials could happen in the next five to ten years.”

Osiris Therapeutics, one of the leading biotech companies to develop clinical therapies from adult stem cells, announced today that it has completed patient enrollment in its phase III trial for the evaluation of Prochymal in the treatment of steroid-refractory acute Graft versus Host Disease (GvHD), which is a potentially fatal complication from bone marrow transplantation. Prochymal, one of the proprietary adult stem cell therapies developed by Osiris, is formulated exclusively from mesenchymal stem cells (MSCs), which are well known for their ability to prevent inflammation and scarring in addition to their capacity to regenerate tissue. A number of studies have already demonstrated MSCs to be effective in the treatment of GvHD, such as one study recently published in the Lancet in which Le Blanc et al. reported a 55% complete response rate from MSCs that were used in the treatment of steroid-resistant GvHD. Other studies have demonstrated a 58% complete response rate in pediatric patiens with end-stage GvHD, and phase II trials evaluating Prochymal have demonstrated a 77% complete resolution rate.

A total of 244 patients are now enrolled in the phase III trial, which is designed to assess both safety and efficacy of Prochymal over a 6-month period in a double-blinded, placebo controlled study that is coordinated among 72 leading bone marrow transplant centers across the United States, Canada, the United Kingdom, Spain, Italy, Germany, Switzerland and Australia. Among other places, these 72 medical centers in the U.S. include the Fred Hutchinson Cancer Research Center in Seattle, Washington, the M.D. Anderson Cancer Center in Houston, Texas, and the Karmanos Cancer Institute in Detroit, Michigan.

According to Dr. Paul Martin of the Fred Hutchinson Cancer Research Center, professor at the University of Washington and a lead investigator in the trial, “Completion of this study’s enrollment represents an outstanding accomplishment for the transplantation field. Steroid-refractory acute Graft versus Host disease poses one of the most serious and difficult to treat complications that can occur after bone marrow transplantation. Previous studies have not identified reliably effective treatments, and no drugs have been approved for this devastating disease. Transplant clinicians throughout the world now eagerly await results of this rigorous multicenter study.”

Thus far, 168 patients have been treated in the United States, 31 in Canada, 27 in Europe and 18 in Australia, which included a total of 27 pediatric patients. The last patient is expected to complete the trial in May of 2009.

As Dr. Moya Daniels, director for the GvHD program at Osiris, states, “On behalf of everyone at Osiris, I would like to offer our sincere appreciation to the patients, their families, and all of the outstanding healthcare professionals who participated in this historic event. We look forward with great anticipation to the results of this landmark stem cell trial and the opportunity to make a positive difference in the care of transplant patients everywhere.”

Prochymal has often been in the news lately, since Osiris and Genzyme announced a strategic alliance in November of this year for the development and commercialization of Prochymal. In the current phase III trial, which is evaluating Prochymal in patients who have failed to respond to corticosteroid treatment for acute GvHD, the key endpoints of this trial are complete response, as well as both 100-day and 180-day survival.

Osiris is also currently investigating Prochymal as a first-line agent for acute GvHD in a 184-patient phase III trial and as a therapy for Crohn’s disease in a 270-patient phase III trial. Prochymal is the only stem cell therapy currently designated by the FDA as both an Orphan Drug and a Fast Track product, and it is also being developed for the repair of heart tissue following a heart attack, and for the protection of pancreatic islet cells in patients with type 1 diabetes, and for the repair of lung tissue in patients with chronic obstructive pulmonary disease. Other adult stem cell therapies developed by Osiris and currently in their pipeline include Chondrogen which is being developed for a number of applications that include arthritis of the knee. The recent partnership between Osiris and Genzyme is geared for the development and commercialization of both Prochymal and Chondrogen in countries outside of the United States and Canada. In their intellectual property portfolio, Osiris has 47 U.S. patents, each with one or more foreign counterparts.

As in any industry, an unmet need and the potential for economic gain often combine to produce two opposite results: on the one hand, such opportunity will attract legitimate experts who are authentically qualified to provide a beneficial service or product that meets a need, and, on the other hand, charlatans whose illigitimate services or products have no validity whatsoever will also be attracted to the field. Such has always been the case in most, if not all, economic sectors throughout history, especially in medical specializations, and such will probably always be the case throughout the future, given human nature and the tendency of history to repeat itself. Whether dealing with cars, jewelry or designer clothing, low quality reproductions of the most coveted styles abound and are often deliberately promoted as being something which they are not. It should come as no surprise, therefore, that the stem cell industry is no different. Fortunately, however, there is a simple “antidote” to such a danger: knowledge.

Since ancient times, free market economics have warned the buyer to beware, and fraudulent market activity is hardly a modern phenomenon. The very same market forces which allow for the possibility of deception on the part of the seller, however, also demand, and motivate, some level of intelligence and education on the part of the buyer. Predictably, therefore, deceptive products and services will often arise wherever legitimate opportunity and progress also exist, and history has repeatedly proven that this is usually not a question of “if” but rather a question of “when”. In a population of educated and well-informed consumers, however, such deception will be shortlived, as knowledgeable people will be able to tell the difference between something of quality and value, as opposed to something that is worthless and perhaps even dangerous.

Unlike with cars, jewelry or designer clothing, the consumers of stem cell therapies are often patients with life-threatening disease or illness who are desperate for any treatment whatsoever. Consequently, scientists and governments alike are working to formulate official guidelines and regulatory laws that will protect the patient by ensuring, as much as is humanly possible, the legimacy of stem cell providers, and also by penalizing those who violate such regulation. Meanwhile, however, the stem cell field is still in its infancy, and the basic premises behind such regulation are not yet globally respected. Consequently, at the moment, anyone who wishes to peddle modern versions of snake oil while masquerading as a stem cell expert is free to do so, and those who actually do engage in such unethical and medically dangerous activity are tireless in their efforts to profit from the exploitation of consumers, especially with the ease of marketing their products and services over the internet.

According to Dr. Insoo Hyun, associate professor of bioethics at Case Western Reserve University School of Medicine in Cleveland, Ohio, and the lead author of a paper outlining the commercial guidelines of stem cell therapies, “Stem cell research is progressing so rapidly and has sparked a lot of interest in translational research including among patients in hope for therapies. At the same time, legitimate science is speeding ahead and getting to the point where there needs to be more of a roadmap to take the basic knowledge to clinical applications.” Although such incidents have not yet made major news headlines, Dr. Hyun adds that it is “only a matter of time” before someone somewhere is physically harmed by bogus stem cell therapies.

According to Dr. Paul Sanberg, professor of neurosurgery and director of the University of South Florida Center for Aging and Brain Repair in Tampa, “We clearly need guidelines for around the world to make sure that appropriate research is done before clinical work is undertaken in patients. We see desperate patients all the time and want to make sure that any therapies they take come from responsible research groups.” Similarly, Dr. Darwin Prockop, chair of Genomic Medicine and director of the Texas A&M Health Science Center College of Medicine Institute for Regenerative Medicine, adds, “There is tremendous confusion about the two types of stem cells, embryonic stem cells and adult progenitor stem cells. The difference is monumental, and needs to be clarified.”

Although there do exist a number of clinics around the world which actually offer legitimate, scientifically based adult stem cell therapies, there also exist a number of clinics which do not offer anything of legitimacy, even though they purport to be legitimate. Accompanying the recent publication of stem cell guidelines is a commentary by Canadian researchers which contains an analysis of 19 websites that were found from a simple Google search, all of which advertize expensive stem cell therapies of dubious validity and safety. For example, a number of clinics in a number of countries such as China and the Ukraine claim to have treated thousands of patients for everything from Parkinson’s disease and stroke to heart conditions, but without any scientific verification or corroboration of their claims. Indeed, a team of scientists from the University of Alberta were unable to find any substantiating evidence for any of the claims made by such clinics, nor were they even able to find any verification that real stem cells were actually used in the treatments, nor what types of stem cells might have been used, nor what the source of the cells might have been (human or nonhuman, for example, adult or fetal or embryonic, etc.). Additionally, nowhere were risks or contraindications mentioned on any of the websites for any of the clinics. Given the typical cost of such therapies, which averaged around $21,500, one might assume that prospective “customers” would be interested in obtaining prior verification of the safety and efficacy of such procedures, but apparently many patients who would otherwise have no treatment whatsoever are willing to take extraordinary risks, financially as well as medically, in exchange for even a false glimmer of hope, since even false hope is better than nothing, from the perspective of someone whose very life is already at risk.

According to Dr. Hyun, the newly formulated guidelines are meant to illuminate stem cell research and to guide researchers toward responsible and accountable practices, rather than to hinder or discourage their progress. Indeed, agencies such as the U.S. FDA (Food and Drug Administration) typically perform such roles, though not all countries have such regulatory governmental agencies. Furthermore, even in countries such as the U.S., where a powerful FDA has been governing medical research and clinical practices for years, specifically for the protection of human patients who are being treated with clinical therapies, nevertheless there is still the problem that such guidelines are outdated and do not apply to the stem cell field. The stem cell field is still young enough, and so radically different from all previous specializations of medical science, that the issues which are unique to stem cells have never before been fully addressed. As Dr. Hyun explains, “Most of the time, stem cell products are presenting entirely novel products that are unpredictable in humans. Unlike drugs, you can’t just create a batch and put them on the shelf and expect they will be the same. We need uniform quality control and manufacturing. And if they’re embryonic or pluripotent stem cells, they could form unwanted tissues or tumors. So, we have to be very careful about following up and monitoring patients.”

Authored by a task force composed of stem cell specialists from 13 countries, the new guidelines address, among other topics, questions of ethical review, quality and safety, voluntary informed consent of participants in research projects, careful monitoring of volunteers, and caution in using stem cell therapies outside of a research context. Hopefully, the ethical principles which are at the very essence of such guidelines will be given serious attention and consideration by stem cell researchers throughout all countries of the world.

For those patients who are still awaiting stem cell cures for their diseases and illnesses, the field seems to be advancing much too slowly. As Dr. Hyun points out, however, not all progress is visible to the public. “For patients, it’s not surprising that there are not direct applications,” Dr. Hyun adds, “but what is often lost to the public is that so much knowledge has been gained from stem cell research. The advancements for patients are going to come sooner through these indirect routes, not direct cell-based therapy, but from the expansion of knowledge.”

In addition to the need for ethical guidelines, there is another lesson to be learned from the increasing number of bogus stem cell therapies that are springing up around the world. Namely, the necessity and urgency of such guidelines also highlights the necessity and urgency for formal, official government approval of those adult stem cell therapies which have already been proven to be safe and efficacious, so that more clinics that offer such therapies will be allowed to open in their native countries, such as the United States, instead of having to locate themselves overseas in foreign countries where they are competing against the clinics that offer bogus therapies. In other words, an updated revision of the FDA approval process, so that it is directly relevant to stem cell therapies, would allow more adult stem cell therapies to be available throughout the U.S. to more patients with various diseases and injuries, who could benefit from such therapies but for whom such therapies have not yet received FDA approval. The current FDA approval process, which was designed years ago with the specific goal of testing safety and efficacy in pharmaceutical drugs, is in many ways neither relevant nor logical when applied to the testing of stem cell therapies. Such a topic is highly complex and could constitute an entirely separate publication unto itself. Suffice it to say that a swifter, more precise and more modernized FDA approval process which is specifically tailored to stem cell therapies is desperately and urgently needed in the United States, as is its equivalent in other countries.

Meanwhile, however, as in any market, consumers must arm themselves with the power of knowledge, which is their greatest defense. Especially where the quality of a product or service can make the difference between life and death, such as with stem cell therapies, it is all the more critically important that the buyer beware.

A novel population of adult stem cells has been found to repair damaged heart muscle in an animal model, and the results suggest a wide range of therapeutic applications for human diseases and injuries. Led by Dr. John Huard, scientists at the Children’s Hospital in Pittsburgh, Pennsylvania have used myoendothelial cells, derived from skeletal tissue, to treat heart damage in mice which was similar to the damage found in humans following a heart attack.

The myoendothelial cells had been purified from human skeletal tissue, and were found not only to repair the injured heart muscle but also to stimulate angiogenesis (the growth of new blood vessels) within the heart, and the cells were also shown to reduce the formation of scar tissue following the injury, all of which dramatically improved left ventricle function. The formation of cardiac scar tissue following a heart attack is a common and serious problem and is often the cause of a second heart attack in many patients. Dr. Huard and his colleagues have now demonstrated that this particular population of adult stem cells, myoendothelial cells, adequately correct all types of damage to the cardiac tissue caused by heart attacks. In fact, at 6 weeks after injection, the myoendothelial cells were found to be 40 to 50% more effective in repairing heart muscle than were previous approaches which employed only myoblasts (muscle cells).

According to Dr. Huard, “This study confirms our belief that this novel population of stem cells discovered in our laboratory holds tremendous promise for the future of regenerative medicine. Specifically, myoendothelial cells show potential as a therapy for people who have suffered a myocardial infarction. The important benefit of our approach is that as a therapy, it would be an autologous transplant. This means that for a patient who suffers a heart attack, we would take a muscle biopsy from his or her muscle, isolate and purify the myoendothelial cells, and re-inject them into the injured heart muscle, thereby avoiding any risk of rejection by introducing foreign cells.”

Myoendothelial cells have previously been used as a therapy for numerous conditions, most recently in the repair of bladder muscle in women. Many diseases and injuries involve damaged muscle, of many varieties, and can therefore be alleviated with a treatment that not only regenerates muscle cells but which also stimulates angiogenesis and blocks the formation of scar tissue. Consequently, numerous therapeutic uses are expected for this population of myoendothelial cells, one of which includes the treatment of Duchenne muscular dystrophy (DMD), a genetic disease that strikes approximately one in every 3,500 boys and which is caused by a lack of the protein dystrophin, which gives muscle cells their structure.

As the Director of the Stem Cell Research Center at Children’s Hospital and professor and vice chair for research in the Department of Orthopedic Surgery at the University of Pittsburgh School of Medicine, Dr. Huard will begin clinical trials on humans next month.

Physicians announce their successful results for the first patient to be treated with autologous adult stem cells in a clinical study of pulmonary hypertension.

Led by Dr. Leonel Fernandez Liriano, professor of medicine at the Pontifical Catholic University School of Medicine in the Dominican Republic, the international medical team announced their 9-month follow-up results for the clinical trial, in which autologous (in which the donor and recipient are the same person) adult stem cells were extracted from each patients’ own blood and differentiated into new blood vessels.

According to Dr. Zannos Grekos, assistant clinical professor of cardiology at Nova Southeastern University and a member of the international team that developed the stem cell treatment protocol, “It goes against traditional theory that we should try to fix the existing pulmonary vasculature, but we are generating new blood vessels with impressive results.”

The clinical study represents a collaborative effort involving researchers from the Tel Aviv based company TheraVitae, and physicians from the Florida based adult stem cell company Regenocyte Therapeutic, which also includes physicians from Regenocyte’s Dominican Republic division. Patient baseline and follow-up testing are being conducted in part by the Mayo Clinic.

Karl Wagner, the 46-year-old patient who was the first to be treated, was previously described as having been in a rapid decline prior to receiving the adult stem cell therapy in February of 2008. According to Mr. Wagner, after having first been diagnosed with pulmonary hypertension, “I was being managed by medication but still had violent chest pains, heart palpitations, extreme fatigue, and severe shortness of breath. I could barely do anything with my daughters and was on oxygen almost all the time. Doctors at the Mayo Clinic gave me a three year prognosis.”

After being treated with the adult stem cell therapy, Mr. Wagner’s pulmonary artery pressure improved from 41 mm Hg, which is classified as severe pulmonary hypertension, to 24 mm Hg, which is classified as normal. The other patients who participated in the clinical trial are showing the same pattern of improvement.

According to Dr. Hector Jose Rosario, professor of cardiology and director of cardiovascular therapy for Regenocyte’s Dominican division, “This is the first time medical science has successfully reversed the disease process in pulmonary hypertension, a previously untreatable condition with a very grim prognosis.” As Dr. Grekos adds, “Using advanced engineered stem cell technology and innovative delivery methods, we’ve been able to harness the regenerative power of stem cells and literally replace the damaged blood vessels in the lungs of the pulmonary hypertension patients.”

According to Mr. Wagner, whose oxygen saturation levels are now consistently high, so that he no longer needs to be supplemented with oxygen nor is he a candidate for a lung transplant any longer, “I feel great and have a normal life again. I take my girls to school every morning and work all day. My quality of life is ten-fold what it used to be. I also am off almost all of my medications and the doctors at Mayo Clinic have given me a new prognosis.”

The autologous adult stem cell therapy used in the study is based upon several years of Regenocyte’s clinical experience in the treatment of cardiac and vascular disease. As Dr. Athina Kyritsis, chair of Regenocyte’s Scientific Advisory Board, explains, “In treating diseases like cardiomyopathy and peripheral vascular disease, we’ve had consistent success in generating viable heart tissue and growing new vessels. With the increased circulation, healing of wounds, and improvement in ejection fractions, it seemed a natural progression to approach pulmonary hypertension in the same manner. I believe we have only begun to discover what adult stem cells can accomplish in altering the course of diseases now thought to be untreatable.”

The clinical trial was conducted with support from the nonprofit Alliance for the Advancement of Adult Stem Cell Therapy and Research.