Adult Stem Cells Treat Cerebral Palsy

Europe’s leading stem cell organization, the XCell-Center of Germany, has released results from a follow-up study in which significant improvement was seen in 67% of 45 cerebral palsy patients who were treated with their own autologous adult stem cells derived from bone marrow.

According to the press release, the most common improvement reported by the patients was improved hand and finger coordination, as well as less upper limb spasticity. Additionally, improvement in leg and foot coordination were observed in nearly half of the patients, with 40% reporting reduced lower limb spasticity, and 20% reporting improvement in walking ability. Speech improvement was also found in 40% of the patients, and 20% reported improved cognition.

As described by Mrs. Ritu Giacobbe, whose 13-year-old son was among the patients treated in the study, "Not long after the treatment, our son started speaking in full sentences. His fine motor skills have improved and he can now hold his fork and eat without help."

Other parents of children who were recently treated at the XCell-Center had nothing but praise for the therapy. According to the mother of a boy who was treated, "For Dominic, the most significant improvement has been his ability to focus his eyes." Similarly, according to the mother of another boy who received the therapy, "Some of the milestones are significant. Harrison can roll himself over now. He holds his head up without his chin sinking into his chest. His speech is clearer."

According to Dr. Ute Tamaschke, pediatric neurosurgeon at the XCell-Center, "These results confirm what we see in Germany on a weekly basis: that treating patients with their own stem cells yields positive results. Many of these children require less care and are now more independent. And this positively impacts the quality of life of the children and their caregivers. We couldn’t be more delighted."

The treatment involves harvesting a small amount of bone marrow from the patient’s hip via a procedure known as thin needle mini-puncture, from which the adult stem cells are then separated, counted, purified and readministered into the patient’s cerebrospinal fluid via a fine spinal needle between the L4 and L5 vertebrae. From the cerebrospinal fluid, the stem cells are automatically transported into the brain where they naturally target and regenerate damaged tissue.

The cost for the treatment for cerebral palsy patients starts at around 9,000 Euros.

With clinical treatment centers in both Cologne and Dusseldorf, Germany, the XCell-Center is the first privately-owned clinic in Europe to specialize in regenerative medicine using autologous adult bone marrow stem cell therapy. Since its founding in January of 2007, the XCell-Center has treated more than 1,600 patients – "safely", as stated on the website.

The XCell-Center uses therapies that are based exclusively upon autologous (in which the donor and recipient are the same person) adult stem cells derived from bone marrow. In no case are embryonic stem cells ever used. As stated clearly on their website, "Therapy with embryonic stem cells is strictly prohibited in Germany. At the XCell-Center, we only use the patient’s own stem cells for therapy."

Stem Cell Awareness Day Events Planned in California

Events throughout California are planned in honor of Stem Cell Awareness Day today, with particularly notable activity scheduled at UC-Merced.

Among other events, short primer courses on stem cells will be offered by a number of professors at the University who include Drs. Marcos Garcia-Ojeda, Nestor Oviedo and Maria Pallavicini, all of whom will describe the basics of stem cells and how even organisms such as worms can lend insight into stem cell biology.

Members of the Stem Cell Consortium – a research group consisting of faculty, graduate students and post-doctoral fellows – will also present updates on the construction of the newly planned Stem Cell Instrumentation Foundry, to be located in the Science and Engineering Building at UC-Merced. As of August of this year, the California Institue for Regenerative Medicine (CIRM) has awarded $8.49 million to UC-Merced for stem cell research, which includes $4.3 million for construction of the Foundry.

According to Dr. Pallavicini, dean of the School of Natural Sciences, "This work is the foundation for groundbreaking treatments and cures for debilitating conditions such as cancer, multiple sclerosis, heart disease and spinal cord injuries."

The tenth and newest campus in the University of California system, UC-Merced is also the first U.S. research university to have been built in the 21st century, with its inaugural opening in September of 2005.

Stem Cell Awareness Day was originally proposed jointly by Governors Arnold Schwartzenegger of California and Jim Doyle of Wisconsin. Other events are taking place today throughout California, including presentations at Santa Clara University, known as "the Jesuit University in Silicon Valley", where a particular emphasis on the ethical issues of stem cell research are being highlighted.

Adult Stem Cells Used in Clinical Trial for Heart Failure

The Florida-based company Bioheart announced today results from Part 1 of its FDA-approved Phase II/III clinical trial in which its proprietary adult stem cell product is being tested in the treatment of congestive heart failure (CHF). Known as the "MARVEL Clinical Program", the trial is designed to assess cardiac function and quality of life in patients with CHF after they are treated with their own adult stem cells. Specifically, the study utilizes a proprietary therapeutic product known as MyoCell, which is developed from autologous skeletal myoblasts (ASMs) derived from each patient’s own leg muscles. After patient biopsies were shipped to Bioheart laboratories, the ASMs were isolated, purified, expanded and returned to the physician for injection back into the patient. During a six-month observation period, the patients who were treated with their own ASMs were found to have increased their walking distance by 91 meters during a six-minute period of exercise, whereas those patients in the control group who were treated only with a placebo were found to have decreased their walking distance by 4 meters. As stated in Bioheart’s official press release, "This may suggest that patients with heart failure could return to a more active lifestyle after receiving Bioheart’s treatment."

Although this was a small pilot study, with an enrollment of 20 patients from whom 3 and 6 month follow-up data were obtained, it was an important step in the lengthy and expensive process of obtaining FDA marketing approval. Now that the product has met safety requirements, it will move on to Part 2 of the Phase II/III clinical trials, just as soon as the company achieves additional funding.

Thomas Povsic, M.D., Ph.D., principal investigator of the study and assistant professor at the Duke University Clinical Research Institute, which coordinated the clinical trial, presented the efficacy data from Part 1 of the MARVEL study at a meeting of the Heart Failure Society of America in Boston. Also participating in the presentation were Dr. Chris O’Connor, head of the heart failure department at Duke University, and Dr. Warren Sherman, director of Stem Cell Research and Regenerative Medicine at the Center for Interventional Vascular Therapy at Columbia University Medical Center.

According to Dr. Sherman, "For years it has been very clear that certain patients with CHF derive considerable benefit from myoblast implantation. However, our clinical impressions have not been substantiated, and won’t be until we have data available from a large, Phase II/III randomized, controlled study, powered to detect the effects of these cells on meaningful clinical endpoints. Part 2 of MARVEL will help answer this question and become a benchmark study. The field is replete with ‘next steps’ and other studies are waiting in the wings for the ice to be broken. MARVEL will do that."

As Karl Groth, Ph.D., president and CEO of Bioheart, adds, "The Part 1 results of the MARVEL trial show positive signs during treatment and an improvement in chronic heart failure patient’s ability to walk distances and be active. This means that a patient may well return to a more active lifestyle. We are committed to moving this study forward and to seeing our technology impact on the population affected by chronic heart failure."

As Dr. Povsic further added, "We are pleased to be able to present this data to our heart failure colleagues. The MARVEL-1 trial was the first truly blinded study of intramyocardial stem cell delivery via a percutaneous approach. The results have immense implications for the design of MARVEL-2 as well as other similar trials. The improvements we observed in the 6-minute walk are clinically meaningful, and this is the first time improvements have been demonstrated in relation to a blinded placebo control group. MARVEL-1 is a pilot study, but the findings are encouraging and suggest that additional trials are warranted."

The American Heart Association estimates that there are over 5 million people suffering with CHF in the U.S. alone, with direct and indirect costs exceeding $30 billion per year. An additional 500,000 patients are diagnosed with CHF in the U.S. each year. Since conventional medicine currently offers no known cure for CHF, an autologous adult stem cell therapy would be able to fill an ever-increasing and unmet need.

As described on their website, "Bioheart is a biotechnology company focused on the delivery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic, acute heart damage, and peripheral vascular disease." The company develops its proprietary therapeutic products exclusively from autologous adult stem cells. In no case are embryonic stem cells ever used, since embryonic stem cells pose a number of technical problems and medical dangers, not the least of which is the formation of teratomas (tumors). By sharp contrast, adult stem cells do not pose any such dangers, and of all the various types of adult stem cells, autologous (in which the donor and recipient are the same person) adult stem cells are among the most easily attainable, with no risk of immune rejection and therefore no need for dangerous immunosuppressive drugs.

As further described on Bioheart’s website, the company’s lead product, MyoCell, "is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients." In addition to MyoCell, other products in Bioheart’s pipeline include multiple candidates based upon autologous, adipose-derived adult stem cells, and MyoCell SDF-1, a therapy developed from autologous adult stem cells that are genetically modified to express additional growth proteins of potential therapeutic value.

Shares of Bioheart rose 22%, or 42 cents, at the news of the clinical trial data, closing today at $2.30.

Stem Cell Pioneers Honored at Lasker Awards

This year’s Lasker Awards were presented to 6 individuals, two of whom are pioneers in the field of stem cell technology.

Dr. Shinya Yamanaka of Kyoto University in Japan, the first person to develop iPS (induced pluripotent stem) cell technology, received the prestigious award as did Dr. John Gurdon of Cambridge University in England, who pioneered the SCNT (somatic cell nuclear transfer) laboratory procedure. Among the remaining 4 recipients were 3 scientists who led the development of the cancer drug Gleevec, sold by Novartis of Switzerland, and New York City Mayor Michael Bloomberg.

According to Maria Freire, president of the Albert and Mary Lasker Foundation, and in specific reference to Drs. Gurdon and Yamanaka, "These two pieces of research allow us to understand different aspects of stem cells. I think it could lead to personalized replacement therapy to fix cells or damaged tissue."

Dr. Gurdon was the first person, in the late 1950s, to develop the technique that is now known as somatic cell nuclear transfer (SCNT). Taking cells from the gut of a frog, he inserted the nucleus of one cell into a denucleated egg, thereby creating a tadpole with the same genotype of the original frog. Ian Wilmut’s cloning of Dolly the Sheep in 1996 was directly based upon such work, as was Dr. Yamanaka’s achievements with iPS cells a decade later. Both Drs. Gurdon and Yamanaka share the Lasker Award category for basic medical research.

As is not uncommon with pioneering medical and scientific advances, both Drs. Gurdon and Yamanaka overturned conventional wisdom. As Dr. Gurdon, now 76, describes, "The prevailing thought was that as cells differentiate, they lose their ability to generate other cells of any kind." His research demonstrated that such dogma was clearly incorrect.

More recently, Dr. Yamanaka achieved a similar accomplishment as Dr. Gurdon did, but without the use of an egg, on which Dr. Gurdon commented, "We did it by transferring the nucleus of a cell. Amazingly, he does it by adding genes to the cells and some of them go back to being embryo cells." After his accomplishment in the 1950s, Dr. Gurdon thought that it would eventually be possible to clone entire animals, although he adds, "but I did not expect it would be possible to do what Yamanaka did." Now, the procedure that Dr. Yamanaka pioneered has been repeated in stem cell laboratories throughout the world, and is also being used by a number of pharmaceutical companies in drug development. As Dr. Yamanaka describes, "Everyone can do it. You don’t have to have human embryos and you can make stem cells directly from patients." In addition to directing the Center for Induced Pluripotent Stem (IPS) Cell Research and Applications at Kyoto University, Dr. Yamanaka is also senior investigator at the Gladstone Institute of Cardiovascular Disease in San Francisco.

Michael Bloomberg, the Mayor of New York City and the founder and majority owner of Bloomberg News, was awarded the Mary Woodard Lasker Award for Public Service in recognition of his numerous efforts to improve public health in the nation’s most densely populated metroplex. Among other accomplishments, Mayor Bloomberg was recognized by the Lasker judges for his advocacy against handguns as well as his eradication of smoking and trans-fats throughout NYC. According to an official Lasker Foundation statement, there are currently 300,000 fewer New Yorkers who smoke today than in 2002, when Bloomberg first took office. As Ms. Freire formally stated, "Michael Bloomberg understood the impact of second-hand smoking on workers, of smoking on individuals, of trans-fats on heart conditions and obesity. It highlights the courage of an individual to look at scientific data and make policies based on the data for the betterment of the health of people." As further described on the Lasker Foundation’s website, Mayor Bloomberg was chosen for the Award, "For employing sound science in political decision making; setting a world standard for the public’s health as an impetus for government action; leading the way to reduce the scourge of tobacco use; and advancing public health through enlightened philanthropy." This is not the first time that Mayor Bloomberg has been honored for his work in this field, as the Johns Hopkins Bloomberg School of Public Health at his alma mater is named in his honor.

The award for clinical medical research was shared by Dr. Brian Druker of the Oregon Health and Science University, Dr. Charles Sawyers of Memorial Sloan-Kettering Cancer Center, and Dr. Nicholas Lyndon, formerly of Novartis, for their collaborative development of Gleevec, which had sales of $3.7 billion in 2008 alone, for the treatment of blood cancers. The drug has proven to be especially effective as a treatment for chronic myelogenous leukemia, which otherwise is a fatal condition but which becomes manageable with Gleevec, which allows patients "to live with the disease as you do with diabetes or high blood pressure," as Ms. Freire explained.

Established in 1942 by the advertising executive Albert Lasker and his wife Mary, a health advocate, the Lasker prizes are awarded every year to living persons who have made significant contributions to medical science or who have performed public service on behalf of medicine. As described on the Foundation’s website, "The Lasker Awards are among the most respected science prizes in the world. Since 1945, the Awards Program has recognized the contributions of scientists, physicians, and public servants who have made major advances in the understanding, diagnosis, treatment, cure, and prevention of human disease. Lasker Awards often presage future recognition by the Nobel committee, so they have become popularly known as ‘America’s Nobels’. Seventy-six Lasker laureates have received the Nobel Prize, including 28 in the last two decades."

Additionally, the Lasker Awards include a cash prize of $250,000 for each category.

Neuralstem Awarded Adult Stem Cell Patent

The company Neuralstem has announced today that it has been awarded a patent for its latest proprietary technology for an adult stem cell therapy that can be used in the treatment of neurological diseases.

Entitled "Transplantation of Human Neural Cells for Treatment of Neurodegenerative Conditions", the patent also covers manufacturing methods and procedures for future related products, and will be in effect through July of 2026.

According to founding president and CEO, Richard Garr, J.D., "We are gratified to add this important core technology patent to our portfolio. The transplantation of our neural stem cells to treat degenerative conditions of the nervous system is at the heart of Neuralstem’s mission."

Although Neuralstem already holds a number of other patents for embryonic stem cell methods and processes in animal models, the company’s human stem cell product does not involve embryonic stem cells but instead is based exclusively upon adult stem cells that are derived from human adult CNS tissue.

With corporate headquarters in Rockville, Maryland, Neuralstem was founded in 1996 by the current president and CEO, Richard Garr, J.D., along with Merrill Solomon. As stated on the company’s website, Neuralstem describes itself as "a biotherapeutics company utilizing its patented Human Neural Stem Cell technology", which "allows for the isolation of CNS (central nervous system) stem cells from tissue; the expansion in vitro of each cell up to a billion billion times (60 doublings), and the controlled differentiation of the cells into mature, physiologically relevant human neurons and glia."

(Please see the related news article on this website, entitled, "Adult Stem Cells Approved for ALS Clinical Trial", dated September 21, 2009).

Horse Benefits From Adult Stem Cells

Continuing with an ongoing trend, and consistent with the latest developments in recent years, veterinary medicine remains several years ahead of human medicine in stem cell therapy.

As the latest development in veterinary medicine, Phil the horse has been treated with his own adult stem cells, derived from his own bone marrow just 2 weeks ago. Having suffered from a lame knee prior to receiving the therapy, Phil is now back to his usual self, unrestricted in motion and painfree. Increasingly, autologous (in which the donor and recipient are the same animal) adult stem cell therapy is being used in animals to treat a wide variety of ailments which include arthritis, tendonitis and even broken bones. Whether the condition is caused by an acute injury or by age-related degenerative conditions such as osteoarthritis, adult stem cell therapy continues to yield remarkable and consistent success in veterinary patients.

According to Martin Vidal, D.V.M., a veterinarian at the UC Davis Center for Equine Health, "The joint is a very delicate environment in horses. The horse has more appropriate mechanical demands than would be comparable to a human. The hope is that the stem cells will incite a reparative process." As Jeff Peck, D.V.M., a veterinarian at the Affiliated Veterinarian Specialists of Orlando, Florida, adds, "We know we’re not going to make those tissues normal, but it will suppress inflammation, slow the progression of degenerative changes in many cases, and also provide pain relief."

As previously reported a number of times on this website, companies such as Vet-Stem in the U.S. and VetCell in the U.K. have accumulated numerous documented cases of the benefits of autologous adult stem cell therapy in animals. To name just a few of the advantages, adult stem cell therapy yields faster healing and shorter recovery times than surgical treatments do, and adult stem cell therapy does not pose a risk of any side effects like medications do. Additionally, since the adult stem cells are autologous, there is no risk of immune injection. The U.K. company VetCell derives the autologous adult stem cells from the animal’s bone marrow, and to date has treated approximately 1,700 horses with an 80% success rate. By comparison, the U.S. company Vet-Stem derives the autologous adult stem cells from the animal’s adipose (fat) tissue, and to date has treated over 2,000 dogs and over 3,000 horses, also with an 80% success rate. With both companies, the procedure is quick, simple, and minimally invasive. Although the treatment is more expensive than conventional veterinary procedures, the adult stem cell treatment actually works, and noticeable improvement is seen almost immediately in all cases, not just in the 80% of cases that exhibit a complete recovery. By sharp contrast, however, conventional surgical and pharmacological therapies, which might initially be less expensive than stem cell therapy, only have a 30% success rate and therefore in the long-term are actually more expensive when repeated treatment is needed, or when improvements are not seen at all. Additionally, reinjury is significantly lower in animals who receive autologous adult stem cell therapy, due to the mechanism of action by which these stem cells activate the healing process. As Dr. David Mountford, a veterinary surgeon and chief operating officer at VetCell, explains, "After 3 years, the reinjury rate was much lower in stem-cell-treated animals: about 23% compared with the published average of 56%" for animals treated with conventional therapies. Furthermore, both VetCell and VetStem report a 100% safety rate. In other words, 80% of the animals treated are found to experience improvement in their condition with a reduction and often a full elimination of the need for medication, while adverse side effects have not been reported in any of the treated animals.

Not only do the stem cells automatically target the injured tissue, but they also stimulate other endogenous stem cells which in turn are mobilized into action and participate in the healing and repair process. Although improvements are usually dramatic and immediate, even after the first injection, additional injections may be necessary, depending upon the age and condition of the animal. Very few animals ever need more than a total or 2 or 3 treatments, however, before they are fully restored to their natural, pain-free state of mobility – which contrasts dramatically with conventional therapies such as most prescription medications which may need to be taken indefinitely, without ever producing any tangible signs of improvement and while even possibly causing further damage to the animal through dangerous side effects and other associated risks.

Ordinarily, injuries of the bones, joints, tendons and ligaments result in scarring of the tissue, which not only prevents full healing but also often leads to further injuries at a later time. Conventional medical therapies do nothing to address the problem of scar tissue directly, and surgical procedures actually make the problem worse by increasing the severity of tissue scarring which in turn merely exacerbates later complications that will inevitably result from the scar tissue, since such tissue can never be fully rehabilitated. Adult stem cell therapy, however, allows for the full and complete healing of tissue without scarring, which not only reduces the risk of re-injury of the same tissue at a later date but also restores full physical performance and function, usually very quickly and dramatically. Such is the case in humans as well as in animals. According to Dr. Robert Harman, veterinarian and founding CEO of Vet-Stem, "Our success in animals is directly translatable to humans, and we wish to share our evidence that stem cells are safe and effective." Additionally, adipose-derived stem cells have been shown in a number of studies to exhibit highly beneficial immunomodulatory properties – which reduce inflammation, among other benefits – in addition to stimulating the regeneration of cartilage and other tissue. (E.g., "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., published in the Journal of Translational Medicine in April of 2009, of which Dr. Harman is a coauthor). As Dr. Harman further adds, "In the last couple of years, evidence has come out that the cells we use reduce inflammation and pain, and help lubricate the joint. About 200,000 hip replacements are done every year in humans. That’s a very good target for someone to look at cell therapy."

Both Vet-Stem and VetCell use exclusively adult stem cells, derived from each animal’s own tissue. Since the cells are autologous (in which the donor and recipient are the same animal), there is no risk of immune rejection. More specifically, the stem cells that are harvested in these procedures are mesenchymal stem cells, which are highly potent adult stem cells that are found not only in bone marrow and adipose tissue but also in umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical and veterinary literature detailing the regenerative properties of mesenchymal stem cells.

No embryonic stem cells are ever used in either Vet-Stem’s or VetCell’s therapies, since embryonic stem cells are highly problematic in the laboratory, whether they are of human or non-human origin. Among other problems, the risk of teratoma (tumor) formation disqualifies embryonic stem cells for use as a clinical therapy, even in animals. Adult stem cells, however, do not pose such risks and are therefore rapidly accumulating a consistent history of successful clinical treatments in veterinary, as well as in human, medicine.

Of course, Phil the horse did not have to worry about an outdated federal regulatory agency preventing him from receiving his own adult stem cells as a therapy, unlike his human counterparts, at least in the United States. Until the U.S. FDA reverses its stance in which it insists that each person’s own adult stem cells must be categorized as a "drug", and therefore regulated as such, there’s not much hope of any human patient in the U.S. being allowed to receive autologous adult stem cell therapy, unless he or she is fortunate enough to be accepted into one of the very few FDA-approved clinical trials that are currently underway – and even then, half of all patients in each clinical trial will end up in the "control group", receiving a placebo instead of the adult stem cell therapy. It is precisely this politically motivated and scientifically erroneous stance by the FDA that is driving many U.S. adult stem cell companies, doctors and patients overseas where adult stem cell therapy is legally available. Fortunately, however, since the U.S. FDA does not govern veterinary medicine, U.S. animals are not forced to travel overseas for medical attention but instead are actually legally allowed to be treated with their own adult stem cells within the borders of the United States. With veterinary applications of adult stem cell therapies, in other words, there is no horsing around.

As Phil the horse would no doubt agree, it would seem as though the U.S. FDA lacks basic horse sense.

Adult Stem Cell Company Reports on Heart Therapy

The Belgian adult stem cell company, Cardio3 BioSciences, today presented an update of its C-Cure adult stem cell therapy for heart failure at the 10th annual conference of the European Society of Cardiology in Barcelona.

Described as a second generation adult stem cell therapy, C-Cure allows the differentiation of a patient’s own (autologous) adult stem cells into "cardiopoietic" cells which then differentiate into new cardiac tissue, thereby repairing heart muscle. The proprietary product is derived from autologous adult stem cells that are harvested from each patient’s own bone marrow and cultured with a patented laboratory technology that yields the new, regenerative cardiopoietic cells. Currently C-Cure is being evaluated for both safety and efficacy in the treatment of heart failure in a double-blind, placebo controlled, randomized, multi-center clinical trial.

The international congress is featuring a number of recent advances in cardiac regenerative therapies, with particular emphasis given to the progress that has been made from first-generation to second-generation products. According to Dr. Christian Homsy, CEO of Cardio3 BioSciences, "The potential of cell therapies for the treatment of heart failure has long been recognized but there have been considerable hurdles to overcome in delivering on the promise. Today’s expert panel was able to provide a thorough review of the advancements in science that have brought about today’s second-generation cell therapies, and to put our product, C-Cure, into context. We believe C-Cure has tremendous potential to realize the promise of regenerative therapies in heart failure, and we look forward to the results of our pivotal trial."

Headquartered in Mont-Saint-Guibert, Belgium and founded in 2007, Cardio3 Biosciences, S.A., describes itself as focusing on "the field of regenerative therapies for the treatment of heart failure." As further described on the company’s website, "C-Cure is a cell therapy based on the usage of autologous stem cells differentiated into cardiac precursors called cardiopoietic cells. This second-generation cell therapy was developed based on research conducted with the Cardiovascular Center of Aalst, Belgium, and the Mayo Clinic of Rochester, Minnesota, USA."

Public Awareness of Cord Blood Opportunities Lagging

In an article entitled, "Lack of patient access limits promising cell therapy", a number of examples are cited in which a simple lack of public awareness about umbilical cord blood is the only thing standing between many patients and adult stem cell therapy.

Such awareness begins with the birth of a child, and whether or not the parents are even informed of their options for storing the child’s umbilical cord blood. Private cord blood banks charge a fee that can be as high as several thousand dollars, while public cord blood banks offer free storage. According to recent surveys, however, nine out of ten parents choose neither option, which means that the umbilical cords – along with all the highly potent adult stem cells that are contained within the cords – are discarded as medical waste. Even when a conscious choice is made to bank umbilical cord blood, many adult patients in hospitals around the nation who could benefit from the cord-blood-derived adult stem cells are unaware that such a possibility exists.

Known to be an extremely rich source of highly potent adult stem cells, umbilical cord blood has a long and carefully recorded history as it has been used for a wide variety of clinical applications for decades, safely and effectively. Additionally, such uses have been routinely reported in the medical literature for more than half a century, predating World War II, and also predating any clear scientific understanding of a human stem cell. With the more recent development of the modern concept of a stem cell, umbilical cord and placental blood are now recognized as excellent sources of adult stem cells that can be used in the treatment of a broad range of diseases and injuries. Furthermore, when one considers the number of births that occur daily, throughout the world, umbilical cord blood represents a virtually limitless supply of versatile adult stem cells which otherwise would simply be discarded as waste. Unfortunately, most of the time, this is exactly what happens.

In 2003, Ryan and Jenny Levine chose not to bank the cord blood of their newly born daughter, deciding that the cost was too high. When another daughter was born in 2006, however, they decided to bank her cord blood, paying the $2,000 fee for a private banking facility in Tucson. When the second daughter was diagnosed a year later with cerebral palsy, she was able to receive stem cell therapy from her own cord blood stem cells.

As an infant the child would only reach for her bottle and toys with her left hand, while her right hand remained clenched to her chest in a fist. Likewise, instead of crawling, the child could only scoot along the floor, with her right leg dragging behind her. Her cerebral palsy was suspected of being caused by an in-utero stroke, which could have left the child crippled for life. Instead, when the child was treated with her own adult stem cells derived from her own umbilical cord blood, she began improving within days. Within two weeks, the stiffness on her right side that had been evident since birth was no longer detectable. She was reinfused a second time with her own stem cells in May of 2008. Today, she is able to catch a ball with both hands, and she uses all four limbs to ride a tricycle. The autologous (in which the donor and recipient are the same person) adult stem cell therapy was performed as part of an FDA-approved clinical trial conducted at Duke University in North Carolina. According to the child’s mother, Jenny, "I tell anyone and everyone who is expecting a child that this is something that they need to at least consider."

Similarly, when Al Copeland of Phoenix was suffering from leukemia in 2007, he faced certain death within days after the bone marrow transplant that he had been awaiting fell through. Although he had never heard of cord-blood-derived adult stem cells, his physicians turned to a public cord blood bank in order to obtain the regenerative cells that saved his life. According to his physician, Dr. Jeff Schriber, who is also medical director of the Banner’s Blood and Marrow Transplant Program, "He didn’t have much time. Fortunately, we were able to get the cord blood quickly." Now that Mr. Copeland has been cancer-free for 18 months, he is a regular, voluntary visitor at Banner’s oncology unit, where he visits and encourages transplant patients, offering a sympathetic ear to their fears and concerns. As Mr. Copeland puts it, "If a poor kid from south Texas can do this, so can you. It’s going to be hard. It’s going to be a struggle. But you can pull it off, man. You can." As 57-year-old Graig Stones listens attentively, Mr. Copeland explains that the stem cells saved his life, adding, "It made me realize there’s a lot more to living than just getting up in the morning, putting on your shoes and socks and going to work each day."

Adult stem cells from umbilical cord blood have already been used to treat more than 70 illnesses over the past two decades, though most people are unaware of such facts. According to the National Marrow Donor Program, the number of units stored in their public network of cord-blood banks, which is now at 150,000, has more than tripled over the past five years, although this represents only 3% of the 4 million births that occur annually in the United States.

In addition to a severe lack of public education on the topic, experts cite two main obstacles that limit the availability of cord-blood stem cells, namely, cost, and an inadequate number of collection sites. The private Cord Blood Registry, based in San Bruno, California, for example, charges a $2,000 collection fee in addition to an annual $125 storage fee, though this guarantees the customer direct and exclusive access to his or her individual adult stem cells throughout the future, whenever necessary. Public cord blood banks, by contrast, allow neither direct nor exclusive accessibility to one’s donated cord blood stem cells, though donation is free, and the stem cells are made available to anyone in the general public who may need adult stem cell treatment. At the time of this writing there are currently only 19 public cord blood banks throughout the U.S., most of which have agreements with hospitals on the east and west coasts but nowhere in between; consequently, availability of their services is virtually nonexistent in other parts of the country. Additionally, the cumbersome amount of paperwork that is required for donation to a public bank is often a strong disincentive for many parents. Among other things, expectant mothers must submit a complete medical history prior to the third trimester of pregnancy and make their own arrangements for mailing the cord blood to the storage facility immediately after birth. Clearly, a donation process such as this would be more efficacious if it were simplified. According to Dr. Jordan Perlow, "Every day I have patients who say, if there’s an easy way I could donate, I’d love to do it," but an easy way does not yet exist. Although in recent years the U.S. federal government has initiated programs to increase public awareness of cord blood banking, in actuality the accessibility of such banking services still lags behind expectations. Since only 17 states have passed legislation requiring expectant mothers to be informed of cord blood preservation options, most new parents are still unaware that such possibilities even exist.

Advocates of public cord blood banking point out that the services have already saved numerous lives, even though the system is far from perfect. The highly potent mesenchymal stem cells that are found in cord blood are "immune privileged", meaning that they do not require an identical matching to the recipient, as bone marrow does, and therefore even one donated cord blood unit can potentially treat a large number of people, for a wide variety of illnesses and injuries.

In 2008, the National Marrow Donor Program, a Minnesota-based non-profit organization that handles requests for all publicly available cord blood, provided cord blood units for the treatment of nearly 900 people, signifying a 40% increase over 2007. Still, public cord blood banking remains significantly less popular than private banking, despite the difference in cost. New business models have been proposed for the public banking systems, which have set a goal of doubling their number of units, to 300,000, by 2015. Because the public banks bear the entire cost of the services, however, the question of funding is a serious one. By contrast, the Cord Blood Registry, which is the oldest and largest private cord blood bank in the world, already has over 270,000 cord blood samples in its inventory, which is 80% more than the number of samples in the "Be the Match" public-donor network. According to Tom Moore, CEO of the Cord Blood Registry, there has been a consistent 30% annual growth at the Registry over the past several years.

Nevertheless, private cord blood banks are increasingly attracting criticism for their exclusivity, as critics are increasingly encouraging a wider use of the more open services offered by public banking companies. In a policy statement issued in January of 2007 by the American Academy of Pediatrics, for example, it was estimated that the odds of any particular child actually needing to be treated with his or her own cord blood ranged from 1 in 1,000 to 1 in 200,000. There are therefore many physicians who agree with the Academy in urging greater use of public banks over private banks, since it is only the units stored in public banks which are made available to any patient anywhere who may be in need of adult stem cell treatment.

Umbilical cord blood has been documented in the peer-reviewed medical literature for its broad range of clinical therapeutic applications for over half a century, long before the concept of a stem cell became a topic of general interest. Today, a number of clinical trials are being conducted in which cord-blood-derived stem cells are being studied as a treatment for a wide variety of diseases and injuries, as these highly versatile adult stem cells are proving to hold greater, more concrete and more tangible therapeutic value than embryonic or iPS (induced pluripotent stem) cells, both of which are still in the experimental stages.

Unfortunately, neither the popular media nor, therefore, the general public, seem to be aware of such facts.

Adult Stem Cells Treat Heart Failure

In 2007, Thomas Clegg was diagnosed with dilated cardiomyopathy, a condition in which the left ventricle of the heart becomes abnormally enlarged. At that time, his ejection fraction – a measure of the heart’s efficiency at pumping blood – was around 9 (nine) percent, whereas a normal ejection fraction is considered to be between 50 and 65%, or higher.

As Mr. Clegg describes, "I was one of the lucky ones. I was still working 8 hours a day. Some people who have 30% ejection fractions can’t walk across the room."

One of his physicians, Dr. Kevin Lisman, informed Mr. Clegg that his best option would be a heart transplant. However, precisely because of the fact that Mr. Clegg was still able to work and remain physically mobile throughout the day, he was very low on the list of recipients, since other people who were in worse condition took precendence.

Then, another option was offered to Mr. Clegg: autologous adult stem cell therapy. Mr. Clegg eagerly accepted the option. According to Dr. Brian Bruckner, who conducted the adult stem cell procedure at the Methodist DeBakey Heart and Vascular Center in Houston, "He didn’t really have a lot of options. Injecting cells directly is kind of a novel idea. We know they help, but we’d like to know more about that mechanism." As Mr. Clegg adds, "My wife and I just wanted to see what was going on. At this point, I would have had to get worse to get a transplant."

In an FDA-approved, Phase II, double-blind, placebo-controlled, multi-center clinical trial in which approximately 40 patients throughout the country participated, Mr. Clegg was the first to receive the adult stem cell treatment, which consisted of treating Mr. Clegg with his own (autolgous) adult stem cells that were harvested from his own bone marrow via his hip. After the doctors in Houston removed 50 milliliters of Mr. Clegg’s bone marrow, it was shipped to Aastrom Biosciences in Ann Arbor, Michigan where the adult stem cells were isolated, expanded and returned to Mr. Clegg’s doctors, who administered the cells directly into Mr. Clegg’s heart.

According to Aastrom CEO George Dunbar, "Lifesaving is where we wanted to focus our efforts. It helps with what nature already does with these mixed cell populations."

Now, nine months after receiving the autologous adult stem cell treatment, Mr. Clegg’s ejection fraction has increased to 30%.

Mr. Clegg has nothing but the highest praise for the medical team in Houston, especially his nurses. As he emphatically states, "They’re my guardian angels. What they’re trying to do is back the clock up. I honestly feel like this has added some time."

Russian Stem Cell Company Plans IPO

The Human Stem Cell Institute of Russia has announced that it is seeking 150 million rubles (4.75 million USD) from investors. The annnouncement heralds the first IPO by any company in Russia in more than a year.

The announcement also constitutes an encouraging sign that Russia’s economy is recovering from recession.

Headquartered in Moscow, the Human Stem Cell Institute was founded in 2003 and has been valued at 500 million rubles. The Institute houses a repository of adult stem cells derived from human umbilical cord blood, from which researchers at the Institute are also in the process of developing therapeutic applications. Currently the Institute comprises the largest stem cell bank in Russia. According to Artur Isayev, the Institute’s CEO and primary share holder, "The IPO would be the first by a Russian biotechnology company and the first by any Russian company this year". According to Maxim Dryomin, corporate finance director at the Alor Group, which is organizing the IPO, "We are counting on fairly major investors. Now there is a big number of well-to-do people who are looking for direction for their investments."

Russia has not been immune to the global economic crisis that has afflicted most of the world’s countries over the past year, but signs of a recovery in the former capital of the Soviet Union are now evident. The Russian economy is heavily based upon natural resources, which played a major role in throwing the country into recession in the second half of 2008 when prices of natural resources suddenly collapsed. The Russian government is now exploring new strategies for diversifying the national economy away from natural resources, and the biotech industry holds particular appeal.

Although the Human Stem Cell Institute is widely regarded with respect among the scientific community, in the past there have been some questions concerning the legitimacy of various types of stem cell "therapies" that are available in Russia. A March 14, 2005 article by the Associated Press, for example, reported that "dozens of Russian clinics and beauty salons claim they are already using both adult and embryonic stem cells to treat everything from wrinkles to Parkinson’s disease to impotence. Scientists warn that while stem cells are still being researched in laboratories, treatment by clinics claiming to use stem cells may cost patients their health and fortunes. Moreover, they say, even though it’s illegal, enforcement is lax and no one knows if the injections patients are getting contain stem cells." As the 2005 article continues, "When Svetlana Galiyeva found a clinic offering to treat her multiple sclerosis with embryonic stem cells, she grabbed the opportunity. Twenty-thousand dollars later she is still in a wheelchair and desperate. And there is no proof her injections had anything to do with stem cells." According to Vladimir Smirnov, director of the Institute of Experimental Cardiology as well as of an adult stem cell bank in Russia, who was interviewed in the 2005 A.P. article, "No one has been given any licenses for injecting the stem cells. These are only experiments. This is all being done at their own risk. This is all illegal." Although there are several state-run research institutes in Russia which have been attempting for the past few years to offer treatment with adult stem cells derived from bone marrow and fat, the authenticity of treatments offered by independent clinics in Russia cannot be verified. According to Andrei Yuriyev, deputy head of the Federal Health Care Inspection Service in Russia, Russian law permits only the extraction and storage of stem cells, not their use in treatment. Consequently, as of the 2005 A.P. article, Yuriyev was already investigatiing nearly 20 clinics throughout Russia claiming to offer various types of illegal stem cell therapies. As Dr. Alexander Teplyashin, who has been offering therapies in Russia with adult stem cells derived from bone marrow and fat, told the A.P. in 2005, "We are taking advantage of the loopholes in the law. What is not forbidden, is allowed."

On the global stage, at least in the field of cord blood banking, Russia’s Human Stem Cell Institute will be competing against the Cryo-Save Group of Europe and Cryo-Cell International, although neither of these companies are aggressively developing therapies, as the Human Stem Cell Institute is doing.

Although some of Russia’s larger companies are also beginning to attract investors from both domestic and international markets, there are other businesses which are still lagging behind expectations, however. The Russian fertilizer company, Acron, for example, has postponed a London float, opting instead for a placement of Global Depository Receipts. Similarly, the state-run rail monopoly, Russian Railways, has announced a delay of its IPO until 2011. Following the same trend, Metalloinvest, the iron ore and steel firm, has scrapped IPO plans altogether, as has the company Strikeforce Mining and Resources, owned by the Russian billionaire Oleg Deripaska.

With facilities currently located only in Moscow, the Human Stem Cell Institute plans to expand into Belarus and Kazakhstan. Funding from the IPO has been designated for the Institute’s R"D of adult-stem-cell-based therapies in the treatment of a wide variety of ailments, including cancer.

As CEO Artur Isayev explains, he expects the Institute’s sales and profits to increase by 30 to 40% per year, over the next few years.