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.

India Boasts Profitable Adult Stem Cell Market

In sharp contrast to the regulatory setbacks experience in other nations, such as the U.S., India offers a commercially and legally attractive environment for adult stem cell entrepreneurs.

At last count, at least 15 new firms are scheduled to enter the Indian market, and 4 already existing firms are planning major expansion. In the latter category are Reliance Life Sciences, LifeCell International, Regenerative Medical Services, and Cryo-Save India. Though each of these companies is already supplying cell cultures to select hospitals, they are all planning even further expansion.

According to the Indian Council for Medical Research (ICMR), the 15 new firms who are scheduled to enter India’s market include private commercial ventures as well as academic research institutions. Additionally, a number of organizations are conducting clinical trials with adult stem cells in India, including but not limited to Stempeutics, the LV Prasad Eye Institute, the Nichi-In Centre for Regenerative Medicine, the Centre for Cellular and Molecular Biology, the National Centre for Cell Science, and Manipal Hospital in Bangalore, among others. According to the ICMR, at least 60 adult stem cell clinical trials are currently underway in India, most of which involve autologous (in which the donor and recipient are the same person) adult stem cells, and all of which are approved by the Drug Controller General of India. The entire field of adult stem cell therapy has enjoyed a new boost in India as a result of the recent decision by the Indian government to allow the patenting of micro-organisms and related laboratory processes.

According to Mayur Abhaya, executive director of LifeCell International, based in Chennai, the greatest therapeutic value thus far has been found in the type of adult stem cell known as mesenchymal stem cells (MSCs), which are already being used by doctors in hospitals in India to treat a wide variety of ailments, which include diabetes, heart disease, stroke, arthritis, multiple sclerosis, spinal cord injury, and blood disorders, to name a few.

LifeCell, which is currently the leading company in India for the storage of umbilical cord blood stem cells, has already banked cord-blood-derived stem cells for more than 12,000 clients. The company, which is also collaborating with Cryo-Cell in the U.S., is now planning to expand into the collection and storage of adult stem cells derived from bone marrow aspirate. Additionally, LifeCell has also begun clinical trials with Harvest Therapeutics in the treatment of critical limb ischemia with adult stem cells, and is planning further expansion into the storage of menstrual blood, now known to be a rich source of highly potent adult stem cells. As Mayur Abhaya further explains, "A few more clinical trials are being planned in other disease settings, apart from the proposed collaboration with Cryo-Cell to launch the menstrual blood stem cell banking service in India."

With a population of approximately 1.2 billion people, India ranks as the second most populous nation on earth, and the world’s most populous democracy. Second only to China, whose population is estimated at 1.3 billion people, India actually offers a larger and freer commercial market than can be found in China, which is still formally Communist and is therefore still highly restricted in the nature and extent of its commerce. It is hardly surprising, therefore, that entrepreneurs of all types eventually cast a serious eye toward India. Especially with the outdated federal regulatory laws that still govern medical research in other countries, such as the U.S., it is only logical and to be expected that adult stem cell companies would discover in India a welcoming atmosphere in which they are able to thrive.

Adult Stem Cells Perk Up Pooch

Micki, an 11-year-old German Shepherd in Vancouver, Canada, had developed age-related osteoarthritis in 3 legs. As a result, the dog underwent a ligament operation that was not entirely successful and was accompanied by daily, heavy doses of anti-inflammatory medication, prescribed for indefinite use. Occasionally, Micki was in so much discomfort that a leg brace was required. When a second operation was prescribed for the ligament of a different leg, the dog’s owner, Sandy Draibye, a lawyer, decided that enough was enough. Instead of consenting to further surgery for her dog, Sandy opted for autologous adult stem cell therapy instead.

As Micki’s vet, Amanda Booth, explained, "This is her kid." Although Dr. Booth was personally unfamiliar with the stem cell treatment, she agreed to learn how to administer it anyway. She then harvested adipose (fat) tissue from the dog’s thigh and sent the tissue to the U.S. company Vet-Stem in California, where the stem cells are isolated and returned to Dr. Booth within 48 hours for injection directly into the dog’s injured ligaments and joints.

According to Dr. Booth, "If the other three legs had been in good shape, I would have held off on the stem cell surgery. I researched it before I agreed to do it. My first criterion was finding someone other than the company that says it works." After receiving a number of enthusiastic responses from other vets, Dr. Booth decided to take the plunge and begin acquiring her own experience with the procedure.

As previously reported a number of times on this website, the U.S. company Vet-Stem continues to see consistently high success rates in both canine and equine clinical applications, with an 80% efficacy rate and a 100% safety rate in the animals that are treated with Vet-Stem’s autologous adult stem cell procedure. 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.

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.

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."

Vet-Stem uses 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 Vet-Stem’s procedure are mesenchymal stem cells, which are highly potent adult stem cells that are also found in bone marrow and 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 Vet-Stem’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.

According to Sandy Draibye, owner of Micki, the 11-year-old German Shepherd, "It’s a lot of money, but she’s a lot of dog. I am not wealthy, but I can afford it. Everybody adores their dog. I don’t think they would give it a second thought."

In fact, as Sandy points out, most humans are so impressed by the news of such dramatic recovery in animals that people are becoming increasingly curious about the use of autologous adult stem cell therapy for the treatment of human ailments. As Sandy adds, "They’re wondering about their own joints."

More Veterinary Success Seen With Adult Stem Cells

Even at five years of age, Lucy the Labradoodle was suffering from rheumatoid arthritis in her hind legs. But now, after receiving autologous adult stem cell therapy, she is showing significant improvement. According to her owner, Carol Fischman of Vero Beach, Florida, "We didn’t think she’d live anywhere near this long, and I know it’s because of the stem cells."

According to Dr. Kristin Kirkby, the veterinarian who performed the procedure, "I think it’s an exciting field. Undoubtedly the future of scientific research is going this way. It’s early on, especially on the small-animal side, to know what the results can be." But nevertheless, the results are consistently, dramatically, positve.

As previously reported a number of times on this website, an increasing number of veterinarians are finding success in the use of autologous (in which the donor and recipient are the same animal) adult stem cells for the treatment of a wide range of conditions in animals. Companies such as Vet-Stem in the U.S. and VetCell in the U.K. have developed procedures that are easily utilized by veterinarians and which are becoming increasingly popular as news of the success of such a technique continues to spread. The procedure that Dr. Kirkby used on Lucy the Labradoodle involved harvesting a small sample of the dog’s adipose (fat) tissue, which was then shipped to Vet-Stem’s laboratories in California where the dog’s own adult stem cells were isolated, purified and returned within 48 hours to Dr. Kirkby who administered the stem cells directly to the dog. So far Lucy has received 3 treatments with her own stem cells, and has shown such improvement that her owners are considering a fourth treatment.

Vet-Stem began treating animals in 2003, primarily horses for injuries and dogs for age-related osteoarthritis. To date Vet-Stem has now treated over 3,500 horses and 2,000 dogs, and the treatment of cats is planned for later this year. Approximately 1,500 vets throughout the U.S. are licensed by Vet-Stem to conduct the procedure. In all cases, adult stem cells are harvested from the animal’s own adipose tissue, which is a rich source of the highly potent adult stem cells known as mesenchymal stem cells. In no case are embryonic stem cells ever used, since embryonic stem cells remain highly problematic and are known to cause teratomas (tumors), among other problems, which therefore disqualifies embryonic stem cells as a treatment for animals as well as for people.

According to Dr. Bob Harman, a veterinarian and founding CEO of Vet-Stem, "Really, all we’re doing is harnessing the existing repair machinery in the body, concentrating it, and putting it right where an injury occurs, where healing is needed, to heal naturally."

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, and such properties are well documented in the medical literature. (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 explains, "In the last couple of years, evidence has come out that the cells we use reduce inflammation and pain, and help lubricate the joint." 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. 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. As Dr. Harman succinctly states, "Our success in animals is directly translatable to humans, and we wish to share our evidence that stem cells are safe and effective."

Although Vet-Stem was the first company to commercialize the process in the U.S., and VetCell was the first to do so in the U.K., a number of other companies throughout the world are now also utilizing similar types of technology in which adult stem cells are derived from each animal’s own tissue and readministered to the animal as a clinical therapy for the particular medical condition from which the animal suffers. Autologous adult stem cell therapy has proven to be a highly preferable alternative treatment for many animals, especially those whose conditions require surgery or anti-inflammatory drugs, both of which can often be avoided with the stem cell therapy.

Dr. Adam Gassel, a veterinarian in Irvine, California, has treated nearly 40 dogs with Vet-Stem’s procedure and is now a strong believer in the therapy, despite his initial skepticism. As Dr. Gassel explains, "I was pretty skeptical. I was hoping that dogs would just be more comfortable." But of all of his canine patients who have received the adult stem cell treatment, 80% have shown significant improvement, approximately half of whom have been able to stop taking medication, and approximately a fourth of whom have completely returned to their normal activities.

The procedure that Vet-Stem has literally distilled to a science is quick, simple, minimally invasive, safe, highly effective, and while it is not cheap, it is less expensive than conventional surgical and pharmaceutical therapies which may not be effective at all. The first stem cell extraction and transplant for a dog typically run between $1,500 and $2,500, although subsequent transplants will often cost much less since extraction is only necessary once. The entire stem cell extraction procedure consists of the approximate equivalent of 2 to 3 tablespoons of the animal’s own adipose (fat) tissue which is surgically removed under anesthesia and shipped overnight to Vet-Stem’s laboratories in southern California where the stem cells are processed and returned two days later to the veterinarian who injects the stem cells back into the animal at the site of injury. Not only do the stem cells automatically target the injured tissue, but they also stimulate the animal’s 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 particular 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 sharply 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.

It is worth emphasizing the point that Vet-Stem uses 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 Vet-Stem’s procedure are mesenchymal stem cells, which are highly potent adult stem cells that are also found in bone marrow and umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of mesenchymal stem cells.

No embryonic stem cells are ever used in Vet-Stem’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, whether for humans or 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.

A number of companies throughout the world are replicating the procedure pioneered by Vet-Stem. It is fortunate that such companies are able to conduct their business without the same burdensome federal legislation that continues to impede progress in human medical adult stem cell therapies in the United States. Consequently, veterinary stem cell therapy has been applied very aggressively to animals, especially to the expensive, large animals such as competitive horses whose lives and careers have literally been saved by such therapies. Even for dogs who do not earn large salaries in high-profile competitions but who are merely beloved pets, autologous adult stem cell therapy has also proven to be life-saving. Meanwhile, in human medicine, however, nothing whatsoever has been allowed to happen in U.S. clinics outside of a small number of government-approved clinical trials, thanks to an outdated, lengthy, lethargic and prohibitively expensive FDA approval process. It is hardly surprising, therefore, that veterinary stem cell medicine has quickly outpaced human stem cell medicine – but now, at last, humans are beginning to learn something from their canine and equine friends.

And the market is huge. Both for humans as well as for animals, the potential commercial market is virtually limitless and thus far untapped. According to Dr. Charles Fischman, an immunologist and one of the owners of Lucy the Labradoodle, "I like the dog as much as I like my kids. People will spend more on their dogs than they will on themselves."

Adult Stem Cells Heal Arthritic Dog

Olli, a 12-year-old Gordon Setter in Ontario, was suffering from arthritis in his left knee and right hip. Within eleven days of receiving injections of his own adult stem cells, however, Olli is now showing significant improvement.

His vet, Dr. Melissa Boyle, is one of 26 veterinarians in Canada who have been qualified by the U.S. company Vet-Stem to administer the therapy, in which adult stem cells are derived from each animal’s own adipose (fat) tissue.

According to Dr. Deborah Boyd – Olli’s owner, a vet herself and the owner of the Grey Bruce Pet Hospital where Olli was treated – conventional veterinary therapies were ineffective in treating Olli and in fact his condition only worsened in response to such therapies. Now, after having tried adult stem cell therapy on Olli, Dr. Boyd is so pleased with the results that she asked her own physician why the same type of autologous adult stem cell therapy is not available for people. In response, as Dr. Boyd explains, "She just looked at me and said, ‘You veterinarians, you’re 10 years ahead of us.’"

Although the cost of the veterinary stem cell treatment runs between $1,500 and $2,500, conventional veterinary knee surgery for a dog of Olli’s size would have cost between $1,500 and $3,000 or more and also would have required expensive and dangerous medications for an indefinite period of time. Furthermore, the success rate of conventional surgeries and medications is much lower than that of adult stem cell therapy. Additionally, should the animal need future stem cell treatments, Vet-Stem’s fees also include banking services for 4 more doses of the animal’s stem cells at Vet-Stem’s laboratories in San Diego for the next year, after which time customers have the option of continuing to bank the cells at an annual fee of $120.

Dr. Thomas Koch, a researcher at the University of Guelph, recently received a 3-year post-doctoral fellowship worth more than $1 million for the research and development of adult stem cell therapies in the treatment of cartilage injuries in horses. (Please see the related news article on this website, entitled, "Canadian University Announces Major Adult Stem Cell Research Award on Horses", dated July 18, 2009). According to Dr. Koch, who was asked to comment on Vet-Stem’s therapy for dogs, "There doesn’t seem to be any adverse effects."

Indeed, as previously reported a number of times on this website, the company Vet-Stem continues to see consistently high success rates in both canine and equine clinical applications, with an 80% efficacy rate and a 100% safety rate in the animals that are treated with Vet-Stem’s autologous adult stem cell procedure. 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. Now, such applications are being repeated by other veterinarians and clinics around the world.

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.

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 sharply 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."

Vet-Stem uses 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 Vet-Stem’s procedure are mesenchymal stem cells, which are highly potent adult stem cells that are also found in bone marrow and umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of mesenchymal stem cells.

No embryonic stem cells are ever used in Vet-Stem’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.

As numerous reports about more and more pioneering canine patients such as Olli continue to make their way into the veterinary literature, perhaps humans could also learn to benefit from such reports. After all, with enough patience, perseverance, and repetitive training, perhaps it might actually be possible for a few dogs to teach a few old humans some new stem cell tricks.

Novartis Acquires Opexa’s Adult Stem Cell Technology

The biotech companies Novartis and Opexa Therapeutics have signed an agreement in which Novartis will pay $4 million for Opexa’s novel adult stem cell technology.

The deal includes $3 million paid up-front, with an additional $1 million in fees that will be distributed over 6 months. Additional future milestone payments are estimated to exceed $50 million, not including royalties.

Novartis will be responsible for the funding of all R&D as well as commercial activities of Opexa’s technology, which enables the production of monocyte-derived stem cells (MDSCs) from blood. Currently the technology is in preclinical development where it was been shown to generate MDSCs from peripheral blood mononuclear cells.

As described on their website, "Opexa is focused on the development of patient-specific cellular therapies for the treatment of autoimmune diseases including multiple sclerosis and diabetes. The company’s lead product is Tovaxin, a T-cell MS vaccine that is specifically tailored to each patient’s disease profile. In October 2008 the company reported positive top-line results from a Phase IIb study in early, relapsing MS patients."

Formed in 1996 through the merger of the two companies Ciba-Geigy and Sandoz, Novartis is one of the world’s largest multinational corporations and a leader in healthcare, offering products and services in pharmaceuticals, vaccines and diagnostics. In 2008, Novartis invested $7.2 billion in its R&D, and that same year the company was ranked number 2 in Fortune magazine’s "World’s Most Admired Companies" survey. Novartis currently employs approximately 100,000 people in 140 countries worldwide.

Stem Cell Therapies Are Not Just for the Dogs

Prior to being diagnosed with severe arthritis last year, Ezri used to compete in agility contests. But then the ten-year-old Border Collie began slowing down and showing signs of pain in her front paws. According to Ezri’s owner, Kim Galusha, "She was limping and we tried all kinds of different pain medications and arthritis treatments but nothing helped. She got to the point where all she wanted to do was sleep on the couch."

Thanks to veterinary surgeon Dr. Stephen Kerpsack, however, the dog underwent a successful autologous adult stem cell transplant. Dr. Kerpsack derived approximately 2 tablespoons of fat from Ezri’s abdominal adipose (fat) tissue, which was then mailed the the Vet-Stem laboratory in San Diego where the adult stem cells were isolated, expanded and returned within 48 hours to Dr. Kerpsack who injected the adult stem cells directly into the arthritic joints of Ezri’s front legs. Within 4 to 6 weeks, Ezri was back to her usual self. According to Kim, "You could just tell she had a real big attitude change. She wanted to play."

As Dr. Stephen Kerpsack explains, "In that fat are what are called stem cells. The stem cells have the ability to become other types of cells, which can repair tissue in the body."

As previously reported a number of times on this website, the company Vet-Stem continues to see consistently high success rates in both canine and equine clinical applications, with an 80% efficacy rate and a 100% safety rate in the animals that are treated with Vet-Stem’s autologous adult stem cell procedure. 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.

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.

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 sharply 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."

Vet-Stem uses 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 Vet-Stem’s procedure are mesenchymal stem cells, which are highly potent adult stem cells that are also found in bone marrow and umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of mesenchymal stem cells.

No embryonic stem cells are ever used in Vet-Stem’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.

Adult Stem Cells Act as Pacemaker

Scientists at the Chiba University Graduate School of Medicine in Japan have announced their discovery of a natural "biological pacemaker" in adult stem cells derived from adipose (fat) tissue. Specifically, the adult stem cells are mesenchymal stem cells (MSCs), and their naturally occurring "pacemaker" qualities may someday be useful in correcting electrical problems in the heart.

According to Dr. Toshinao Takahashi of the Chiba University, "Electronic pacemakers are often used as palliative therapy for people who have conduction problems with the electrical signals that govern the heart beat. However, that therapy has several shortcomings, including possible malfunction and the need for repeated replacement of the device’s power packs and electrodes. Cell therapy could overcome those problems and provide a possible cure for conductive disease. Our goal is to create a biological pacemaker."

The researchers harvested MSCs from the adipose tissue of mice which were then differentiated into beating cells which resembled heart cells in all features including cell surface proteins that serve as cardiac chemical markers. The new cells were then injected into mice who suffered from atrioventricular (AV) block, an electrical signaling problem of the heart which results in an abnormally reduced heart rate. Within a week after treatment with the new cells, the AV block was reversed to some extent, either completely or partially, in half of the mice who received the stem cell transplant.

Adipose tissue is known to be a rich source of MSCs which have been shown in numerous studies to differentiate into a wide variety of tissue types such as bone, muscle, liver, neuron and cardiac cells, among others. As the name implies, MSCs possess qualities of the "mesenchyme" – the unspecialized matrix cells that are found in the early embryo – which is in fact derived from all 3 germ layers, so one would therefore logically expect MSCs to be able to differentiate into most if not all cell and tissue types of the adult human body. Additionally, adipose tissue is known to exhibit a number of unique immunomodulatory properties which would also prove to be especially beneficial in the treatment of a variety of diseases and injuries (as recently reported by N.H. Riordan et al. in a publication in the April 24, 2009 issue of the Journal of Translational Medicine entitled, "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis").

In the particular treatment of disorders stemming from problems in cardiac electrical conduction and signaling, Dr. Takahashi has concluded that, "Our findings suggest that brown-fat-derived mesenchymal stem cells may become a useful cell source for antiarrhythmic therapy."

The results were presented at the American Heart Association’s Basic Cardiovascular Sciences Conference in Dallas.

NeoStem Featured on CBS

The first company to commercialize a method by which healthy adults may bank their own stem cells, NeoStem was the subject this past Sunday of the CBS television feature, "Eye on New York City".

NeoStem has pioneered a process by which endogenous adult stem cells that naturally reside in the bone marrow are "mobilized" to migrate into the peripheral blood, from which they are then collected through a process known as apheresis. Routinely used in other procedures such as the donation of blood platelets, apheresis allows stem cells to be easily separated from the other cells in the blood, so that the non-stem-cell cells may then be returned to the individual after the stem cells are removed. Apheresis is a minimally invasive, painless process that typically lasts approximately 3 to 4 hours, during which time the patient is awake and comfortable – all of which is highly preferable to bone marrow aspiration, the procedure for harvesting adult stem cells from bone marrow but which must be performed under general anesthesia due to the high level of pain that it causes. After the adult stem cells are collected via apheresis, the stem cells are then stored via a cryopreservation method and remain available to the individual indefinitely throughout the future for therapeutic use whenever needed.

According to Dr. Max Gomez, medical expert for CBS, autologous adult stem cells "have become the cutting edge way to treat osteoarthritis of the knee, hip, ankle and even back pain", among other ailments. Additionally, he adds, "The promise appears to be so great that more than 1,000 clinical trials are testing (autologous adult) stem cell therapies for various conditions and showing promising results for heart failure, diabetes, lupus and even macular degeneration", among other conditions.

According to Dr. Robin Smith, CEO of NeoStem, "NeoStem is very focused on autologous adult stem cell therapies being developed for multiple diseases." Among NeoStem’s recent acquisitions is an exclusive license for use of the technology which identifies and isolates VSELs (very small embryonic-like stem cells), which are not actually embryonic stem cells but nevertheless resemble embryonic stem cells in their pluripotency, and which are believed to have a number of potential clinical applications to the treatment of various diseases.

According to the company’s website, "NeoStem is the first company to provide adult stem cell collection and banking services to the general adult population. NeoStem’s medically proven process is a minimally invasive, painless and safe way to collect your adult stem cells. … There are tremendous clinical and economic advantages to autologous stem cell transplantation (receiving your own stem cells) as there are no issues with immune rejection. Engraftment with your own stem cells is faster, safer and much less costly than receiving someone else’s stem cells (allogeneic)." Additionally, as NeoStem points out on their website, "Currently, adult stem cell transplants have been successfully used as the standard of care in treating blood cancers such as leukemia, lymphomas and multiple myelomas. Today, over 2,000 clinical trials are being conducted in the United States looking at treatments for other diseases such as heart disease, diabetes, vascular disease, autoimmune disorders such as lupus, multiple sclerosis, Crohn’s disease, and many more. In addition, adult stem cells are now being used for certain cosmetic procedures and evaluated for further ones."

According to the actress Suzanne Somers, who has utilized NeoStem’s services for banking her own adult stem cells, "Stem cell therapy is the most exciting new breakthrough in medicine. It gives me great peace of mind to know that my own stem cells will be banked as bio-insurance for me. Now I am prepared for my future as the beneficiary of medical benefits while I am alive."

In June of this year, NeoStem signed an exclusive 10-year-long contract with the China-based company Enhance Biomedical Holdings for a collaboration in the development of a network of adult stem cell collection and treatment centers in Taiwan and throughout a number of provinces in China. (Please see the related news articles on this website, entitled "NeoStem Signs Adult Stem Cell Agreemenet in China", dated June 15, 2009, and "NeoStem CEO Invited to Address Medical Tourism at Conference", dated September 8, 2008).

Enrollment Begins in Adult Stem Cell Clinical Trial for Ischemic Stroke

The Canadian company Stem Cell Therapeutics (SCT) has received authorization from the Drug Controller General of India (DCGI) to begin enrollment in the Phase IIb clinical trial for the treatment of acute ischemic stroke with adult stem cells.

The double-blind, randomized, placebo-controlled clinical trial, which has a recruitment target of 128 to 130 patients, will utilize the modified REGENESIS proprietary protocol developed by SCT. Dr. Steven C. Cramer from UC-Irvine and Dr. Michael D. Hill of the University of Calgary are the two principle investigators of the study.

According to Dr. Alan Moore, president and CEO of SCT, "Approval from DCGI to initiate recruitment for the modified REGENESIS stroke trial in India is an exciting milestone for SCT. Jurisdictional approvals have now been granted in India, the U.S. and Canada, therefore we will begin recruiting patients as soon as possible."

In accordance with their regulations, the DCGI states that, "The DCGI approval process categorizes clinical trials into two types. If the study protocol has already been approved by a cognizant regulatory authority in one or more developed countries (such as the U.S., Canada, the U.K., Switzerland, Germany, Australia, Japan, and South Africa), the study is classified as a Type A trial and can be approved using a fast-track process within two to six weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally 8 to 12 weeks. The Institutional Review Board (IRB) approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting study protocols in place and quickly initiating the trials." In other words, India is an excellent place in which to conduct clinical trials, since the approval process moves much more quickly than it does in many other countries. A number of businesses from the U.S., the U.K. and Europe are therefore turning to countries such as India for the testing and commercialization of their new medical products, whether related to stem cells or not.

In this particular case, the therapeutic product developed by SCT, known as REGENESIS, contains a proprietary combination of compounds which are designed to stimulate the body’s naturally occurring, endogenous adult stem cells for the healing and repair of damaged tissue. As described on the company’s website, "Stem Cell Therapeutics Corp. is a Canadian public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells. The Company’s programs aim to repair brain and nerve function lost due to disease or injury. The Company’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS."