Cleveland Clinic receives $2.75M grant to study stem cell use in treating MS

The use of stem cells for multiple sclerosis can be categorized into two main approaches. The first involves transplantation of blood making stem cells, called hematopoietic stem cells, after the immune response of the patient is destroyed. This is performed because multiple sclerosis is an immunological disease in which the T cells are attacking the "insulator" of the nerves, a protein called myelin basic protein. By destroying the immune system and subsequently adding stem cells that will make a new immune system, this approach "resets the clock" and has yielded success in early clinical studies. Unfortunately, the problem with destroying the patient immune system is that they undergo a period of immune compromise during which they are susceptible to bacterial, fungal, and viral infections. The second method of using stem cells in multiple sclerosis is to administer a type of stem cell called mesenchymal stem cells, which actually reprogram the pathogenic T cells so that they slow down their immune attack. Mesenchymal stem cells also possess two other important properties: a) they induce the generation of T regulatory cells, which block pathologic T cells from attacking myeling&; and b) they help to regenerate the injured neurons through producing growth factors, as well as becoming new neurons.

For the study of this second approach, the Cleveland Clinic has received a $2.75 million federal grant from the Department of Defense. This is a 4-year grant that will fund a 24-patient study which will be conducted by the Center for Stem Cell and Regenerative Medicine. The study will investigate patients with relapse-remitting MS that are still able to walk but have moderate to severe disability. Collaborators in the study will include the stem cell company Athersys Inc., Case Western Reserve University, the Clinic, Ohio State University and University Hospitals Case Medical Center.

"Mesenchymal stem cells are primitive cells in the bone marrow that have a wide range of effects that decrease the activity of immune cells which are over-active in MS," said Dr. Jeffrey Cohen of the Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research. "In addition, in numerous laboratory studies, MSC’s were able to migrate from the blood in to areas of inflammation or injury in the nervous system and reduce damage by developing into cells resembling neurons (nerve cells) and glia (support cells) and, probably more importantly, by creating a tissue environment that encourages intrinsic repair mechanisms," he said.

The proposed study is similar to work performed by the Cellmedicine (www.cellmedicine.com ) stem cell treatment clinic which has published on 3 patients with MS undergoing a recovery after treatment with their own fat derived stem cells, without immune suppression. This was published with collaborators at the company Medistem Inc, the University of California San Diego, Indiana University, the company Vet-Stem and the University of Utah. The publication is freely available at this link www.translational-medicine.com/content/7/1/29.

The use of fat as a source of mesenchymal stem cells for treatment of MS is appealing for several reasons. Firstly, the high content of these stem cells in the fat makes expansion of the cells unnecessary for certain uses. The process of cell expansion is technically complex and can only be performed at specialized institutions with experience in cell processing. Secondly, fat contains high concentrations of T regulatory cells, therefore in addition to administering mesenchymal stem cells, the presence of these T cells is theoretically beneficial since they are known to inhibit pathological immune responses. An explanation of the importance/relevance of T regulatory cells in fat is provided in this video:

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Other cells found in fat include endothelial progenitor cells (EPC), these are useful for healing injured tissue by creating new blood vessels, a critical part of the healing process.

Adipose Tissue-Derived Stem Cells Inhibit Neointimal Formation in a Paracrine Fashion in Rat Femoral Artery

Fat tissue is becoming increasingly recognized as a major contributor to the biochemical balance in the body. For example, during times of obesity, fat tissue produces compounds such as leptin that suppress, or attempt to suppress appetite. Fat tissue contains numerous cell types that control inflammation such as T regulatory cells, and alternatively activated macrophages (Riordan et al. Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis. J Transl Med. 2009 Apr 24;7:29). Additionally, fat tissue contains several populations of stem cells, including mesenchymal stem cells, and hematopoietic stem cells.

In the study published today, fat mesenchymal stem cells were isolated from rats and tested for ability to promote healing of the endothelium, which is the lining of the blood vessels. The endothelium is very important because damaged endothelium is believed to be the cause of atherosclerosis.

The first set of experiments that the scientists performed was to try to “differentiate” or transform the fat mesenchymal stem cells into endothelial cells in the test tube. Treatment of the stem cells with an optimized mix of chemicals, called “endothelial growth media” resulted in cells that resembled endothelium based on expression of proteins on the cell surface. Specifically, the “home grown” endothelial cells expressed the markers Flt-1 and responded to SDF-1, a protein known to attract endothelial cells.

In order to mimic the condition of atherosclerosis development, a wire was inserted into the femoral artery and used to “scratch” the endothelial surface so as to produce an injury. In animals that did not receive stem cells, the injury resulted in a lesion that resembled the atherosclerotic plaque. When stem cells that were differentiated into endothelial cells were administered in the injured area, the lesion size was reduced, or in some animals completely absent.

Most interesting in the study was that the differentiated endothelial cells did not incorporate themselves into the existing blood vessel endothelium. Specifically, the injected cells could have been injected even outside of the endothelium and prevention of injury would be seen. These data suggest that the endothelial cells generated in vitro seem to work by producing therapeutic factors that accelerate healing, but not necessarily by replacing the function of the old endothelium. One interesting next step of this research may be to purify the growth factors made, and administer them instead of stem cells as a therapeutic approach to prevention of atherosclerosis.

Stem Cell Therapeutics Corp. Announces Private Placement

Stem Cell Therapeutics is a biotechnology company from Calgary Canada that is developing a novel type of stem cell therapy: instead of administering stem cells, they give drugs that activate the patient’s own stem cells. The company licensed intellectual property from Dr. Samuel Wise, which covered the use of agents such as erythropoietin, human chorionic gonadotropin (hCG), parathyroid hormone, and prolactin, for stimulation of the body’s own stem cells.

The company published a paper describing their Phase I clinical trial of hCG entitled "Open labeled, uncontrolled pharmacokinetic study of single intramuscular hCG dose in healthy male volunteers" the August 2009 issue of the International Journal of Clinical Pharmacology and Therapeutics. Which assessed feasibility of administration of hCG and demonstrated it can cross the blood brain barrier by assessment of cerebral spinal fluid levels of the hormone. These data were important because it allowed the company to enter Phase II clinical trials for treatment of stroke using a combination of the red blood cell stimulating hormone erythropoietin, together with hCG.
If successful, this will be one of the very few companies that uses injectable drugs as a substitute for stem cells. This is an important paradigm shift in cell therapy since many of the current therapies require manipulation of cells outside of the body, which is expensive and currently limited to a small number of clinical trials.

The company is also working on other neurological conditions including multiple sclerosis and traumatic brain injury, both of which are in preclinical stages of development, however animal data to date has been promising. For multiple sclerosis the hormone prolactin is being used as a stem cell stimulatory drug, whereas for brain injury hCG and erythropoietin are used, in a similar model as in the current stroke trials.

Today Stem Cell Therapeutics announced that it has closed on two separate financing deals that together yielded $2,186,941 in gross proceeds. The first deal was a brokered private placement through J.F. Mackie & Company Ltd for $1,138,741, whereas the second was a non-brokered offering of $1,048,200. The company reported that proceeds will be used for general working capital purposes.

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.

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.

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.