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).

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."

Mike George, a retired junior high school principal, had been suffering from an advanced case of systemic scleroderma. Translated literally as "hard skin", scleroderma is a chronic autoimmune disease characterized by fibrosis (tightening and hardening of tissue) and for which conventional medicine has no known cure. Of the two main versions of the disease, the systemic version (also known as diffuse cutaneous scleroderma) involves internal organs as well as the skin. In the version of the disease known as limited cutaneous scleroderma, symptoms are limited primarily to the skin, although secondary complications may manifest in the pulmonary system. Vascular complications are not uncommon in the systemic version, and when one or more internal organs are affected, the disease can be fatal.

Fourteen months ago, however, Mr. George underwent autologous adult stem cell therapy as part of a clinical trial at Northwestern Memorial Hospital in Chicago. Now, according to Mr. George, "I feel really good. I feel I was reborn. It’s great to be alive."

Prior to the therapy last year, Mr. George’s skin was stiff, his face was tight, he could only swallow with difficulty, any type of physical movement was an effort, and his doctors were concerned that the disease had begun spreading to his heart and lungs. Upon his return back home after the therapy, however, Mr. George was able to lift his luggage out of the trunk of his taxi – an accomplishment which had not been possible prior to the stem cell therapy. The next month, as Mr. George describes, his physician didn’t recognize him. "In April, the doctor said, are you sure I didn’t give you a lung transplant, instead of a stem cell transplant?" Although the stem cell therapy has not totally cured Mr. George, it has stopped the progression of the disease and to some extent reversed it, with noticeable improvement not only in his skin but also in his heart and lungs as well.

On May 17, 2005, it was announced that Northwestern Memorial Hospital and the Northwestern University Feinberg School of Medicine in Chicago together launched the Northwestern Scleroderma Program, which offers patients with scleroderma a unique program of comprehensive care. According to Dr. John Varga, a rheumatologist and director of the Northwestern Scleroderma Program, "Patients who are diagnosed with scleroderma are often told that there is little that can be done for them. At Northwestern, our integrated team of experts specializes in the treatment of scleroderma and all of its related conditions. We can offer patients treatment options they can’t find elsewhere, like bone marrow transplants, while also giving them access to other important disease management services such as physical and rehabilitative therapy and nutritional counseling and support." As described on their website, "The Northwestern Scleroderma Program offers the latest advances in diagnostics and treatment for scleroderma, including bronchoscopy and lavage, high-resolution CT scanning, right heart hemodynamics (blood circulation), advanced esophageal studies, innovative treatments for pulmonary hypertension and scleroderma lung disease, as well as autologous stem cell therapies."

In fact, on this website we have previously reported a number of times in the past on various clinical studies conducted at Northwestern Memorial Hospital in which patients have shown dramatic success after having received autologous adult stem cell therapy, usually for the treatment of other types of autoimmune diseases such as multiple sclerosis. In particular, Richard Burt, M.D., Chief of the Division of Immunotherapy for Autoimmune Diseases at Northwestern Memorial Hospital, is gaining increasing attention for his pioneering use of hematopoietic stem cells in the treatment of various autoimmune diseases which include not only multiple sclerosis but also rhematoid arthritis, lupus, and Chron’s disease, among others. In 2006 Dr. Burt was named within The Scientific American 50, which is the magazine’s annual list of outstanding leaders in science and technology. According to John Rennie, editor-in-chief of the magazine, "The Scientific American 50 pays tribute to individuals and organizations who, through their efforts in research, business and policy-making, are driving advances in science and technology that lay the groundwork for a better future. Not only does our list honor these prime movers, it shines a spotlight on the critical fields that are benefiting from their achievements." Continuing his distinguished and pioneering use of autologous adult stem cell therapy, Dr. Burt is currently involved in ongoing randomized clinical trials for a number of autoimmune diseases which include systemic scleroderma.

Usually, in clinical trials, patients are neither charged nor remunerated for their participation in the trial. However, even though the scleroderma clinical trials at Northwestern are FDA-approved and tightly controlled, nevertheless Mr. George had to pay for the medical services that he received as a participant in the study, which came to more than $200,000. Family members, friends, and the communities at his church and school district helped contribute to the cost of his medical expenses.

In the study, the autologous adult stem cells were harvested from Mr. George’s own bone marrow and then readministered to him therapeutically after having been isolated, purified and expanded in the laboratory. First, however, he also received a heavy dose of chemotherapy, the purpose of which was to "cleanse" his immune system before he received his own adult stem cells, which not only served as a therapy for his scleroderma but also "rescued" his immune system from deliberate destruction by the chemotherapy. The use of chemotherapy prior to autologous adult stem cell therapy is, unfortunately, not uncommon. Fortunately, however, the scientific logic of such a routine practice is becoming increasingly questioned.

In actuality, other doctors have already demonstrated success in treating various autoimmune diseases with adult stem cell therapy, but without the brutal and deliberate destruction of the immune system with chemotherapy. Known as immunological myeloablation, such a procedure had previously been considered a necessary part of any transplant therapy, even though it exposes the patient to potentially life-threatening risks. Today, however, an increasing number of doctors are questioning the logic and necessity of subjecting their patients to deliberate immune destruction, and with valid scientific reason. In a publication that appeared over two years ago, in the Journal of Translational Medicine in January of 2007, Dr. Neil H. Riordan et al. posed the following question: "…in patients who are not suffering from a disease that is associated with an aberrant bone marrow such as hematological malignancies or immunological dysfunctions, how is it justifiable to subject them to the high levels of morbidity and mortality associated with immune suppression?" Dr. Riordan and his team of scientists then examined compelling evidence which strongly indicates that pre-transplant immune suppression is unnecessary for autologous hematopoietic cell therapies and even for some types of allogeneic therapies, such as those that utilize "universal donor" cells such as mesenchymal stem cells and the CD34+ stem cells that are found in umbilical cord blood, and for which immune rejection is not even a concern. As Dr. Riordan and his colleagues wrote in their 2007 paper in a section that is subtitled, "Mesenchymal stem cells do not need myeloablation for efficacy": "Currently there are several ongoing clinical trials in Phase I-III using ‘universal donor’ mesenchymal stem cells in non-conditioned recipients of Crohn’s disease, GVHD (graft-versus-host disease) and myocardial infarction. Although these cells are bone marrow expanded mesenchymal cells, the superior proliferative potential of cord blood mesenchymal cells may allow them not only to escape immune destruction, but also to expand in vivo and mediate therapeutic effects superior to those derived from bone marrow. The fact that regulatory agencies have allowed advancement of ‘off-the-shelf’ universal donor mesenchymal stem cells supports the numerous reports of clinical efficacy in an allogeneic setting." Therefore, certainly with autologous (in which the donor and recipient are the same person) adult stem cell therapy, there is no risk of immune rejection so there is no need to destroy the immune system with chemotherapy; but even with many types of allogeneic (in which the donor and recipient are not the same person) adult stem cell therapy, such as with "immune privileged" "universal donor" stem cells, there is also no need to destroy the immune system with chemotherapy.

Nevertheless, for clinical trials such as those conducted at Northwestern University, the autologous adult stem cell therapies offer tangible improvement – at least for those patients who survive the life-threatening destruction of their immune systems from the chemotherapy. One can only conclude, therefore, as has already been demonstrated by other doctors at other clinics, that patients would exhibit even greater and faster improvement if they did not have to recover from the deliberate destruction of their immune systems prior to receiving the stem cell therapy. Additionally, other clinical evidence indicates that even greater patient improvement would be seen if the stem cell therapy would utilize the "superior proliferative potential" of the adult stem cells that are found in umbilical cord blood.

It has been estimated that between 150,000 and 300,000 people in the U.S. alone suffer from scleroderma. Having been one of the fortunate patients who was strong enough to survive the deliberate and unncessary destruction of his immune system prior to receiving his autologous adult stem cell therapy, Mr. George is now a devout believer in autologous adult stem cells. "I’m like an advocate," he says. "All my life, I wanted to help people. Helping kids was my forte. Now to help someone in need who doesn’t know what to expect, it raises it to a whole different level."

As previously reported on this website a number of times, rapid progress has been made over the past few years in veterinary medicine using autologous adult stem cells. Now, the consistent success of such therapy is finally getting the attention of the human medical community, which is beginning to replicate the veterinary procedures in human clinical trials.

Autologous (in which the donor and recipient are the same individual, whether a person or a dog or a horse) adult stem cell therapy has been routinely used in recent years for the treatment of a variety of conditions in large domesticated animals. Such conditions most commonly include orthopedic injuries in competitive horses, while in dogs the most commonly treated condition is age-related degenerative osteoarthritis. Although such stem cell therapies could also be of benefit to smaller animals such as cats, orthopedic injuries are not usually life-threatening to these smaller animals whereas such an injury could be fatal for a thoroughbred race horse. Consequently, veterinary stem cell therapy has been applied very aggressively to these valuable, expensive, large animals whose lives and competitive 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.

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.

According to Dr. Sean Owens, veterinarian and founding director of the Regenerative Medicine Laboratory at UC-Davis, "Soft-tissue injury is the number-one injury competitive horses will suffer, and it can end a thoroughbred horse’s career." Additionally, Dr. Owens adds, "Regulatory oversight of veterinary medicine is minimal. For the most part, the USDA (U.S. Department of Agriculture) and the FDA (Food and Drug Administration) have not waded into the regulatory arena for us." Precisely because of such a lack of federal government regulation in the veterinary industry, this newly created research center which Dr. Owens has established is able to dedicate itself to the advancement of animal stem cell medicine, which in turn should translate into the advancement of human stem cell medicine through parallel clinical trials. A number of ongoing clinical trials in horses are conducted at the Laboratory, which include those for tendon tears and those for fractured bone chips in the knee – and now a similar type of autologous adult stem cell therapy for these same conditions will be developed for human clinical trials. Ultimately, such a program will result not only in the development of better treatments for horses, but also in the development of better treatments for humans. Currently Dr. Owens is collaborating with Dr. Jan Nolta, director of the Stem Cell Program at UC-Davis, who has been appointed to oversee the human trials. As Dr. Owens explains, "Part of our mission is to do basic science and clinical trials and also improve ways of processing cells."

Similarly, VetCell of the U.K. initially chose to focus specifically on tendon injuries in horses precisely because these injuries bear such a close resemblance to the same injuries in humans, and therefore the medical procedures should be easily translatable from veterinary to human medicine. In fact, while damage to a rotator cuff or an Achilles tendon would certainly be extremely painful in a human, it probably would not be fatal, whereas such injuries in a horse could prove fatal. The veterinary procedures have therefore had to advance very carefully and meticulously – despite the absence of a controlling government regulatory system – merely because of the severe and extreme nature of such animal injuries. Next year, VetCell plans to begin autologous adult stem cell therapy for human patients with Achilles tendon damage, which will mark VetCell’s first human clinical trials in which an equine procedure will be translated to a human procedure. As with the horses, the human autologous adult stem cells will be derived from each human patient’s own bone marrow, from which the stem cells will then be isolated, purified, expanded and readministered to the patient therapeutically, usually by injection directly into the area of tissue damage. According to Dr. Mountford, "Our long-term goal is to use it to treat a number of tendon injuries."

Likewise, Vet-Stem of California has already demonstrated success in a double-blind, placebo-controlled clinical trial with autologous adult stem cells in the treatment of arthritic dogs. As Dr. Robert Harman, veterinarian and founding CEO of the company, points out, "About 200,000 hip replacements are done every year in humans. That’s a very good target for someone to look at cell therapy." 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 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.

Vet-Stem was founded in 2002 as the result of stem cell research conducted at the University of Pittsburgh and UCLA in the late 1990s, when Dr. Bob Harman saw the commercial potential for veterinary applications of such stem cell technology. A veterinarian himself, as well as a statistician and former biotech entrepreneur who had already held the top executive title at 3 biotechnology companies prior to Vet-Stem, Dr. Harman is now the CEO of Vet-Stem as well as one of its founders. Based in San Diego, Vet-Stem patterned its initial clinical model upon the example of other companies that were already involved in human adult stem cell therapies, such as Cytori Therapeutics which had developed a proprietary separation apparatus that harvests human adult stem cells from adipose tissue at the patient’s bedside during reconstructive or cosmetic surgery. In a similar procedure, veterinarians extract approximately 2 to 3 tablespoons of adipose tissue from each animal, which are then sent to Vet-Stem’s laboratories where the adult stem cells are isolated, purified, expanded and returned within 48 hours to the veterinarian who then administers the stem cells to the animal. The procedure has demonstrated a consistently high success rate and its use is becoming increasingly widespread not only for horses but also for dogs. Among other partnerships, in September of 2007 Vet-Stem licensed their proprietary adult stem cell technology to the Central Veterinary Research Laboratory (CVRL) of Dubai in the United Arab Emirates, thereby allowing the CVRL to offer the same adipose-derived adult stem cell animal therapies throughout the Middle East. Sheik Mohammed bin Rashid al-Maktoum, the ruler of Dubai and the Prime Minister of the UAE, is an avid thoroughbred owner and a sponsor of the Dubai World Cup, the world’s most highly-prized horse race. As Dr. Harman described in 2007, "The Central Veterinary Research Laboratory will be an excellent partner in bringing this technology from the U.S. to the Middle East as they are already the most respected reference lab in the region." CVRL now provides stem cell services for the treatment of injuries not only in thoroughbred race horses and Arabian endurance horses, but also in racing camels, among other species, throughout the Middle East. As already mentioned, to date Vet-Stem has treated over 3,000 horses and over 2,000 dogs with joint injuries and degenerative conditions that include tendon and ligament injuries as well as age-related osteoarthritis. Vet-Stem’s overall success rate is around 80% in the number of animals who are able to return to normal performance, a rate that is significantly above that of conventional surgical and pharmaceutical therapies.

VetCell Bioscience developed the equine autologous adult stem cell procedure in the U.K., where such therapy is now routine practice at most equine veterinary locations and is even covered by most equine insurance policies. VetCell uses mesenchymal stem cells (MSCs) that are derived from the animal’s own bone marrow which is extracted from the horse’s sternum, from which the MSCs are then isolated, expanded to more than 10 million cells, re-suspended in bone marrow supernatant which is rich in growth factors and other chemical nutrients, and then the cells are injected directly into the site of the injury where the cells regenerate the tendon tissue and also prevent the formation of scar tissue, which is often a main hindrance to healing and the cause of future reinjury. Physical rehabilitation and a controlled exercise program are also important to the recovery of the horse, and periodic MRI (magnetic resonance imaging) scans are taken to monitor the healing. VetCell Bioscience specializes in the development and commercialization of new biotechnologies for veterinarian musculoskeletal regeneration. VetCell was formed in partnership with the Royal Veterinary College and the Institute for Orthopaedic and Musculoskeletal Science, and is a trading company within MedCell Bioscience, its parent company, which develops musculoskeletal regenerative therapeutics for human clinical treatment. As stated on their website, "VetCell has rapidly commercialised a technique for the multiplication of equine stem cells which can be used in the treatment of tendon and ligament injury. This service is now available to veterinary surgeons in the U.K. and internationally. VetCell has also developed a simple method for separating and storing stem cells from the umbilical cords of foals." Although VetCell specializes in the treatment of horse injuries, they are also expanding their services and products to therapeutic applications for dogs, cats and other domestic species, in addition to their human clinical trials which will commence next year. Headquartered in Cambridge, England with laboratories in Edinburgh, Scotland, MedCell and VetCell also have offices in Germany, Spain, China, Australia, South America, Canada and the United States.

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 both procedures are mesenchymal stem cells (MSCs), which are highly potent adult stem cells that are found not only in bone marrow and adipose tissue but also umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of MSCs.

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.

Diagnosed in 2005 with multiple sclerosis, Sam Herrell had few options available to him in the U.S., his home country. Now, however, he is traveling to Central America in order to receive an adult stem cell therapy that was pioneered by American doctors but which is not yet available within the United States.

A proud native of Texas, the Ennis Lions football coach has decided to travel to ICM – the Institute for Cellular Medicine – in Central America for treatment with his own adult stem cells. The ICM has an 80% success rate with its patients, but don’t expect the treatment to be available any time soon within the U.S., since the U.S. FDA (Food and Drug Administration) has made such a procedure legally impossible for doctors to conduct within the United States. Specifically, the FDA has decreed that autologous (in which the donor and recipient are the same person) adult stem cells must be classified and regulated as a "drug", and therefore cannot be used as a clinical therapy until first being subjected to the ordinary FDA laws that govern pharmaceutically manufactured drugs, which is a process that typically requires a decade or more of testing before approval can be obtained. Most patients, with multiple sclerosis as well as other diseases or injuries, cannot wait a decade or longer for treatment, so they are following the U.S. doctors who have set up their clinics outside of U.S. borders. If the FDA would only change their stance on this critically important issue, then the U.S. doctors who pioneered this adult stem cell treatment would be able to administer the therapy within the U.S., and then perhaps there wouldn’t be such an endless debate over embryonic stem cells, which still have years if not decades left before they could be considered for use in clinical therapies. Unlike embryonic stem cells, adult stem cells are already being used in clinics around the world to treat real people with real diseases – but not within the U.S., except for the very limited number of FDA-approved clinical trials that are being conducted.

As Sam Herrell explains, "The thing that’s kind of disappointing is that the neurologists here have nothing that really gives you much hope. All they can do is say keep on this medication and hope it slows down, hope it doesn’t overtake your whole nervous sytsem before they find a cure. Outside the U.S., some things are being done that people have had phenomenal results with, and that’s been encouraging. I really think there’s going to be a cure for it – that’s what I’m hoping for. It’s been encouraging to hear those stories and talk with people."

A number of scientific studies in the medical literature support such claims, not the least of which is an article that was published in the Journal of Translational Medicine in April of 2009, entitled, "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., in which scientists and doctors elucidate the various cellular and molecular mechanisms that are at work when this type of autologous adult stem cell therapy is implemented as a treatment for multiple sclerosis. Additionally, 3 case studies are described in the paper in which patients with multiple sclerosis showed significant improvement after receiving such a treatment. Of particular significance are the unique immunomodulatory properties of this therapy, which play an especially vital role in a disorder of autoimmune origin such as multiple sclerosis.

In specific reference to ICM, Mr. Herrell adds, "I’ve heard of two different procedures I really think I’ll try. It’s very expensive, but that’s a hurdle I can try to tackle for hope of a cure. I get excited when I talk to those people who have gone outside the country, because they’ve come back with a story of hope. I’m still hopeful for a cure. I’m serious about that. These people who have tried some of these things, they don’t feel better, they feel cured. That’s what I’m hoping for. Then I can still live in Texas."

However, the U.S. FDA still insists that the cells within a person’s own body are "drugs" and therefore cannot be administered, not even to that very same person, for therapeutic purposes until first being subjected to the exact same multi-year, multi-million dollar approval process by which the pharmaceutical industry is regulated. Unless the FDA ever changes its position on this issue, people such as Sam Herrell will be forced to travel outside of the U.S. in order to be treated with their own, autologous adult stem cells.

Fortunately, at least such therapy does exist somewhere in the world, even though not in the United States.

In order to treat her multiple sclerosis, Ann Lacy is traveling to a clinic in Central America for adult stem cell therapy. Currently she is in the process of raising approximately $35,000 for her trip, which will cover not only the cost of the therapy itself but also related travel expenses. The therapy is not eligible for insurance coverage, even though this particular clinic, the Institute for Cellular Medicine (ICM), boasts an 80% success rate in treating its patients.

The reporter for this particular news report as it appeared in the Tri County Leader states that, "The treatment has not been approved by the U.S. Food and Drug Administration, and studies on the effectiveness of this therapy are virtually nonexistent."

In fact, while the first half of that sentence is true, the second half is not. Numerous studies have already been reported in the medical literature which do, indeed, document both the safety and the efficacy of this therapy, such as, for example, the article entitled, "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., which was published in the Journal of Translational Medicine on April 24, 2009 and which meticulously documents 3 clinical case reports of multiple sclerosis patients who were treated with this type of autologous adult stem cell therapy and who subsequently showed dramatic improvement. Additionally, numerous other reports in the conventional, peer-reviewed medical literature also exist on the topic of adult stem cells, especially mesenchymal stem cells, as a treatment for multiple sclerosis, which any simple search of the medical literature would immediately reveal. To say that "studies on the effectiveness of this therapy are virtually nonexistent" is merely to advertise one’s ignorance of the topic, since such a statement is egregiously false.

The first half of the sentence, unfortunately, is very true: namely, such therapies have not been approved by the U.S. Food and Drug Administration. The FDA approval process is notoriously a very lengthy and expensive one, typically lasting a decade or longer and costing millions of dollars, even under the best of circumstances. In this particular instance, however, the prospect of ever getting autologous (in which the donor and recipient are the same person) adult stem cell therapy approved by the FDA is further complicated by the fact that the FDA has specifically outlawed such a procedure in the United States. In other words, the FDA has decreed that each person’s own endogenous, naturally occurring adult stem cells are "drugs" and therefore must be regulated as such, and therefore cannot be clinically administered as therapies in the U.S. – not even to the same person from whom the cells were obtained – until having first been subjected to the multi-year, multi-million dollar federal governmental approval process. It is this stance by the FDA on autologous adult stem cells – not any restrictions on the federal funding of embryonic stem cell research – which is the primary obstacle to stem cell therapies in the United States. Human embryonic stem cell (hESC) research has continued in previous years with private funding, yet hESCs still have at least another decade to go before they can be considered safe enough for clinical use, according to expert consensus among the hESC scientific community. Meanwhile, adult stem cell therapies are already in use throughout the world, in almost every country except the U.S., because of this ruling by the U.S. FDA. Only in the U.S. are a person’s own tissues and cells considered to be "drugs".

A number of grass-roots organizations have been formed in response to the FDA’s stance, which include the physician-based American Stem Cell Therapy Association (ASCTA) and the patient-based "Safe Stem Cells Now!". More information on these organizations is available at their websites, www.stemcelldocs.org and www.safestemcells.org, respectively.

As Dr. Christopher Centeno, founding CEO of the adult stem cell company Regenerative Sciences, and one of the founders of the ASCTA, has stated, "While the Obama administration seems to have opened the embryonic stem cell door, their FDA seems to want to slam the adult stem cell door shut."

(Please see the related news articles on this website, entitled, "Arizona Man Travels to Central America for Adult Stem Cell Therapy", dated July 16, 2009; "Bangor Family Heads to Central America for Adult Stem Cell Therapy", dated July 8, 2009; and "Two U.S. Adult Stem Cell Companies Form Collaboration in Asia", dated May 11, 2009).

Judy DiCorcia of New York has written an open letter to President Obama in which she describes the improvement of her 10-year-old autistic daughter, Lauren, after adult stem cell therapy was administered to the child at the XCell-Center in Cologne, Germany.

The treatment, which cost approximately $10,000, took place in January of this year and consisted of a simple procedure in which adult stem cells were extracted from the girl’s own bone marrow and then readministered via a lumbar puncture in the girl’s spine. The technique was quick, simple and minimally invasive.

According to the girl’s mother, Lauren has shown significant improvement in a number of ways, including being able to sleep through the night for the first time in the girl’s life. Not quite half a year after the treatment, Ms. DiCorcia now reports that "Lauren is doing well. I would have to say that she plateaued at about the 12-week mark. Her situation is stable and fortunately all positive effects have persisted. I wish the doctor could fly to the U.S. and perform the therapy here!"

The XCell-Center is a private clinical group and institute for regenerative medicine which operates two treatment centers, one in Cologne and one in Dusseldorf, Germany. It is the first privately owned medical center in Europe to specialize in regenerative medicine. In addition to providing autologous adult stem cell therapies to patients, the XCell-Center is also actively involved in pre-clinical and clinical research. Since January of 2007, more than 1,600 patients have been treated with their own adult stem cells at the XCell-Center.

As stated on their website, the XCell-Center "is the first private institute worldwide to hold an official license for the extraction and approval of stem cell material for autologous treatment." Since only adult stem cells are used at the XCell-Center, not embryonic stem cells, the treatments are ethically noncontroversial and scientifically proven to be medically safe. Since only autologous (in which the donor and recipient are the same person) adult stem cells are used, there is no risk of immune rejection. The XCell-Center operates in full accordance with German law and European guidelines. The specialized team of physicians at the XCell-Center includes neurosurgeons, cardiologists, hematologists, orthopedists, radiologists and pharmacologists. In addition to autism, the XCell-Center also treats a number of other medical conditions which include stroke, cerebral palsy, spinal cord injuries, orthopedic injuries, ischemic heart disease, peripheral artery disease, diabetes and complications thereof, multiple sclerosis, Alzheimer’s disease, Parkinson’s disease and other degenerative illnesses.

The XCell-Center boasts an international advisory board and is a member of the German Society for Regenerative Medicine. Its headquarters are located at the Dominikus hospital in Dusseldorf, while its second branch is located at the Eduardus Hospital’s Institute of Regenerative Medicine in Cologne.

As explicitly stated on the website of the XCell-Center, "therapy with embryonic stem cells is strictly prohibited in Germany. At the XCell-Center, we only use the patient’s own stem cells for therapy." The strict prohibition of embryonic stem cell therapy in Germany, as in many other countries, is based not so much on ethical concerns but on concrete scientific reasons, not the least of which is the fact that embryonic stem cells are medically unsafe. In addition to causing teratomas (a specific type of tumor), embryonic stem cells are notorious for their numerous other inherent problems which disqualify them for any type of clinical therapeutic use.

Back in the U.S., Lauren’s mother, Ms. DiCorcia, wishes that this type of adult stem cell therapy were available in the U.S., so that she wouldn’t have to travel to Germany for her child’s treatment. Unfortunately, however, adult stem cell therapies, such as these that are being used with such success in Germany, which already exist and which are already being used in clinics around the world, would be available in the U.S. were it not for the fact that the FDA (Food and Drug Administration) has outlawed such therapies by designating each person’s own adult stem cells as a "drug" which therefore must be regulated by the same laws that apply to the giant pharmaceutical companies that manufacture prescription medication. Consequently, it is this stance by the FDA which is forcing all adult stem cell physicians to relocate outside of the U.S., where they set up their clinics in any and every other country on earth except the United States.

Ms. DiCorcia’s open letter to the President of the United States is reproduced herein:

"Dear President Obama,

I am the mother of a 10-year-old autistic daughter. In January, we took Lauren to Cologne, Germany for adult stem cell therapy. The center used her own stem cells drawn from her hip bone marrow, centrifuged the next day, and then reinserted via lumbar puncture the following day (2.95 million cells). Both procedures were quick and not invasive at all. In the past 6 weeks we have seen significant improvements in our daughter’s behaviors, focus, hyperactivity, and insomnia. I would rate a general improvement of about 40% – this is HUGE for a family living with autism. Our daughter started sleeping through the night for the first time (yes, she is 10 and got up every night) since stem cells. Lauren is happier just in her own skin – so much less frustrated and just generally happier. She is getting through her one-on-one therapy more quickly, better focused, and more compliant. Of course, it amazes me that this simple, non-controversial therapy cannot be done here in the United States.

Sincerely,

Judy DiCorcia"

The biotech company Pluristem Therapeutics, formerly known as Pluristem Life Systems, has been granted patent # 7,534,609 for a method of expanding undifferentiated hemopoietic stem cells.

Pluristem Therapeutics specializes in the development and commercialization of allogeneic (in which the donor and the recipient are not the same person) cellular therapy products derived from the human placenta for the treatment of severe ischemic autoimmune disorders such as multiple sclerosis, peripheral artery disease, ischemic stroke, inflammatory bowel disease including Crohn’s disease, and others. The company’s proprietary technology includes a 3D bioreactor, PluriX, which simulates the microenvironment of bone marrow substrates for the large-scale culturing and three-dimensional expansion of stromal cells without the need for supplemental growth factors or other exogenous materials. The cells generated by PluriX, known as "PLX" (PLacental eXpanded) cells, not only possess "immune privileged" properties but also immunomodulatory properties as well, and are expandable in vitro without exhibiting phenotypic or karyotypic changes. This new patent, however, was awarded to Pluristem for an invention involving methods and materials by which undifferentiated hemopoietic stem cells may be expanded in a novel type of bioreactor which is separate and distinct from the PluriX.

Pluristem Therapeutics is focused on the development and commercialization of off-the-shelf allogeneic cell-based therapies for the treatment of chronic degenerative ischemic and autoimmune disorders. As described on their website, Pluristem specializes in adherent stromal cells (ASCs) that are derived from the human placenta and which "are multipotent adult stem cells that have strong anti-inflammatory properties and can regenerate and repair damaged tissue." ASCs have already been shown to differentiate into nerve, bone, muscle, fat, tendon, ligament, cartilage and bone marrow stroma. Additionally, since they have low immunogenicity, ASCs do not require HLA (human leukocyte antigen) matching and are not at risk of being rejected by the patient’s immune system. After the ASCs are harvested from placental tissue, the cells are then expanded three-dimensionally into the PLX cells via the company’s proprietary PluriX 3D bioreactor, in which the cells are able to excrete their own cytokines and other immune modulators without the need for risky supplemental growth factors nor other exogenous materials. As adult stem cells that are derived from the human placenta, which is an extremely rich source of non-embryonic stem cells, ASCs are also ethically non-controversial in addition to being highly potent adult stem cells.

As stated on Pluristem’s website, "The Company has made a strategic decision to work only with adult stem cells since the practical use of embryonic stem cells is severely restricted by various religious, ethical and legal considerations."

In a manner which is similar to that by which the PluriX bioreactor three-dimensionally expands ASCs into PLX cells, the new invention allows undifferentiated hemopoietic cells to be expanded three-dimensionally upon stromal feeder cells, without undergoing differentiation. At least theoretically, such a bioreactor could be adapted to any type of cell, and a reviewer of the patent in StemCellPatents.com suggested the applicability of the bioreactor to the expansion of embryonic and iPS cells.

In separate though related news stories, earlier this year Pluristem received approval to begin clinical trials for the treatment of critical limb ischemia with its proprietary adult stem cell product PLX-PAD, an allogeneic placental-derived stromal cell product. In May of 2009, Pluristem also announced the selection of a major clinical site in North Carolina for the PLX-PAD Phase I clinical trial, which will be conducted at Duke University Medical Center. According to Zami Aberman, president and CEO of Pluristem, "We are very pleased to be working with Duke University Medical Center on the Phase I clinical trial using our PLX cells and believe that being involved with such a prestigious, reputable institution emphasizes the important therapeutic future for our mesenchymal-like stem cells."

According to Duke University cardiologist Dr. Robert Mitchell, the principal investigator for the PLX-PAD trial, "We look forward to collaborating with Pluristem in studying this interesting potential approach to dealing with limb ischemia. This is an oftentimes devastating disease and beginning the process of understanding the action of these cells in a Phase I clinical trial is an important step forward."

In the U.S. alone, it has been estimated that as many as 12 million people suffer from critical limb ischemia (CLI), an advanced form of peripheral artery disease (PAD) that is associated with high rates of morbidity and mortality, often resulting in amputation and frequent hospitalization. Although standard medical therapies are currently ineffective in treating CLI, the market value for an effective CLI therapy has been projected to be over $1 billion. For the first time, cell-based therapies such as Pluristem’s PLX-PAD offer a potentially safe and effective treatment of a life-threatening medical condition which previously has been incurable.

In addition to its cell-based therapy for CLI, Pluristem is currently developing other adult stem cell products for the treatment of other degenerative, malignant and autoimmune disorders. The company’s first product, PLX-BMT, was directed at improving the engraftment of hematopoietic stem cells derived from umbilical cord blood as an alternative to bone marrow transplantation.

Although the company’s most recent patent, for a method of expanding undifferentiated hemopoietic stem cells, was awarded on May 19, 2009, the patent application was originally filed on April 11, 2005, at which time the company was known as Pluristem Life Systems. On November 26 of 2007, however, corresponding to a reverse stock split and the designation of a new ticker symbol, the company also announced the official change of its name to Pluristem Therapeutics.

(Please see the related news article on this website, entitled, "Pluristem to Begin Adult Stem Cell Clinical Trials for Critical Limb Ischemia", dated January 13, 2009).

Acute vascular rejection (AVR) remains a serious complication of heart transplantation. When the immune suppressant cyclosporin A is administered to recipients in the C3H-to-BALB/c heterotopic cardiac transplant model, however, survival of the grafts has been extended to as long as 15 days, which is nearly twice as long as graft survival time in untreated patients. Now, Canadian researchers have demonstrated a method for preventing AVR altogether.

Led by Dr. Hao Wang of the London Health Sciences Centre in Ontario, Canada, the scientists used a bone graft from a third-party donor, in addition to cyclosporin A, for immune modulation of the antibody-mediated AVR. The results indicated indefinite allograft survival, for more than 100 days, without any signs of AVR.

The stem cells from the bone marrow were found to stimulate the generation of T regulatory cells as well as dendritic cells, which also resulted in radioresistance. By contrast, bone marrow mononuclear cells did not improve survival.

As the authors conclude, "Due to the fact that current immunosuppressive approaches are clinically ineffective at preventing AVR, this study provides promise for further investigations of BM (bone marrow) components as a means of addressing a currently unmet medical need."

Two of the authors of this study were also involved in a previous study published in April of this year in which adult stem cells derived from adipose (fat) tissue were found to exhibit immune modulation in three patients with multiple sclerosis.

While adult stem cells are most widely known for their ability to regenerate damaged tissue, their immunomodulatory properties also hold great therapeutic promise for a number of currently untreatable conditions.

(Please see the related news article on this website, entitled, "Adult Stem Cells From Fat Help Multiple Sclerosis Patients", dated April 24, 2009, as originally reported in the Journal of Translational Medicine).

Once again, the pharmaceutical giant Pfizer has entered into a collaborative agreement with academia, this time licensing human embryonic stem cell patents from the University of Wisconsin at Madison. The patent technology will be developed not for clinical cell-based therapies, per se, but primarily for the testing of new drugs. Terms of the arrangement were made with the Wisconsin Alumni Research Foundation (WARF), the university’s licensing arm.

According to Ruth McKernan, chief scientific officer of Pfizer Regenerative Medicine, "Our license with WARF provides us with information and materials that will allow us to use their cell lines to explore a whole new range of therapies. Stem cells can be used to create specialized human tissue. Our scientists will determine how new medicines may be able to improve the way stem cells regenerate damaged tissues. We will be optimizing the production of cells that could, one day, be used for therapeutic purposes."

According to Wisconsin Governor Jim Doyle, "To have these two giants in the field of biopharmaceutical research and stem cell research come together brings us one step closer towards finding relief from diseases like diabetes, Alzheimer’s, Parkinson’s, multiple sclerosis and cancer."

Of course, the entire field of embryonic stem cell research was born at the University of Wisconsin at Madison, where Dr. James Thomson became the first person ever to isolate a stem cell in the laboratory, first from a nonhuman primate in 1995 and later from a human in 1998. By "these two giants", therefore, Governor Doyle is referring of course to Pfizer and also to the entire "industry" of stem cell scientists and laboratories that has sprung up around Dr. Thomson over the past decade.

Actually, as Dr. Thomson himself has stated on a number of occasions, he does not expect embryonic stem cells to yield cell-based therapies for diseases in the immediate future, but instead he expects embryonic stem cells to be most useful as a way of testing new pharmaceuticals, which in the past could only be tested in animal models since human tissue was not available. In fact, in November of last year, Dr. Thomson formed a new company, Cellular Dynamics International (CDI), precisely for this reason. Focused specifically on the commercialization of stem cell technology as it applies to drug testing and research, rather than to the discovery of cell-based therapies per se, CDI is centered around the development of new technology which can supply human heart cells to researchers for use in drug testing, especially for the testing of adverse reactions to pharmaceuticals. (Please see the related news article on this website entitled, "Embryologist and Stem Cell Pioneer Forms New Company", dated November 25, 2008, as originally reported in Forbes). In the past, side effects from drugs have been tested on animal cells, but rarely with great accuracy, with the result that physicians often prescribe medication to patients without knowing in advance whether or not an individual patient will have side effects to the medication, and then the patient is monitored to see whether or not side effects will occur. Dr. Thomson’s business model instead presents a different paradigm, in which adverse reactions to specific medications would be tested on human, not animal, cells, derived from the human embryonic stem cells, prior to prescribing a drug to a patient. As Dr. Thomson has explained in regard to CDI, "We’re very much going to be focused on products rather than long-term promises. There are things that drug companies want today."

Still, embryonic stem cells are, by their very nature, heterologous vis a vis any living individual, and therefore neither genetic nor immune matching is possible between the embryonic stem cells and the individual who is still alive and in need of the therapy, which thereby also eliminates the possibility of matching drug reactions. By sharp contrast, iPS (induced pluripotent stem) cells, which are derivable from any living person, offer matching not only of genetic and immune profiles but also of pharmaceutical reactions as well. In this regard, even Dr. Thomson has stated, "The world has changed. Over time, these [iPS] cells will be used in more and more labs. And human embryo stem cell research will be abandoned by more and more labs."

As the world’s largest research-based pharmaceutical and biomedical company, Pfizer ranks number one in sales in the world, having reported $48.4 billion in revenue in 2007, from which the company invested $8.1 billion into their own research and development. In January of 2009, Pfizer announced its agreement to buy the pharmaceutical giant Wyeth for $68 billion. Pfizer was founded in 1849 and today employs approximately 81,900 people in more than 150 countries. Pfizer’s launched their Regenerative Medicine unit in November of 2008. (Please see the related news article on this website, entitled, "Business is Booming as Pfizer Targets the Aging Process With New Adult Stem Cell Research", dated November 14, 2008, as originally reported by Bloomberg Press).

Founded in 1848, the University of Wisconsin at Madison today has a staff of over 16,000 employees, more than 2,000 of whom are faculty, and a student body of just under 50,000.

(Please see the related news article on this website entitled, "Pfizer and University College London Form Licensing Agreement", dated April 29, 2009).