Heart Damage in Mice Repaired With iPS Cells

Researchers at the Mayo Clinic in Rochester, Minnesota, have used induced pluripotent stem (iPS) cells to treat damaged cardiac tissue in a mouse model of heart attack. The iPS cells were found to repair the heart tissue both structurally and functionally.

According to Timothy Nelson, M.D., Ph.D., one of the lead investigators of the research, "This study establishes the real potential for using iPS cells in cardiac treatment. Bioengineered fibroblasts acquired the capacity to repair and regenerate infarcted hearts."

Previously, iPS cells had been tested in animal models for three other diseases, namely, Parkinson’s disease, sickle cell anemia, and hemophilia A. This new study is the first of its kind in which iPS cells were tested specifically for their ability to regenerate cardiac tissue.

As Dr. Nelson further explains, "We’re taking advantage of a diseased tissue environment that is sending out a distress signal that is asking the tissue to repair itself. When we put these iPS cells in, they are able to respond. They were able to respond to this damaged environment and spontaneously give rise to the appropriate tissues and create new tissues within that diseased heart. That is a key ‘wow factor’ of this paper. It was obvious to the observer which animals had been treated and which ones hadn’t."

The scientists used fibroblasts which they genetically reprogrammed to dedifferentiate into iPS cells which were then redifferentiated into heart tissue. When transplanted directly into the damaged hearts of the mice, the new cells were found to have engrafted within two weeks of transplantation, and by 4 weeks the transplanted cells were found to have contributed to improved structure and function of the hearts. Not only did the iPS cells halt the progression of structural damage within the heart muscle itself, but the iPS cells were also found to regenerate new cardiac tissue which included not only heart muscle but also blood vessels. Ultrasound also revealed significant improvement in the ability of the hearts to pump blood.

According to Adre Terzic, M.D., Ph.D., Mayo Clinic physician and senior author of the study, "This iPS innovation lays the groundwork for translational applications. Through advances in nuclear programming, we should be able to reverse the fate of adult cells and customize ‘on demand’ cardiovascular regenerative medicine."

However, the researchers still used dangerous viral vectors for dedifferentiation of the fibroblasts into iPS cells, even though other scientists have replaced such methods with less dangerous reprogramming techniques.

Nevertheless, according to Dr. Nelson, he believes that iPS technology will be able to be used in clinical therapies to help people, eventually, even though it might take "several years". Until then, iPS cells are still ineligible for clinical therapeutic use since there are still a number of biological hurdles remaining that have yet to be overcome.

Meanwhile, autologous adult stem cells have already been used therapeutically in the clinical treatment of heart and other conditions, and are already available in clinics around the world – except, that is, in the U.S., where outdated FDA regulations have been unable to keep pace with scientific progress.

Engineering Students Demonstrate Sutures Embedded With Adult Stem Cells

Biomedical engineering students at Johns Hopkins University have announced the successful testing of a practical method for delivering adult stem cells to a patient for the treatment of orthopedic and other types of injuries. Specifically, the undergraduate students have constructed and demonstrated a technique by which adult stem cells are embedded into the surgical thread of sutures that are routinely used in procedures to treat injuries such as ruptured tendons.

The team of students consisted of ten udergraduates who were sponsored by the Maryland-based medical technology company Bioactive Surgical Inc., and who consequently won first place for their design in the recent Design Day 2009 competition, conducted annually by the University’s Department of Biomedical Engineering. The sutures contain autologous adult stem cells, and the students have already conducted preclinical trials of the sutures in animal models, although the ultimate goal is translation of the new technology to human medical therapies.

As described on the University’s website, "In collaboration with orthopedic physicians, the students have begun testing the stem cell-bearing sutures in an animal model, paving the way for possible human trials within about five years."

According to Matt Rubashkin, the student team leader, "Using sutures that carry (autologous adult) stem cells to the injury site would not change the way surgeons repair injury, but we believe the stem cells will significantly speed up and improve the healing process. And because the stem cells will come from the patient, there should be no rejection problems."

The students’ corporate sponsor, Bioactive Surgical, developed the concept and then enlisted the student team to assemble and test the prototype during the year-long Design Team course, which is a requisite course in the Department of Biomedical Engineering. Bioactive Surgical will own the rights to the patent, which are currently pending, and a provisional patent application has also been filed which includes the improvements to the design that were made by the ten members of the Johns Hopkins undergraduate team.

In addition to demonstrating the conceptual validity of the prototype in preclinical animal testing with the assistance of orthopedic veterinarians who conducted the surgical procedures, the undergraduate team also performed a number of other related tasks which included preparing grant applications for additional funding of the technology.

Accordeing to Richard Spedden, CEO of Bioactive Surgical, "The students did a phenomenal job." Representatives of Bioactive Surgical envision a medical procedure for humans in which bone marrow would be withdrawn from the hip of a human patient under general anesthesia, from which mesenchymal stem cells would then be isolated and embedded into the novel suture through the patent-pending proprietary process, which would then be used to stitch together the ruptured tendon or other injured tissue.

In conducting their research, the students found that approximately 46,000 people every year in the U.S. alone undergo surgical repair of an Achilles tendon, which costs approximately $40,000 per surgery and can require a year or more of convalescence. As Matt Rubashkin explains, "After surgery, the recovery process can take up to a year. In about 20% of the cases, the surgery fails and another operation is needed. Anything we can do to speed up the healing and lower the failure rate and the additional medical costs could make a big difference."

According to Dr. Lew Schon, a leading foot and ankle surgeon in the greater Baltimore metroplex, one of the inventors of the technology, and an assistant professor of orthopedic surgery at the Johns Hopkins School of Medicine, "These students have demonstrated an amazing amount of initiative and leadership in all aspects of this project, including actually producing the suture and designing the ensuing mechanical, cell-based and animal trials." Additionally, he adds, "The students exceeded all expectations. They have probably cut at least a year off of the development time of this technology, and they are definitely advancing the science in this emerging area."

Grant proposals which the students prepared include further applications of the novel suture technology to other joint injuries such as rotator cuffs, and to non-orthopedic applications such as in cardiology and obstetrics.

In addition to Matt Rubashkin, the other undergraduate members of the team were David Attarzadeh, Raghav Badrinath, Kristie Charoen, Stephanie D’Souza, Hayley Osen, Frank Qin, Avik Som, Steven Su and Lawrence Wei.

Cord Blood America Highlights 2009 Stem Cell Progress

Cord Blood America Inc. (CBAI), one of the largest providers in the world of umbilical cord blood stem cell preservation, reviews its accomplishments thus far in 2009. Even though the year is only half over, CBAI considers its achievements thus far in 2009 to be among the most significant in the company’s history. Some of its accomplishments in the first half of this year are described herein.

In January: The company launched its first social media campaign in the industry to start a public conversation about the potential usefulness of adult stem cells and the importance of storing umbilical cord blood. Additionally, the company established its "3 pillars of success" for 2009, which are, namely, organic growth, acquisitions, and debt reduction for an improvement in the company’s balance sheet.

In February: CBAI was listed on the ETF Innovators Stem Cell 40 company index. Additionally, CBAI announced $1 million in long-term debt reduction as part of its cash-flow restructuring.

In March: CBAI was noted as the top stock performer on ETF Innovators Stem Cell index, with a year-to-date stock price increase of 279% at that time.

In April: Congress introduced legislation to promote the "Family Banking of Umbilical Cord Blood" stem cells, which is a major boost to the entire cord blood banking industry. Additionally, CBAI received its first customer in Germany and announced a long-term debt reduction of over $2.5 million.

In May: CBAI announced that it had received $2.3 million for the purpose of building its own stem cell processing and storage laboratory, rather than continuing to outsource the services, which thereby resulted in a further debt reduction of $4.2 million.

In June: CBAI announced further expansion throughout Europe as well as independent contracting with affilates in the Caribbean and Central America.

In July: CBAI has further secured $7.5 in long-term equity financing for acquisition and growth opportunities, while also hiring a separate management team to direct its new stem cell laboratories in the U.S., which will be among the largest in the country, construction on which has already begun.

According to Matthew Schissler, chairman and CEO of CBAI, "On January 6, 2009, the closing CBAI stock price was $0.0017. On July 10, 2009, the closing stock price was $0.0033, a 94% increase in 6 months of trading. That’s not where we want to be, we are still very undervalued, and I understand that the day-to-day swings of our very liquid and volatile stock price cause some investor concern. I tell investors to take a snapshot of the last 6 months, not six hours. Micro cap stocks are perhaps not for the faint-of-heart. We believe we’re building a very valuable company and this snapshot of the past 6 months shows our progress."

Additionally, Mr. Schissler adds, "In January, CBAI stated its mission is to lay the foundation for a much stronger, healthier company by the end of 2009, which included organic growth, acquisition and debt reduction. As you can see by these highlights, we remain laser-focused on executing these strategies. Because of our focus, we are able to raise significant funding to build a lab with the future growth opportunities it affords us. We are also pleased by the current support of stem cell research in Washington, D.C. and Congressional and state legislative focus on family stem cell banking legislation."

CBAI is the parent company of Cord Partners, which was founded in 2002 and became operational on January 1, 2003. According to the company’s website, "Cord Partners, a Cord Blood America company, has established itself as a platinum standard national competitor in the umbilical cord blood storage industry… CBAI was founded on a simple principle: The families who seek stem cell preservation should never have to work to achieve this. By bundling such services as medical kit preparation, medical courier arrangement, 24/7 customer service, easy enrollment, and one price for all services, we feel an unparalleled commitment to our clinets, and have the foundation for providing the highest quality stem cell preservation available."

Umbilical cord blood is an extremely rich source of highly potent adult stem cells, such as mesenchymal stem cells and CD34+ cells, which have already been in use for decades in the clinical treatment of various diseases, safely and without side effects. Unlike embryonic stem cells, adult stem cells derived from umbilical cord blood are ethically noncontroversial, as umbilical cord blood is easily and harmlessly collectable.

Adult Stem Cells Treat Scleroderma

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."

Canadian University Announces Major Adult Stem Cell Research Award on Horses

The University of Guelph announces that Thomas Koch has been awarded a three-year post-doctoral fellowship from the Danish Agency for Science, Technology and Innovation which carries over $1 million in funding. The prestigious award is the largest of its kind ever awarded by the Danish funding agency in a highly competitive process. The funding will be specifically applied to research for the development of adult stem cell therapies in the treatment of cartilage injuries in horses, the results of which are expected to be translatable into human therapies. The award includes collaboration between Dr. Koch and other researchers in Canada, Sweden and at Denmark’s largest orthopedics laboratory.

According to Dr. Koch, who earned his DVM from the University of Copenhagen and who had already been using adult stem cells derived from the umbilical cords of foals for the therapeutic treatment and repair of damaged cartilage in horses, "I’m very grateful for this support, which will allow us to carry out the first controlled studies on live animals using the protocols developed here at Guelph for obtaining stem cells from equine cord blood." Additionally, Dr. Koch explains, "This is also great news for U of G and the Ontario Veterinary College because it recognizes that the horse is the premier animal model for studying the potential of using stem cells to repair cartilage injuries. Equine joints are similar to human joints in some respects such as joint thickness, and horses are also prone to spontaneous athletic injuries. So there is a great deal of interest in our work from the equine industry and in human medical circles as well."

Together Drs. Thomas Koch and Dean Betts of the University of Western Ontario have established a protocol for isolating adult mesenchymal stem cells from equine umbilical cord blood, which they have already differentiated into a number of cell types, most notably chondrocytes, from which cartilage is formed.

As Dr. Koch adds, "The goal is to screen these cell lines and pick the ones that are really good at creating cartilage in the lab and then test their regenerative potential in live horses at OVC (Ontario Veterinary College) and Cornell University. If we can make it work in horses, then there is the potential to apply thee same principles to make it work in people, too."

As previously reported a number of times on this website, veterinary adult stem cell medicine is progressing at a rapid pace throughout the world, especially in the U.S. and the U.K., where companies such as Vet-Stem and VetCell, respectively, have independently pioneered their own proprietary methods for the use of autologous adult stem cells in the treatment of a variety of ailments in a variety of animals, especially horses and dogs. To date, Vet-Stem’s procedure has been used to treat more than 2,000 dogs and 3,000 horses in the U.S., with autologous adult stem cells derived from each animal’s own adipose (fat) tissue. Similarly, VetCell’s procedure has been used to treat approximately 1,700 horses in the U.K. to date, and the company is scheduled to begin clinical trials on humans next year. Both companies report an 80% success rate in their animal therapies, significantly higher than that of conventional veterinary medical approaches which average around a 30% success rate.

Now, with such consistent and dramatic results as those documented by Vet-Stem and VetCell, it is hardly surprising that research into such a promising field is expanding throughout other countries, with the awarding of more than $1 million to fund a major collaborative research project between scientists in Canada, Sweden and Denmark.

(Please see a number of other related news articles on this website, which include but are not limited to that entitled, "Veterinary Stem Cell Therapies Translate into Human Therapies", dated July 14, 2009 and originally reported in the MIT Technology Review).

Stem Cells: A New Fad for Cosmetics

There’s a new buzz in the beauty industry, and it has to do with stem cells. For anyone who may be worried about wrinkles and all the other external signs of aging, now there’s a new remedy: creams and lotions with the words "stem cells" in their titles. Though they’re expensive and popular, in actuality none of these products are what they claim to be.

Taking advantage of the new stem cell craze, cosmetics companies are advertising anti-aging creams that purport either to be made from stem cells or to stimulate one’s own naturally occurring endogenous stem cells. With all the hype about stem cells in the media, it’s hardly surprising that commerical businesses would try to capitalize upon the trend, which has a virtually unlimited market potential.

Even in England, a relatively small country, anti-aging creams alone constitute more than a $1 billion industry, per year. In larger countries such as the U.S., and throughout Europe, such a market is staggering. That’s why in September of 2009, Lancome will launch its new anti-aging cream, "Absolue Precious Cells", which comes with the claim that it "will help restore the potential of skin stem cells and bring back the skin of youth." A 50 ml jar of the cream will sell for $237. Contrary to the advertised claims, however, the cream does not actually contain any stem cells, nor does it contain any components of stem cells. Under European and U.K. laws, it would be illegal for any cosmetics to contain human tissue or extracts thereof, and similar U.S. laws also exist. In fact, many doctors and scientists point out that it is impossible to incorporate living cells into creams because the cells would rapidly die. According to Dr. Jeanette Jacknin, an American dermatologist who specialises in anti-aging treatments, "Instead companies are creating products with specialized peptides – made from amino acids – and enzymes – proteins that speed up chemical reactions – or plant stem cells, which they claim help to protect the human skin stem cells from damage or stimulate the skin’s own stem cells." Obiously, such ingredients are vastly different from stem cells.

Currently on the market is another so-called "stem cell" cosmetic product, marketed by the U.K. store Harvey Nichols and known as "Amatokin Emulsion", a 30 ml jar of which sells for $220. Advertisements claim that the cream "awakens the body’s own reservoir of stem cells." Also currently available is "Peau Magnifique" by ReVive, which claims to contain patented ingredients that "convert resting adult stem cells to fresh newly minted cells for a firmer, more defined appearance." A month’s supply sells for $1,450. Additionally, Dior offers a "Capture XP" anti-aging cream which "works on skin stem cells to better repair wrinkles". And don’t forget the Emerge Swiss Apple Stem Cell Serum, which assures its buyers that it will "promote the self-renewal capacity of the skin", for only $120 a jar.

Chris Flower, director of the U.K. trade industry organization known as The Cosmetic, Toiletry and Perfumery Association, says that these products which claim either to contain or to stimulate stem cells have created a "huge potential for confusion". As he describes, "I wasn’t sure what manufacturers meant by the product claims," although it is obvious that the various cosmetics companies merely seem to be "cashing in on the magic allure" of stem cells.

Dr. Bruno Bernard, project director at the Paris research laboratories of L’Oreal, the parent company of Lancome, offers a clarification by stating that their "Absolue" cream contains a new apple extract, not stem cells, which alters the "microenvironment" that surrounds the stem cells that feed the epidermis (the upper layer of the skin) and the dermis (the layer of skin between the epidermis and the subcutaneous tissues), thereby reactivating endogenous stem cells which might be "sluggish" and hence "encouraging the production of new epidermal skin cells, resulting in plumper, younger-looking skin."

Perhaps not everyone wants to have their skin cells encouraged to engage in new production, however. For those who are aware of the possible risks of cancer that some types of stem cells pose through uncontrolled cell growth, Lancome has carefully chosen its wording in order to avoid triggering such fears. The labeling cautiously states that the cream merely "harnesses" stem cell "potential", but does not directly stimulate the growth of new cells. Nevertheless, Lancome also claims that their Absolue cream is the result of 20 years’ research and represents a "decisive breakthrough on stem cells".

Indeed, cosmetics companies pour a hefty portion of their revenue into developing their products, as L’Oreal spends approximately $670 million per year on its laboratory product development. Nevertheless, as Tamara Griffiths, a consultant dermatologist for the British Skin Foundation research charity, explains, even though there may be legitimate scientific research behind a particular product, such as that of Lancome, that doesn’t necessarily mean that the product will reverse the natural process of aging. According to Ms. Griffiths, "The coarse wrinkles and loss of elasticity of the skin, which people commonly associate with an ‘old’ appearance, are due to changes in the collagen and elastic fibres in the dermis. This product will not have any effect on these changes and will not repair damage in the dermis, so the overall impact may be less than consumers’ expectations."

In fact, if a cosmetics product really did have a radical effect upon skin cells, the product would cease to be a cosmetic and would instead fall under the category of a "drug" and would therefore have to be regulated by the same government agencies that set the laws for pharmaceuticals. Most manufacturers of cosmetics, therefore, build definite boundaries and limits into their products.

Fortunately, this means that the products probably won’t hurt anyone. Unfortunately, they might not help anyone either.

As in all other aspects of free market capitalism, "caveat emptor" should be the guiding principle. Especially in the cosmetics industry, appearances can be deceiving.

Arizona Man Travels to Central America for Adult Stem Cell Therapy

In 2003, Mark Palmer was paralyzed from the chest down in a car accident. Now 29 years old, he is currently spending a month in Central America where is he is undergoing adult stem cell therapy.

His wife, Celeste, read about the clinic at ICM – the Institute for Cellular Medicine – which boasts an 80% success rate with its patients. Along with a local charity called Positive Impact, friends and family helped Mark and Celeste raise approximately $30,000 for trip, which includes the cost of the treatment itself as well as related travel expenses.

Currently, adult stem cell therapy is not available in the U.S., despite its wide availability overseas, due to a number of legal reasons which include a lethargic and outdated regulatory system in the U.S. which is in urgent need of reform. Among other problems, the U.S. FDA (Food and Drug Agency) has decreed that each person’s own endogenous, naturally occurring adult stem cells are a "drug" and therefore must be regulated according to the same laws to which pharmaceutical companies must conform. In other words, the FDA has outlawed the use of autologous adult stem cell therapies in the U.S., thereby forcing an increasing number of U.S. adult stem cell companies and physicians to take their business overseas. Only in the U.S. are a person’s own cells considered to be a "drug", with the hardly surprising result that people can obtain adult stem cell therapies just about anywhere at all in the world, except in the United States, which is especially ironic since most of the adult stem cell therapies that exist throughout the world were pioneered either in the United States or by U.S. researchers who have been forced to conduct their research outside of the United States.

A prime example of this legislative dead-end involves the adult stem cell company known as Regenerative Sciences, which found itself at the center of this controversy when, in July of 2008, the founding CEO of the company, Dr. Christopher Centeno, received a letter from the FDA stating that the autologous adult mesenchymal stem cells processed in the company’s prioprietary procedure, Regenexx, are considered to be "drugs" since they are intended for therapeutic use. In the letter, the FDA stated that, "These cells are considered drugs because the therapeutic claims shown on your website demonstrate that they are intended for use in the diagnosis, cure mitigation, treatment or prevention of disease in man." The letter concluded by stating, "Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations… The mesenchymal stem cells utilized in your Regenexx procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in the FDA seeking relief as provided by law."

Regenerative Sciences responded by posting the following notice on their website, which was most recently updated on March 31, 2009: "Last summer we got a letter from the FDA stating that they felt that our Regenexx medical procedure was actually the manufacturing of a new drug. The letter made no sense, as what we’re doing is practicing medicine. We kindly wrote back stating our position and then we didn’t hear back for more than half a year. Recently, the FDA has again asserted that they believe we are manufacturing a drug. They haven’t given any credible rationale for why they believe this, as what we’re doing with adult stem cells is no different than the average fertility clinic that grows embryos in culture for re-implantation. The fertility clinic is not regulated as a drug manufacture facility. The fertility specialists fought that fight and won."

This is a critically important issue, since it illustrates the frustration that many, if not all, adult stem cell scientists in the U.S. feel, as it this stance by the FDA which poses an insurmountable, not to mention entirely illogical, hindrance to the clinical use of adult stem cell therapies in the United States. For anyone who has ever wondered why it is that adult stem cell therapies are available in ordinary clinics in most countries outside of the U.S., but only in a limited number of FDA-approved clinical trials within the U.S., here’s your answer: the FDA considers each person’s own autolgous adult stem cells to be a "drug", and therefore those stem cells are subject to the same multi-year, multi-million-dollar clinical trial process through which all pharmaceutically manufactured drugs must pass before being considered legally marketable within the United States.

A number of grass-roots organizations have been formed, therefore, in order to combat this antiquated stance by the FDA. As the statement on the website of Regenerative Sciences continues: "ASCTA (American Stem Cell Therapy Association) is a physician organization that was formed in opposition to the FDA’s position that adult stem cells are drugs. This group heralds a much bigger movement than what we’re doing here with the Regenexx procedure. We’ve found literally an outcry by patients with chronic diseases that the FDA would stand in their way of getting safe stem cell work performed by their doctors. We agree that there are hundreds of likely unsafe stem cell outfits around the globe injecting God-knows-what into whoever has the will to pay. All the more reason for an organization to step to the forefront to establish physician-run guidelines for safe lab practices and clinical oversight… The pre-clinical research on adult stem cells is much stronger than embryonic stem cells… When I’ve posed the question to numerous doctors and experts in the field, are your own stem cells drugs? They look at me like I’m crazy, and often reply ‘Of course my stem cells aren’t drugs!’ Why would the FDA take the position that your cells are drugs… The ASCTA physician group will be getting out its lab practices guidelines meant to hold new adult stem cell practices to the highest standards to protect patients. Our goal is clear and it’s worth fighting for: Safe Stem Cells Now!"

Likewise, the ASCTA has posted the following statement on their website: "The American Stem Cell Therapy Association (ASCTA) announced today the online publication of its mission statements and charter. The organization was formed in response to the Food and Drug Administration’s (FDA) recent position that the adult stem cells found in everyone’s body are drugs, a position the ASCTA opposes. This physician organization is establishing laboratory guidelines that will allow doctors to bring adult stem cell therapy to their patients more quickly. These guidelines will be similar to those used by fertility specialists in in-vitro fertilization (IVF) labs, where many of the same cell culture techniques are used."

Dr. Centeno, one of the founding members of the ASCTA, is quoted on the ASCTA’s website where he states, "Many patients are dying or suffering daily with incurable diseases or problems that require major surgery. These patients should have access to basic adult stem cell therapy now. ASCTA is establishing guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors." According to Dr. Frank Falco, another ASCTA founding member who is also quoted on the ASCTA’s website, "The FDA’s position against someone using their own stem cells is taking it too far. We are talking about a person using their own tissue to treat a degenerative disorder or process safely without the use of medications or surgery. Although we agree that oversight and standards are necessary, this should be provided through a physician organization such as ASCTA rather than by a government agency."

Not all stem cells are created equal, of course, and it is vitally important that the FDA make distinctions between embryonic, fetal and adult stem cells. In this regard, the ASCTA website continues, "Adult stem cells are different than embryonic stem cells. Adult stem cells are found in the patient’s body in various tissues. In order to obtain enough stem cells for treatment, they often need to be cultured, similar to today’s fertility treatments. Adult stem cells have undergone much more research than embryonic stem cells and therefore are closer to real world treatments. These adult stem cells are taken from the patient’s own body (autologous) and ASCTA believes that they are therefore the safest for use in treating patients." To this Dr. Centeno adds, "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."

As also stated on their website, "The ASCTA is a physician group comprised of various medical and surgical specialists whose goal is to bring safe stem cell therapy to patients by establishing laboratory and clinical guidelines." More information is available at www.stemcelldocs.org.

Additionally, in April of 2009 a patients’ movement called "Safe Stem Cells Now!" was formed in response to the FDA’s unfounded position that a person’s own adult stem cells are "drugs" and therefore should be regulated in the same manner. More information about this organization is available at www.safestemcells.org.

As Barbara Hanson, cofounder of www.stemcellpioneers.com, states, "Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others."

Indeed, many people feel that this stance by the FDA is purely politically and economically motivated. At the very least, it is an entirely unscientific stance, and it is merely one example of the numerous ways in which the FDA needs to update its regulations so that these regulations are relevant and applicable to stem cells, which do not fall into any of the previously existing categories for which the FDA has ever had to formulate national law in the past. Such outdated laws are precisely what is driving many of the best and most accomplished adult stem cell physicians and scientists "off-shore", to set up their laboratories and clinics anywhere at all in the world, just as long as it is outside the borders of the United States. In the end, it is the U.S. patient who suffers, since the researchers and clinicians themselves are not stopped but are merely forced to relocate to other countries. Until the FDA is able to recognize the numerous and vast differences between an autologous adult stem cell and a pharmaceutically manufactured drug, it is no wonder that so many American adult stem cell companies and clinics can be found everywhere throughout the world, except in their own home country, the United States.

Hopefully, someday, the FDA might update its rules and regulations to match the pace of scientific discovery, at which time it might be possible for U.S. citizens such as Mark Palmer to receive adult stem cell therapy in their own home towns, in their own country, without having to travel to foreign countries. Meanwhile, however, at least such therapy is available somewhere, at clinics such as ICM, even if only outside of the United States.

(Please see the related news articles on this website, entitled, "Bangor Family Heads to Central America for Adult Stem Cell Therapy", dated July 8, 2009; "Texas Woman Travels to Central America for Adult Stem Cell Treatment", dated June 25, 2009; and "Two U.S. Adult Stem Cell Companies Form Collaboration in Asia", dated May 11, 2009).

Clinical Results From Embryonic Stem Cells are “Decades Away”

In an article entitled "The Dirty Secret of Embryonic Stem Cell Research", the noted science journalist, author, attorney and director of the Independent Journalism Project, Michael Fumento, writes an eye-opening assessment of the stem cell field.

Michael Fumento begins his article in today’s issue of Forbes by citing the widespread, popular consensus among the general, nonscientific public that cures for all sorts of diseases are imminent, now that the infallible Obama administration has suddenly lifted all restrictions which the nefarious Bush administration imposed upon stem cell research. Such popular consensus, however, is grossly misguided and uninformed, as Mr. Fumento proceeds to demonstrate.

As Mr. Fumento points out, "Quadriplegics probably shouldn’t sign up for the New York City Marathon just yet. If these cures are just around the corner, this corner is far, far away. And that’s according to embryonic stem cell researchers and funding advocates themselves. The time frame for the first of those miracles seems routinely to be given as a ‘decade’, as in ‘a decade away’ or ‘a decade off.’ And it keeps shifting."

Fumento then reminds the reader that in 1998, when Dr. James Thomson isolated the first human embryonic stem cell in the laboratory, it was reported in an article at that time that Dr. Thomson and his colleagues themselves "warn that such clinical applications are perhaps as much as a decade away." That was in 1998, which by now was over a decade ago – and still, as of 2009, there have not yet been any clinical applications, not even one, that have resulted from human embryonic stem cell research. Continuing from the 1998 article, as Fumento then adds, "Check your calendar. Addressing a 2007 Wisconsin convention 9 years later, Thomson articulated that the time frame had shifted to ‘decades away’, plural."

As Fumento goes on to explain, "The scientists didn’t blame too little federal funding, as have others, according to the Associated Press. Rather, Thomson blamed simple biology. Among other problems, embryonic stem cells require permanent use of dangerous immunosuppressive drugs. They have a nasty tendency to form tumors both malignant and benign including teratomas – meaning ‘monster tumor’. Teratomas can grow larger than a football and can contain eyeball parts, hair and teeth." As Fumento further exclaims, "Yech!"

He goes on to ponder, "OK, so how many ‘decades’?" Among others, the answer is given by William Haseltine, former CEO of The Human Genome Project, who told the Agence France Presse in 2001 that, "The routine utilization of human embryonic stem cells for medicine is 20 to 30 years hence", to which Haseltine further added, "The timeline to commercialization is so long that I simply would not invest." There are other embryonic stem cell researchers, however, who believe that "3 to 5 decades" is more realistic, while the British fertility expert and Imperial College, London University professor Lord Robert Winston proclaimed in a 2005 lecture that, "I am not entirely convinced that embryonic stem cells will, in my lifetime and possibly anybody’s lifetime for that matter, be holding quite the promise that we desperately hope they will," further adding that "one of the problems is that in order to persuade the public that we must do this work, we often go rather too far in promising what we might achieve."

Fumento further points out that the 2007 AP article stated, "One day, some believe embryonic stem cells will become sources of brain tissue, muscle and bone marrow to replace diseased or injured body parts." In other words, maybe "one day" in the future, even though such goals have not yet been attained with human embryonic stem cells, not even as recently as 2007 nor even today in 2009. Meanwhile, however, various types of adult stem cells have already been differentiated into these and other types of tissue, decades ago. As Fumento explains, "Life-saving marrow regeneration with stem cells dates back to 1956."

Additionally, "Adult stem cells have now treated scores of illnesses including many cancers, autoimmune disease, cardiovascular disease, immunodeficiency disorders, neural degenerative diseases, anemias and other blood conditions," Fumento points out. "They’ve been used in over 2,000 human clinical trials. There has never been an embryonic stem cell clinical trial. Former National Institutes of Health director Dr. Bernardine Healy, once an embryonic stem cell research enthusiast, now calls them ‘obsolete’."

Indeed, as previously reported a number of times on this website, Dr. James Thomson himself – widely revered as "the father of embryonic stem cell science" – has often emphasized the importance of other types of cells, especially iPS (induced pluripotent stem) cells, over embryonic stem cells. In fact, the company which Dr. Thomson cofounded, Cellular Dynamics International, has as its primary focus today the commercialization of iPS cells, not embryonic stem cells – and not for the development of actual cell-based clinical therapies, but instead for the use of these iPS cells in drug screening and pharmaceutical development. (Please see a number of articles on this website related to Cellular Dynamics International, including but not limited to those entitled, "Leading Researcher Joins Cellular Dynamics", dated July 22, 2009; "Wisconsin Stem Cell Company Announces Licensing Agreement", dated July 15, 2009; "Cellular Dynamics Creates iPS Cells From Human Blood", dated July 8, 2009; and "Cellular Dynamics and Mount Sinai Sign Licensing Agreement", dated May 29, 2009).

As Fumento concludes, "In justifying his stem cell research executive order, President Barack Obama cited ‘a consensus of the majority of Americans.’ Actually, the polling responses vary tremendously depending on the questions asked. But no decision is better than the information upon which it’s based. What might Americans think if they knew the embryonic stem cell reseach ‘decades away’ secret?"

(Please see a number of articles on this website related to the embryonic stem cell versus adult stem cell controversy, including but not limited to that entitled, "Former Director of N.I.H. Explains Why Embryonic Stem Cells are Obsolete", dated March 4, 2009, as originally reported in U.S. News & World Report).

Wisconsin Stem Cell Company Announces Licensing Agreement

In May of this year, Cellular Dynamics International (CDI) announced an exclusive agreement with New York’s Mount Sinai Medical School for the licensing of cardiovascular cells derived from iPS (induced pluripotent stem) cell technology. At that time, representatives of CDI indicated that further licensing agreements would be forthcoming in the near future. Today, CDI issued such a widely anticipated announcement.

The new agreement grants CDI the exclusive in-licensing of a patent portfolio from Dr. Loren Field and Indiana University-Purdue University Indianapolis (IUPUI), within which 2 fundamental concepts are covered, namely, technology for optimizing the differentiation and selection process of cell types, and the specific use of cardiomyocytes in drug testing. The optimization process allows for cell purification with more than 90% purity, which will be applied to a number of cell types although the emphasis will be on cardiomyocytes that are differentiated from pluripotent cells, primarily of iPS (induced pluripotent stem) cell rather than from human embryonic stem cell (hESC) origin.

CDI already boasts a significant patent portfolio, and the new technology will be combined with patents already licensed from WARF (the Wisconsin Alumni Research Foundation), the technology transfer vehicle of the University of Wisconsin at Madison. The ultimate goal of CDI is to create a pipeline for the large-scale mass production of iPS cells that can be used for drug screening by pharmaceutical companies.

According to Chris Kendrick-Parker, chief commercial officer of the company, "CDI is building an industrial pipeline and automated process enabling us to plug in different cell types and generate large quantities of purified cells. That is the primary requirement for commercial application of these cells as tools in the pharmacology and toxicity testing market. Similar to our recently anounced in-licensed patent portfolio from Mount Sinai School of Medicine, the IUPUI agreement ensures that we have a commercial advantage in this area, providing our customers with the comfort that they are unencumbered when they do business with us."

According to Brad Fravel, business development manager at Indiana University Research and Technology Corporation, "As a leader in the pluripotent stem cell field, CDI is a great licensing partner for IUPUI. We are confident CDI will run with this technology, exploiting it to its fullest potential."

As described on CDI’s website, "Under the licensed technology, pluripotent stem cells are engineered to include a selectable ‘marker’. As the stem cells begin to differentiate into different terminal cell types (e.g., heart, blood, neural cells, etc.), the marker allows researchers to identify and select a particular cell type (e.g., heart cells) and produce a highly purified and functional cell population. … While cardiomyocytes are the company’s entree into the market, the company has programs in place for developing multiple cell types, and the Field patents enable the company to develop them into highly purified populations."

Although the new licensing agreement will allow CDI to sublicense the technology to other companies and institutions, specific financial terms of the agreement were not disclosed.

Based in Madison, Wisconsin and co-founded by the renowned embryonic stem cell pioneer Dr. James Thomson along with 3 of his colleagues in 2004, CDI specializes in the development of iPS cells for drug screening. Often referred to as "the father of embryonic stem cell science", James Thomson, VMD, Ph.D., was the first person ever to isolate an embryonic stem cell in the laboratory, first from a nonhuman primate in 1995 and then from a human in 1998. In addition to serving on the Board of Directors and as Chief Scientific Officer of CDI, Dr. Thomson is currently also director of Regenerative Biology at the Morgridge Institute for Research and the John D. MacArthur Professor of Anatomy at the University of Wisconsin at Madison. As described on the website of CDI, Dr. Thomson "is a member of The National Academy of Sciences. His seminal work on stem cell isolation received many awards, including Science Magazine’s ‘Breakthrough of the Year’ in 1999, and he was the cover feature in Time Magazine’s America’s ‘Best in Science and Medicine’ in 2001. In November 2007, Dr. Thomson published another groundbreaking paper describing how differentiated cells can be reprogrammed into a pluripotent state. This isolation of human induced pluripotent stem (iPS) cells was listed among the most significant scientific advances of 2007 in Science, Nature, Time, NBC News, USA Today, The Independent, and Wired Magazine, and Dr. Thomson was named one of Time Magazine’s 100 Most Influential People in the World this same year. Dr. Thomson has published over 112 scientific, peer-reviewed papers and has been an inventor on 14 issued patents. Dr. Thomson received his VMD and PhD from the University of Pennsylvania."

Also clearly printed at the top of CDI’s website is the phrase, "iPS cells deliver". Contrary to popular opinion, and despite his distinguished background in embryonic stem cell (ESC) research, Dr. Thomson is no longer focused exclusively on ESCs but instead has turned his attention to iPS cells, of which he is also a co-discoverer and which he often describes as having a more immediate applicability in medicine than ESCs. Additionally, such an applicability is not so much in the development of actual cell-based therapies as it is in the screening of new pharmaceuticals, as clearly indicated by the commercial direction of CDI’s pipeline.

As further described on their website, "Cellular Dynamics is working with scientists worldwide to develop and deploy a number of cell lineages derived from human pluripotent stem cells (hPSCs) as well as a wide range of screening assays and services to aid pharmaceutical development. Currently CDI provides cardiac toxicity drug testing services, including GLP and non-GLP hERG channel electrophysiological assays as well as action potential and cytotoxicity screens using cardiomyocytes. The company is developing additional cell types from iPS cells, including hematopoietic cells (mast and CD34+ cells, megakaryocytes, and red blood cells), hepatocytes, neural cells, adipocytes, and more."

(Please see the related news article on this website, entitled "Cellular Dynamics and Mount Sinai Sign Licensing Agreement", dated May 29, 2009).

Adult Stem Cells Continue Going to the Dogs

Zack was suffering from a number of degenerative osteoarthritis conditions, despite the fact that he is only 14 years old. Of course, for a dog, 14 is not young. Fortunately for Zack, however, his owner decided to allow him to try stem cell therapy.

According to Deanna Winter, Zack’s owner who is also a doctor for people, "His main problem is arthritis. Trouble walking, trouble sitting and going upstairs." Furthermore, she adds, "His belly was almost touching the ground because he couldn’t hold his hips up. His quality of life was going down. He couldn’t make it around the block anymore."

Dr. Benjamin Ealing at Broad Ripple Animal Clinic in Indianapolis, not far from Zack’s home, has already used autologous adult stem cell treatment on 13 other dogs, successfully in each case. Dr. Ealing surgically removes abdominal fat from the dog, "which about fits in the palm of your hand and fills up two tubes", he describes. The adipose tissue is then shipped to the Vet-Stem laboratories in California where the stem cells are isolated, purified, expanded and returned to Dr. Ealing within 48 hours, already in syringes and ready to be injected into the site of the afflicted joints – which in Zack’s case were a hip and a shoulder. Although results are usually noticeable immediately, the greatest results take about 2 weeks to manifest. Now, two months later, Zack "can walk and he can sit and he can jump and he can go up stairs", as Deanna describes.

As Dr. Ealing adds, "The stem cells are the body’s own natural healing cells. Those cells then recruit the body’s own natural healing cells to come to that area, reduce inflammation, potentially to regenerate damaged tissue."

By now, Zack’s story is becoming an increasingly familiar one. 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.

Since Vet-Stem first began marketing their services, they have now treated more than 2,000 dogs and more than 3,000 horses with autologous adult stem cells, extracted from each animal’s own fat. The procedure 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 $2,500 and $3,500, although the second transplant 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. 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.

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.

A number of companies throughout the world are replicating the procedure pioneered by Vet-Stem. It is fortunate – not only for Zack but also for his 2-legged friends who learn from his example – 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.

(Please see a number of other related news article on this website, which include but are not limited to the most recent one entitled, "Veterinary Stem Cell Therapies Translate into Human Therapies", dated July 14, 2009).