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).

Veterinary Stem Cell Therapies Translate into Human Therapies

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.

New NIH Stem Cell Guidelines are Slowing Research

According to Dr. Steve Duncan, professor of human and molecular genetics at the Medical College of Wisconsin, the failure of the new NIH Guidelines to "grandfather" in the already existing hESC lines has had a "tremendously detrimental effect on our research."

As Dr. Duncan explains, "The problem is they haven’t added the presidential lines as a group of lines that we can now use. So we can’t do any human embryonic stem cell (hESC) research with new federal funds at this point. We’re hoping within the next two months that it will be relaxed, but that’s a long time in research and it’s reallly upsetting, the way it’s been handled."

Once again, as previously reported a number of times on this website, at the heart of the debate are the "voluntary and informed consent" rules which are contained within the new NIH Guidelines. Many, if not all, of the hESC lines that already exist were created before such rules of consent were authored, and therefore do not meet "the core ethical principles and procedures" that are defined in the new NIH Guidelines. Even though NIH says that such hESCs are subject to review by an advisory committee and might therefore be "grandfathered" in, there is still widespread doubt among the ESC scientific community that many of those lines will be approved for the federal funding of research.

In fact, contrary to popular opinion, there is one major obstacle in the U.S. which is preventing stem cell therapies from being available in clinics at this very moment, and that obstacle has nothing to do with NIH nor with embryonic stem cells nor with any restrictions that the Bush administration supposedly imposed nor with any restrictions that the Obama administration supposedly lifted. Instead, that one, single, primary obstacle is the fact that the U.S. FDA (Food and Drug Administration) has decreed that autologus (in which the donor and recipient are the same person) adult stem cells are a "drug", and therefore must be regulated as such, and therefore cannot be used for therapeutic purposes in the U.S. without having first been subjected to the lengthy, lethargic, outdated, multi-year, multi-million dollar federal governmental approval process, in the same manner as which pharmaceutically manufactured drugs are regulated. Such a stance is without any scientific basis whatsoever, and a number of individuals and organizations are attempting to initiate a much-needed and long-overdue reform of the FDA on this issue. Until the FDA is completely overhauled, however, it seems as though U.S. academicians will continue to focus all of their time and attention on arguing over the federal funding of embryonic stem cell research while apparently remaining oblivious to the fact that doctors and patients are not willing to sit around and wait another decade for something to happen, but instead are traveling overseas where adult stem cell therapies are already available in clinics in just about every country in the world except the United States. (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; "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).

Despite all the exaggerated hype over embryonic stem cells, usually at the complete exclusion of adult stem cells, Dr. Duncan nevertheless predicts that future stem cell research will shift more toward adult rather than embryonic stem cells, and not just for the numerous sound scientific and medical reasons but also for ethical reasons as well. Despite his own interest in hESC research at the moment, he also pointed out that, "I think we have to take into account the ethical situation."

BioTime Receives Second Round of Funding

Following a series of recent press releases, BioTime Inc. has announced that two of its shareholders have completed funding of the second tranche of their equity investments by exercising their rights to purchase additional warrants and shares in the company.

Specifically, George Karfunkel and Broadwood Partners, L.P. have each purchased an additional 1,100,000 shares of common stock and 1,100,000 stock purchase warrants, which therefore yielded a cumulative payment of $4,000,000 to BioTime. Although substantially equivalent to the publically traded stock, BioTime’s warrants entitle the investors to the right to purchase additional common shares at an exercise price of $2 per share, before the expiration date of the warrants which is October 31, 2010.

According to Michael West, Ph.D., CEO of BioTime, "The $8,000,000 of new equity capital we have raised since May from these investors, plus our $4,700,000 research grant from the California Institute for Regenerative Medicine, will be available to finance our strategic programs to build our product and technology portfolios in the emerging fields of stem cell research and regenerative medicine. BioTime’s recent steps toward creating an independent board of directors and raising additional capital are consistent with our goal of establishing BioTime as a leader in the emerging field of regenerative medicine, and are necessary steps in qualifying the Company for relisting on a national exchange. BioTime could receive more than $24,000,000 of additional equity capital if all of its class of publicly traded warrants and the warrants sold to Broadwood Partners, L.P. and Mr. Karfunkel are ultimately exercised prior to the October 2010 expiration date."

Headquarterd in Alameda, California, BioTime is focused on the development and commercialization of technology and products related to blood plasma volume expanders for use in emergency trauma treatment, surgery and related applications. Its wholly owned subsidiary Embryome Sciences is "focused on developing an array of research and therapeutic products using human embryonic stem cell technology", as described on the personal website of Michael West, Ph.D., molecular gerontologist and BioTime’s CEO. Prior to his work with BioTime, Dr. West founded the Geron Corporation, which received FDA approval earlier this year to commence the first human clinical trials ever to be conducted with hESCs.

Contrary to widespread misconception, embryonic stem cell research has been alive and well for years in the U.S., even throughout the entirety of the Bush administration, and nowhere is there a better example of this fact than in the continued funding by private investors of embryonic stem cell companies such as BioTime and Geron. Such investors apparently have unlimited supplies of patience as well as money, however, since embryonic stem cell research has yet to yield any concrete, tangible results which can actually be applied to clinical therapies.

BioTime’s stock closed slightly higher today, at $3.20.

(Please see the related news articles on this website, including those entitled, "New Members Added to BioTime’s Board of Directors", dated July 7, 2009, and "BioTime Announces Agreement With Millipore", dated July 9, 2009).

NIH received varied responses, some poignant, on stem-cell draft

President Obama issued Executive Order 13505 on March 9, 2009, to establish policy and procedures under which NIH (National Institutes of Health) will fund research in the area of embryonic stem cells. Previously, embryonic stem cell research was legal in the US, as long as it was not funded by the NIH. However, NIH funded research in embryonic stem cells could be conducted as long as it involved existing embryonic stem cell lines, and not creation of new ones. As a response to the Executive Order, the NIH generated draft Guidelines that would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose.

There were approximately 49,000 comments sent into the NIH in response to a publicly available draft of the new guidelines to embryonic stem cell research (see for yourself at http://grants.nih.gov/stem_cells/web_listing.htm). According to the article by Nancy Frazier O’Brien of the Catholic News Service, although many of them were repetitive, some made clear the point that destruction of human embryos should not be permitted. For example, one comment was:

"As a mother of a child with juvenile diabetes, I certainly hope we find a cure for this terrible disease in her lifetime," wrote one woman. "However, I am not willing to sacrifice the life of ONE CHILD, let alone thousands or even more in the name of research.

Currently much research is being performed on embryonic stem cells in order to develop treatments and eventually cures for diseases that currently are incurable. At least this dream is what inspires many to support embryonic stem cell research. Unfortunately, much of the political debate, at least in our opinion, seems to be just that: politics.

The whole purpose of medical research is the development of new treatment that help people. This is not to say that there is something wrong with doing research for the sake of doing research. After all, many of the greatest advancements of humanity came about by accident when people were not looking for them. So there is a point to doing basic research for the sake of basic research. However, the media and the political debates around embryonic stem cells are giving the impression that if people do not support embryonic stem cells, they are not supporting cures for their children with diabetes, or their parents with Alzheimer’s or Michael J Fox’s Parkinson’s. In fact, nothing could be farther from the truth.

The field of embryonic stem cell research is based on the finding that if one takes a fertilized egg and extracts specific cells after the fertilized egg has developed to a certain point, these cells, can give rise to every cell in the body. Interestingly, these "master cells" can be grown in high quantities under special conditions so that they can be used for experiments. For example, these embryonic stem cells can be treated with certain chemicals and make muscle cells in the test tube. These cells can be treated with other chemicals and make brain cells in the test tube. These cells can make almost any cell known to mankind when manipulated in the test tube. This sounds very exciting. This is why many people are very excited about embryonic stem cell research.

Now the problem is a little more complex.

When these "master cells", these embryonic stem cells, are placed into a mouse that has been induced to have a heart attack, what happens to these cells? Unfortunately, what happens, is that the mouse developed more inflammation, or some mice develop a cancer called a teratoma. So the beautiful and exciting work in the test tube, has so far largely failed to produce therapeutic results in animals. We know that cancer has been cured in animals for decades now, yet some many humans still die of cancer. If we can not induce cures in animals with embryonic stem cells, then how likely are we to induce cures in humans in the near future?

Exactly. The point that embryonic stem cell advocates make, the ones that have some familiarity with medical science (which most don’t), is that just because embryonic stem cells are not useful today does not been that they will not be useful tomorrow. That research dollars need to be spent on embryonic stem cells so that one day they may be useful.

We can not argue with the point of supporting basic research. However, our position is that basic research should be seen as basic research and should not be transformed into a "religion".

There are several points that need to be made that are not made out of belief, or politics, or even religion, but are based on scientific facts:

Firstly, embryonic stem cells have made medical progress already. The creation of genetically engineered mice (knockouts and transgenics) was soley dependent on mouse embryonic stem cells. Practically everything we know scientifically about the function of molecules in living things has been derived from these animals. Accordingly, the blanket statement that embryonic stem cells have produced no benefits is incorrect.

Secondly, adult stem cells have been used already in patients with various degrees of success. For example, in patients with heart failure, analysis of over 1000 patients indicated overall improvement of heart function. Now where would money and funds be better spend? Taking something that seems to work and making it applicable to everyone, or chasing a distant dream?

Thirdly, embryonic stem cell research, from a scientific perspective, is rapidly becoming obsolete. The moral and ethical issues surrounding embryonic stem cells arise from the need to destroy the embryo to extract the embryonic stem cells. The new technology called inducible pluripotent stem cells (iPS) allows for the generation of brand new embryonic-like stem cells from skin, bone marrow, brain, and pretty much any other tissue. What many supporters of embryonic stem cells do not know is that iPS cells are more attractive to scientists because: a) they can be easily generated; b) they offer potential to make "brand new", "clean" cells, without having to rely on embryonic stem cells that are years old and have undefined characteristics; and c) iPS cells allow the possibility to make stem cells from the same patient.

On July 6th, 2009 Dr. Raynard S. Kington, acting NIH director, made final the guidelines and approved funding for research involving the creation of new ES cells. The question now becomes how much of the funding should support ES research and how much support with the other stem cell technologies be given, the technologies that actually seem to be inducing benefit in people today?