President Obama accomplished three major goals of his today: 1/ the signing of an Executive Order that reversed President Bush’s restrictions on federal funding for some, but not all, types of human embryonic stem cell research, 2/ the overturning of one of President Bush’s Executive Orders which encouraged stem cell research beyond embryos, such as with adult stem cells and iPS cells, and 3/ the issuing of a “presidential memorandum” calling for “scientific integrity in government decision-making”.

Perhaps just as important as what he did today is what he did not do today, since President Obama did not change any of the laws that prohibit the use of federal dollars for the destruction of human embryos. In fact, he is unable to change such laws, since such changes require more than a presidential Executive Order, namely, they require Congressional approval. Consequently, these laws remain unchanged, and it is still illegal to use federal funds to extract embryonic stem cells, and thereby to create new embryonic stem cell lines, from a human embryo.

In order to understand the significance of these actions, and inactions, it is important to review the background and context in which they took place. Described below, therefore, is a brief review of each the aforementioned 3 actions.

1/ In regard to President Obama’s Executive Order overturning President Bush’s restrictions on federal funding for some, but not all, types of human embryonic stem cell research:

As every stem cell scientist remembers, August 9th of 2001 was the date when President George W. Bush made his speech to the nation in which he announced that the use of federal money for embryonic stem cell research would be limited to those embryonic stem cell lines that were already in existence prior to that date, August 9th of 2001. Contrary to widespread misunderstanding among the general public, President Bush did not prohibit embryonic stem cell research, but instead, he only prohibited the use of federal money – in other words, taxpayer dollars – for the funding of research conducted on embryonic stem cell lines that were created after August 9th of 2001. He did not prohibit the use of federal money for research conducted on embryonic stem cell lines that already existed prior to August 9th of 2001, nor did he prohibit the use of private funding (non-taxpayer dollars) for research on embryonic stem cell lines created at any time, whether before or after that date. As The New York Times reported the following day, on August 10th of 2001, “Research in the private sector is unaffected by Mr. Bush’s statement.” Indeed, embryonic stem cell research has been conducted throughout the U.S. over the past 8 years, during the entire Bush administration, in a perfectly legal manner, either through private funding or through the use of federal funding on the research of embryonic stem cell lines that already existed prior to August 9th of 2001. In fact, even though he was personally opposed to embryonic stem cell research on ethical grounds, President George W. Bush nevertheless became the first U.S. president ever to allow the use of federal funds for human embryonic stem cell research, at all. Compared to President Clinton, President Bush actually expanded the federally funded embryonic stem cell research program, merely by creating it, since it did not exist at all under Clinton, and the main legislative restrictions that are erroneously associated with President Bush were, in actuality, already in place under the Clinton administration. (Please see the section below on the Dickey-Wicker Amendment). Prior to President Bush, no federal funds were available, at all, for any type of human embryonic stem cell research. When Bush gave his historic speech on August 9th, 2001, which was his first formal address to the nation since his inauguration, the main point of significance was not that he was restricting the use of federal funds to exclude only a certain subset of all types of stem cells, but rather the main point of his speech was that he was allowing, for the first time in history, the use of federal funds for any type of human embryonic stem cell research at all, since he was the first U.S. president ever to permit such a thing.

Be that as it may, today, in keeping with one of his campaign promises, Barack Obama has overturned President Bush’s restriction on the use of federal funding for research conducted on human embryonic stem cell lines that have been created after the date of August 9th, 2001. The precise implications of this, however, are not, in general, well understood.

What President Obama did, specifically, by issuing a new Executive Order, is that he has now made it possible for federal funding – taxpayer dollars, i.e. – to be spent on research conducted on human embryonic stem cell lines that have been created both before and after August 9th of 2001. In other words, this new policy now makes it possible for NIH (the National Institutes of Health) to award grants to scientists, most of whom are primarily in academia, who wish to conduct research on human embryonic stem cell lines that have, somehow, already been created up to the present time, now and into the future. “Somehow” is the key word, however, since there’s a “catch-22” in Obama’s new Executive Order, which conceals the fact that it is still illegal to create such human embryonic stem cell lines, at least with federal funds, because it is the mere process of establishing a new embryonic stem cell line that destroys the embryo from which the embryonic stem cells are extracted. As of today, it is now legal to perform research on those cell lines that already exist, but it is still not legal to create new cell lines – because it is still illegal to destroy human embryos, at least with federal tax dollars, and no one can create a new embryonic stem cell line without also destroying the embryo from which the stem cells were extracted. These restrictions are specifically stated in something called the Dickey-Wicker Amendment, which Obama renewed by signing into law a mere 2 days after overturning President Bush’s Executive Order today. But we’re jumping ahead in time, and we’ll come back to that point later.

Meanwhile, to return to the topic of what it was exactly that Obama did overturn today, let’s look at the National Institutes of Health. NIH is an agency within the Department of Health and Human Services and it is the branch of the U.S. federal government that provides federal funding to researchers in the biomedical sciences. President Bush’s 2001 funding restrictions meant that NIH could not award grants to embryonic stem cell researchers who wanted to conduct research on human embryonic stem cell lines that were created after August 9th, 2001, even though NIH was still allowed to award grants to embryonic stem cell researchers who wanted to conduct research on human embryonic stem cell lines that had already been created prior to August 9th, 2001. But if anyone wanted to conduct research on a human embryonic stem cell line that was created after that magic date of August 9th of 2001, they would have to find private funding (non-taxpayer, non-NIH dollars, i.e.) for such research, and that is exactly what numerous scientists did. One of the major complaints about this restriction was the extra accounting work required of scientists who, for example, were already receiving NIH grants for some research, but who were disqualified from receiving NIH grants for embryonic stem cell research, and who therefore were able to find private, non-NIH funding in addition to their NIH funding, but who consequently could not intermix laboratory equipment and could not even use NIH-funded microscopes or petri dishes for non-NIH funded research. As a result, many scientists had to construct entirely separate laboratories, one for NIH-funded research and one for non-NIH-funded research, just to be able to keep the financial accounting and inventory separate, and to avoid being in violation of federal law. But despite such inconveniences, the non-NIH funded research continued anyway, just as vigorously as did the NIH-funded research. The major complaint among scientists was therefore not that President Bush’s federal funding restrictions prevented embryonic stem cell research altogether, since that is not what President Bush’s restrictions did, nor is that what President Bush intended the restrictions to do, and indeed embryonic stem cell research has thrived in the intervening years since August 9th of 2001, with private funding from such organizations as the Howard Hughes Medical Institute, for example, which has awarded much of the funding to scientists such as Dr. Douglas Melton of the Harvard Stem Cell Institute, among others. Similarly, when Dr. James Thomson at the University of Wisconsin at Madison skyrocketed to instant fame when he became the first person to isolate a human embryonic stem cell in 1998, his research had been conducted with private funding from the Geron company, not with federal government (NIH) funds. President Bush’s restrictions did not stop embryonic stem cell research from continuing, nor from flourishing, but instead his restrictions only applied to the use of federal taxpayer dollars for a specific subset of all embryonic stem cell research. It was the new complexities in laboratory inventory and accounting methods that were created by President Bush’s restrictions which scientists in academia did not appreciate, and which constituted the primary complaint against President Bush’s federal funding restrictions. (Please see the related news article on this website, entitled, “Former Director of N.I.H. Explains Why Embronic Stem Cells are Obsolete”, dated March 4, 2009, and originally reported in U.S. News and World Report, for an excellent clarification of this fact).

However, despite the publicity and fanfare that accompanied President Obama’s action in reversing President Bush’s federal restrictions today, the primary “hindrance” to embryonic stem cell research still exists, and it remains beyond President Obama’s reach since something more than a president’s signature will be required to overturn it. First enacted into law under the Clinton administration in 1995, the Dickey-Wicker Amendment specifically bans federal funding for any “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death”. Since the extraction of embryonic stem cells from an embryo results in the immediate destruction of that embryo, such language pertains directly to the creation of new embryonic stem cell lines. It is precisely the creation of new embryonic stem cell lines, however, that embryonic stem cell scientists covet the most – not the authorization to spend federally awarded grant money on already existing embryonic stem cell lines, which number very few in quantity, even after Obama increased the number to include those embryonic stem cell lines that were created after August 9th of 2001. In regard to the actual creation of new embryonic stem cell lines, President Obama has changed nothing, nor does he have the power to change anything by himself since only Congress, not the president, can overturn the Dickey-Wicker Amendment. Apparently, there are not many people in the general public who understand this point, and one wonders if even Obama and his own advisors were at all aware of it. Those who do understand the Dickey-Wicker Amendment wonder what all the hype and fuss were about, since Obama’s highly publicized overturning of President Bush’s federal restrictions have resulted in changes that are resoundingly insignificant.

To recap the key points: it is still illegal, therefore, for federal funds to be used for establishing new human embryonic stem cell lines, since such a laboratory procedure results in the destruction of the human embryo, and this is still illegal under the Dickey-Wicker Amendment – which, not surprisingly, some members of Congress are actively mobilizing their efforts to overturn. Nevertheless, the Dickey-Wicker Amendment only applies to the use of federal money, not to the use of private (non-taxpayer) money, so it is still perfectly legal, as it has always been, to create and destroy as many human embryos as one wants, as long as one uses private funding instead of federal funding to do it. Named after its authors, Representatives Jay Dickey of Arkansas and Roger Wicker of Mississippi, the Dickey-Wicker Amendment was originally passed in 1995, under the Clinton Administration, as a rider attached to the appropriations bill for the Department of Health and Human Services, and Congress has actively voted to renew the Amendment every year since then, although that could change by the end of this year. To reiterate, as should be obvious by the date on which this Amendment was created, it was President Bill Clinton who signed the Dickey-Wicker Amendment into law, not President George W. Bush, who merely inherited it.

It would seem as though at least one person in Obama’s inner circle is aware of the existence of the Dickey-Wicker Amendment, and that would be Dr. Harold Varmus, president of Memorial Sloan-Kettering Cancer Center in New York City and co-chairman of Obama’s science advisory council. In reference to President Obama’s highly publicized actions today, Dr. Varmus has cautioned that, “The president is, in effect, allowing federal funding of human embryonic stem cell research to the extent that it’s permitted by law – that is, work with stem cells themselves, not the derivation of stem cells.” But ask any embryonic stem cell scientist, and he or she will confirm that it is precisely “the derivation of stem cells” that they want, but that is not something which Obama can give them.

There are many U.S. taxpayers who object as a matter of principle to the idea that their hard-earned taxpayer dollars will now be specifically allocated for the deliberate destruction of human embryos, and there are many people who believe that such research, if it is to be legal at all, should remain within private industry. As already explained, President Bush did not ban the research itself, he only banned the use of taxpayer dollars to fund the research. According to House Republican Leader John Boehner of Ohio, “I fully support stem cell research, but I draw the line at taxpayer-funded research that requires the destruction of human embryos, and millions of Americans feel similarly.”

In reference to the hype and ostentatious fanfare surrounding Obama’s widely misunderstood actions today, House GOP Whip Eric Cantor of Virginia states, “Unfortunately, today the administration wasted an opportunity to unite our country around ethically and scientifically sound innovations by allowing the use of taxpayer money for embryo-destructive stem cell research, which millions of Americans find morally reprehensible. This divisive action will divert scarce federal resources away from innovative and proven adult stem cell research.” Indeed, regardless of the date at which an embryonic stem cell line was, or will be, created, the embryo from which the stem cells were derived is destroyed.

Nevertheless, contrary to popular misconception, Obama’s new policy still does not allow the use of federal money to destroy human embryos, and it also still does not allow the creation of new human embryos; it merely increases the number of already-established human embryonic stem cell lines on which research may be conducted. Consequently, many scientists insist that the new Executive Order is not enough, and that federal funding should also be allowed for the destruction of new embryos via the creation of new embryonic stem cell lines. In regard to overturning the Dickey-Wicker Amendment, however, Obama has not yet formally expressed an opinion on the matter, even though his opinion, alone, whatever it may be, will not be enough to overturn the Amendment since only Congress has the power to do that.

Obama’s Executive Order directs NIH (the National Institutes of Health) to develop revised guidelines on federally funded embryonic stem cell research within 120 days. Such guidelines will determine such things as, for example, how embryonic stem cell lines will be obtained for research purposes and what will constitute proper “consent” from those who donate the embryos, etc.. The nation will therefore have to wait another 4 months in order to learn exactly what it is that NIH will recommend.

2/ In regard to the overturning of one of President Bush’s Executive Orders which encouraged stem cell research on non-embryonic sources, such as with adult stem cells and iPS cells:

Among other national policies that were signed into and out of law today with the stroke of a pen, Obama also formally rescinded President Bush’s Executive Order that advocated research into non-embryonic sources of stem cells, such as adult stem cells and iPS cells.

The Executive Order which Obama signed today formally and officially rescinded Executive Order 13435, which President Bush signed into law on June 20th of 2007, and which pushed the Secretary of Health and Human Services to “conduct and support research” on stem cells that “may result in improved understanding for treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus”. In other words, President Bush’s Executive Order encouraged the development of therapies derived from research conducted on adult stem cells and on iPS (induced pluripotent stem) cells, but Obama’s Executive Order has now specifically overturned, repealed and annulled any such initiative for the promotion of research on non-embryonic sources of stem cell therapies.

In response to President Bush’s 2007 Executive Order, the NIH (the National Institutes of Health) drew up a plan at that time for implementing President Bush’s order, in which the NIH authors stated that, “Adult stem cells, such as blood-forming stem cells in bone marrow … are currently the only type of stem cell commonly used to treat human diseases.” Indeed, the only type of stem cell research that has ever yielded an actual treatment for anything is adult stem cell research, which is already being used in clinics around the world for a wide variety of diseases and injuries. By sharp contrast, embryonic stem cells have never resulted in even one therapy for anything.

President Obama is not without his critics, especially in his decision to rescind this particular Executive Order of President Bush, which did not prohibit anything but instead specifically encouraged further research with adult stem cells and with other non-embryonic sources of adult stem cells, such as iPS cells. One such critic of Obama, the bioethicist Wesley Smith, points out that Obama is putting politics and ideology above science – the very thing that Obama accuses his predecessor of doing. According to Wesley Smith, “I can think of only two reasons for this action, for which I saw no advocacy either in the election or during the first weeks of the Administration: first, vindictiveness against all things ‘Bush’ or policies considered by the Left to be ‘pro-life’; and second, a desire to get the public to see unborn human life as a mere corn crop ripe for the harvest. So much for taking the politics out of science!”

The precise reasons why Mr. Obama decided to overturn an Executive Order that sought to attain stem cell therapies from non-embryonic sources such as adult stem cells and iPS cells, remains unknown. Apparently, rather than wishing to remove restrictions on research, as he claims, Mr. Obama instead prefers to impose restrictions on research. Additionally, one would think that “a man of faith”, as President Obama describes himself, would be in favor of such research and development purely on ethical grounds, if not also on scientific grounds, which are considerably more compelling for adult stem cells than for embryonic stem cells. To the contrary, however, today’s “soaring rhetoric” by President Obama, if not his actions, demonstrates not only that he is strongly pro-embryonic stem cell research, at all costs, but also that he is strongly anti-adult stem cell research, at all costs. And despite the fact that Obama failed to remove the primary legislative “obstacle” to embryonic stem cell research, because no president has the power to do so, and therefore the legal policies have changed only negligibly since the Bush administration, nevertheless Obama is widely and mistakenly given credit for having instantly changed and improved everything.

According to House Minority Leader John Boehner of Ohio, “Advancements in science and research have moved faster than the debates among politicians in Washington, D.C., and breakthroughs announced in recent years confirm that the full potential of stem cell research can be realized without the destruction of human embryos.”

As Republican Senator Richard Shelby of Alabama adds, “My basic tenet here is I don’t think we should create life to enhance life and to do research and so forth. I know that people argue there are other ways. I think we should continue our biomedical research everywhere we can, but we should have some ethics about it.”

(Please see the related article on this website, entitled, “Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research”, dated March 10, 2009).

3/ Finally, in regard to the issuing of a “presidential memorandum” calling for a return of “scientific integrity to government decision-making”:

In an op-ed article published in the Washington Post and entitled “Obama’s ‘Science’ Fiction”, the Pulitzer Prize-winning syndicated columnist and commentator, Dr. Charles Krauthammer, issued a scathing rebuttal of Obama’s actions today, including the issuing of this “presidential memorandum” in which Obama pretentiously called for a return of “scientific integrity to government decision-making”. Dr. Krauthammer, who is also a former U.S. Presidential Science Advisor to the Carter Administration as well as a graduate of Harvard Medical School, and who has been a paraplegic since 1972, was personally invited by President Obama to attend the White House signing ceremony today, but he rejected the invitation. In his Washington Post op-ed article, Dr. Krauthammer writes, “…the ostentatious issuance of a memorandum on ‘restoring scientific integrity to government decision-making’ – would have made me walk out. Restoring? The implication, of course, is that while Obama is guided solely by science, Bush was driven by dogma, ideology and politics. What an outrage. Bush’s nationally televised stem cell speech was the most morally serious address on medical ethics ever given by an American president. It was so scrupulous in presenting the best case for both his view AND THE CONTRARY VIEW that until the last few minutes, the listener had no idea where Bush would come out. Obama’s address was morally unserious in the extreme. It was populated, as his didactic discourses always are, with a forest of straw men. Such as his admonition that we must resist the ‘false choice between sound science and moral values.’ Yet, exactly 2 minutes and 12 seconds later he went on to declare that he would never open the door to the ‘use of cloning for human reproduction.’ Does he not think that a cloned human would be of extraordinary scientific interest? And yet he banned it. Is he so obtuse as not to see that he had just made a choice of ethics over science? Yet, unlike Bush, who painstakingly explained the balance of ethical and scientific goods he was trying to achieve, Obama did not even pretend to make the case why some practices are morally permissible and others are not.” (Please see the related article on this website entitled, “A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama’s Policy”, dated March 13, 2009).

Indeed, the implications extend further than merely to President Bush, as Obama is insinuating that the countless distinguished doctors and scientists who choose to work only with adult stem cells and not with embryonic stem cells, are all driven only by dogma, ideology and politics, whereas the other half of that insinuation is that anyone who advocates embryonic stem cell research (such as the many politicians and Hollywood movie stars) must be motivated only by scientific integrity. In fact, all of the evidence, including the scientific facts, strongly indicate that the exact opposite is true. And most of the doctors and scientists who choose to work exclusively with adult stem cells, and who refuse to go near embryonic stem cells, do so because of the numerous compelling scientific reasons, regardless of their own individual ethical convictions.

Additionally, to call for “scientific integrity in government decision-making” seems to be a strange contradiction of Obama’s concurrent action overturning President Bush’s Executive Order which specifically encouraged the research and development of stem cell therapies beyond embryonic stem cells, such as with adult stem cells and iPS cells. If nothing else, today President Obama made it perfectly clear that he is strongly opposed to beneficial therapies that are developed from adult stem cells and iPS cells – despite the fact that a wide variety of adult stem cell therapies already exist.

Summary:

Other than the rather mystifying and surreptitious reversal of a Bush Executive Order which did nothing other than call for the research and development of stem cell therapies from non-embryonic sources, and which limited nothing, and which only encouraged research into promising adult stem cell treatments, the only thing that Obama has managed to change today in regard to Bush-era restrictions is that scientists are now allowed to spend their NIH grant money on human embryonic stem cell lines that are somehow currently already in existence. Such stem cell lines are estimated to number in the hundreds, which is more than the approximately 21 embryonic stem cell lines that had been in existence prior to August 9th of 2001, but it is hardly enough to satisfy the research objectives of every embryonic stem cell scientist in every embryonic stem cell laboratory in the country. In order to do that, it would be necessary to legalize the use of federal funds for the destruction of embryos, which is necessary for the creation of new embryonic stem cell lines, which would require overturning the Dickey-Wicker Amendment, which Obama does not have the power to overturn since only Congress, not a president, can overturn such an Amendment.

Beyond that simple change – namely, expanding the applicability of federal funds from approximately 21 human embryonic stem cell lines to a few hundred human embryonic stem cell lines – and in addition to the momentous denial of the importance of adult stem cell and iPS cell therapy, nothing else is different from the stem cell policies that existed during the Bush administration. The main legislative restriction of primary importance, the Dickey-Wicker Amendment, which predates President Bush and which originated under the Clinton administration, and which still makes the federally funded destruction of human embryos illegal, has not been reversed, and cannot be reversed by any president. (Please see the related news article on this website, entitled, “Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research”, dated March 11, 2009, which further addresses this issue).

Overall, the main goal that Mr. Obama accomplished today was to exhibit his own, personal vindictiveness against the previous administration. But nothing that he decreed in his ceremonial signing today had anything whatsoever to do with “scientific integrity”.

In what CNN referred to as “a thinly veiled criticism of his predecessor”, Obama made a number of claims today which left many people in his national and international audiences questioning the logic and “scientific integrity” of everything that they heard the president announce.

The Japanese biotech company, JCR Pharmaceuticals, has announced that it has begun clinical trials for the treatment of graft-versus-host disease (GVHD) with its proprietary product, known as JR-031, which consists of a patented preparation of human mesenchymal stem cells derived from bone marrow.

GVHD is a common and potentially fatal complication of allogeneic (in which the donor and recipient are not the same person) bone marrow transplantation, for which a reliable cure has not previously existed. Conventional treatments with corticosteroids which are intended to induce T-cell immune suppression carry a high risk of infection and cancer relapse. Now, however, adult stem cells offer the first actual therapy which has already been shown to halt and reverse GVHD, without imparting further dangers and risks to the patient.

JR-031 uses adult stem cell technology originally developed by the U.S. company Osiris Therapeutics, which is currently in Phase III clinical trials with its human mesenchymal stem cell products in Europe and the U.S., where the therapy has received Fast Track designation from the corresponding regulatory agencies for the treatment of GVHD. In Japan, where Phase I and II clinical trials will be conducted at more than ten hospitals, JCR Pharmaceuticals is developing the therapy in collaboration with the Mochida Pharmaceutical Company. Some patients have already been treated with JR-031, and data should be available within the next few months. If Japan’s Ministry of Health approves JR-031, as expected, this mesenchymal stem cell product will then become the first stem cell-based therapy in Japan. In anticipation of successful clinical trials in Japan, as already demonstrated by the success of clinical trials conducted by Osiris in the U.S. and Europe, JCR Pharmaceuticals and Mochida have already entered into a formal agreement in which both companies will co-develop and commercialize JR-031 for Japan.

JCR Pharmaceuticals is focused on the R&D of human-derived bioactive substances, especially enzyme-, hormone-, and cell-based therapies for orphan diseases. The company was founded in 1975 and is based in Ashiya City, Japan. It is traded on the Osaka Stock Exchange under the symbol JCRPF.

Zoey, the 14-year-old American Eskimo dog, used to suffer from advanced arthritis of the hip, but found no improvement with pharmaceuticals, and hip surgery was contraindicated by his advanced age. Fortunately, however, Zoey’s owner followed the advice of Zoey’s veterinarian, and now Zoey’s hip and quality of life have both significantly improved, thanks to canine adult stem cell therapy.

According to Zoey’s owner, Raymond Walsh, “It did wonders. He is having another round. But had we not given the first shot back in August we might have had to put him under.”

Since Vet-Stem began marketing their services last year, they have now treated more than 1,500 dogs and cats 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 typically run between $2,500 and $3,500, although the second transplant will often cost much less since extraction is only necessary once. In Zoey’s case, additional injections of his own stem cells cost $350 each. As his owner Raymond puts it, “If it prolongs his life, it was worth it.” The entire stem cell extraction procedure consists of the approximate equivalent of 2 or 3 tablespoons of the animal’s own adipose tissue (fat) which is surgically removed under anesthesia and shipped overnight to Vet-Stem’s laboratories in southern California where the stem cells are isolated, expanded 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 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.

Success stories are common in the field of veterinary medicine with this type of stem cell therapy, which utilizes exclusively adult stem cells, not embryonic stem cells, since embryonic stem cells are notoriously problematic and carry a number of dangerous risks, both in humans and in animals, not the least of which is the formation of teratomas (tumors).

Another success story involved the 7-year-old golden retriever named Daisy who, in the summer of last year, received the same type of autologous adult stem cell procedure as did Zoey, at which time adult stem cells derived from Daisy’s own fat were injected into both of her hind legs. Although she had previously been unable to walk at all on her left hind leg, she was restored to effortless and painless mobility following the stem cell treatment. According to her owner, Mary Benik, “She is back to what she was. Before, she had been holding her foot up, favoring it. I hope it continues to work because I have bad knees and I would do it if it could help me.”

In fact, Vet-Stem’s consistent success is becoming increasingly difficult for the human medical profession to ignore, and pioneering patients such Zoey and Daisy are now inspiring similar therapies for humans. According to the CEO of Vet-Stem, Dr. Bob Harman, “When you look at a labrador retriever with arthritis in his hips, that is the same disease that you and I have. Fractures are similar too, even though they are four-legged.”

Indeed, Vet-Stem is now working with the San Diego company Cytori Therapeutics which is harvesting adult stem cells from human adipose tissue for reconstructive breast surgery following a masectomy, by utilizing a proprietary device that has already been approved for use with breast cancer patients in Europe. According to Tom Baker, director of investor relations at Cytori, “Our first application is taking the cells out and combining them with fat to allow fat to be used as a natural filler in breast reconstruction.” Although this is just one example of a very specific application of adult stem cell technology, other applications extend throughout the vast spectrum of degenerative diseases and traumatic injuries, including those of orthopedic, cardiovascular, neurological and immunological origin, in which there is no shortage of companies that have already demonstrated impressive results in human clinical trials, such as, most notably, the adult stem cell company Osiris Therapeutics, among others.

Once again, in a symbiotic relationship that can trace its origins back throughout the millennia, it is unclear today exactly who is training whom, and who is really helping whom, in the ongoing mutual advancement and enlightenment of homo sapiens and our canine companions.

After isolation and in vitro expansion over several months of autologous neural stem cells that had been obtained from cortical and subcortical tissue samples of a patient during neurosurgical procedures, the neural stem cells were then carefully examined for safety, function and differentiation. It was not until nine months after harvesting of the cells that the researchers administered unilateral microinjections of the autologous cell suspensions containing differentiated dopaminergic and GABAergic neurons into the brain of a patient with advanced Parkinson’s disease. Since the cells were autologous (in which the donor and recipient are the same person), there was no need for immunosuppression.

According to Dr. Michel Levesque, the lead author of the study and a physician at Cedars-Sinai Medical Center as well as the UCLA School of Medicine and the Brain Research Institute at UCLA, “We have documented the first successful adult neural stem cell transplantation to reverse the effects of Parkinson’s disease, and we have also demonstrated the long term safety and therapeutic effects of this approach.”

He adds, “Of particular note are the striking results this study yielded. For the 5 years following the procedure, the patient’s motor skills improved by over 80% for at least 36 months.”

Parkinson’s disease is a neurological disorder in which impaired neurons located within the substantia nigra region of the brain are no longer able to produce dopamine, the chemical that is necessary for natural muscle movement and coordination throughout the body. In the U.S. alone, approximately 1.5 million people have already been diagnosed with the disease and approximately 60,000 new cases of Parkinson’s disease are diagnosed each year. While Parkinson’s usually develops after the age of 65, approximately 15% of all people with the disease are under the age of 50. Conventional pharmacological treatments which attempt to replace or mimic dopamine may mask the symptoms of the disease, but none have been able to reverse the progression of the disease. Additionally, side effects, contraindications and other risks associated with such drugs are a serious concern.

Now, however, as Dr. Levesque has demonstrated, adult stem cell therapy offers the first type of treatment for Parkinson’s which actually reverses the progression of the disease, safely and effectively.

Presumably not yet aware of the medical scandal caused by the fetal stem cell therapy that resulted in the development of a tumor in an Israeli boy (see the related news article on this website entitled “Fetal Stem Cell Therapy Could Prove Fatal”, dated February 17, 2009), the authors of this study nevertheless felt it important to compare their autologous adult stem cell therapy with therapies that use fetal or embryonic tissue, which, the authors point out, “carry inherent risks of immunological reactions, infectious transmission and intractable dyskinesias, in addition to serious ethical concerns”, not to mention also the risk of tumor formation. By sharp contrast, autologous adult stem cell therapy does not pose any such risks, and thereby offers a new cellular therapeutic alternative to diseases of the central nervous system, especially for the selective neural repair of discrete cell loss in progressive degenerative diseases such as Parkinson’s.

As the authors conclude in their publication, “Adult neural stem cells derived from a patient’s cerebral tissue can become a source of differentiated neurons, useful for grafting in the treatment of Parkinson’s disease. The combined GABAergic and dopaminergic cells produced a long lasting motor improvement. This approach has the potential to make neural stem cell therapy acceptable and available to a large number of patients.”

For the average high school sophomore, learning to drive is a big deal. For 16-year-old Macie Morse, who just earned her learner’s permit and is now quite proficient behind the wheel of a car, the achievement is one that neither she nor anyone else in her family had ever thought would be possible. According to Macie, “It was one of the most exciting times of my entire 16 years.”

Having been born blind, until the age of 15 Macie had 20/4,000 vision in one eye and only light perception in the other eye. A visual score of 20/4,000 means that at a distance of 20 feet the person can see objects with as much clarity and visual acuity as the average person can see from a distance of 4,000 feet. The particular visual defect from which Macie suffered was optic nerve hypoplasia, which is an underdevelopment of the nerve that transmits visual signals from the eye to the brain. Unable even to read unless the print was within inches of her eye, Macie could only dream of participating fully in the world around her. As Macie puts it, “I’ve always wondered what it would be like to lay on the couch and watch TV. I always wondered what it would be like to see my friends.” According to Dr. James Thompson, optometrist and owner of Advanced Eye Care in Fort Collins, “If the optic nerve isn’t healthy, glasses aren’t going to do anything for anybody.”

Now, after having received adult stem cell therapy, Maci has 20/80 vision in one eye and 20/400 vision in the other, which is improved to 20/30 vision with a monocle.

Prior to Macie, only 10 other people had ever undergone the adult stem cell procedure for optic nerve hypoplasia, which costs $40,000, not counting travel expenses to and from the clinic in China where the therapy is administered. Raising money through a variety of sources throughout their local community, Macie and her mother were able to travel to China together so that Macie could have the therapy. Almost immediately, Macie showed dramatic improvement.

Legally, in order to be allowed to drive, one must have a minimum of 20/40 vision, a requirement which Macie now meets. According to her mother, “Before, I was always one step behind her, keeping an eye on her. Now I can let her be free. She’s going to be fine.”

Researchers have announced a new and somewhat surprising discovery with the novel population of extremely promising adult stem cells known as endometrial regenerative cells (ERCs). Already recognized for their highly angiogenic properties, ERCs are currently in development as a treatment for critical limb ischemia, which is an advanced form of peripheral artery disease. Now, in a counter-intuitive turn of events, ERCs have also demonstrated a strong ability to inhibit angiogenesis in tumor growth.

ERCs share certain similarities with mesenchymal stem cells while also exhibiting unique surface markers, and the cells are highly superior in a number of characteristics such as growth factor production, differentiability and expandability. In this latest study, researchers examined the ability of unmanipulated ERCs to influence gliomal growth in a Sprague Dawley rat model. A glioma is a type of cancer that arises from glial cells and is therefore most commonly found in the brain though also less often in the spine.

In a paper entitled, “Inhabition of Intracranial Glioma Growth by Endometrial Regenerative Cells”, the scientists found that ERCs inhibit the growth of these types of tumors. In fact, regardless of the route of administration, the ERCs were observed to induce dramatic inhibition of the glioma, with a 49% reduction in volume after intravenous administration of the ERCs and a 46% reduction in volume following intratumoral administration. In both cases, both an inhibition of angiogenesis as well as a reduction in the number of CD133+ cells were associated with the diminished intracranial tumor growth.

Such findings suggest a number of intriguing possibilities, such as, for example, an association between the strong anti-inflammatory properties of ERCs and the conceptual model of cancer in which tumor stem cells are thought to be triggered to enter the cell cycle as a result of cellular injury, which usually precipitates an inflammatory response. Although the precise molecular mechanisms underlying the behavior of ERCs have yet to be fully elucidated, they nevertheless offer a number of new and promising therapeutic modalities.

As the authors explain in their paper, “Despite the angiogenic potential of ERCs in the hindlimb ischemia model, these data support a paradoxical tumor inhibitory activity of ERCs. Further studies are needed to determine the qualitative differences between physiological angiogenesis, which seems to be supported by ERCs, and tumor angiogenesis which appeared to be inhibited.”

The embryonic stem cell company Geron is not allowed to enter the European market due to a questionable patent.

The European Patent Office has upheld an earlier decision to reject a patent application for the use of embryonic stem cells as filed by the Wisconsin Alumni Research Foundation in 1995. When Dr. James Thomson of the University of Wisconsin at Madison became the first person to isolate an embryonic stem cell in the late 1990s, much of his funding came from the Geron Corporation. Consequently, today Geron holds the worldwide license for the technology developed by Dr. Thomson and his colleagues.

In its response to the European Patent Office decision, Geron filed a form with the U.S. Securities and Exchange Commission (SEC) on Friday in which the company claims that “the applicability of this decision to such lines is uncertain.”

Geron has recently dominated the news because of the authorization that it has received from the U.S. FDA to begin the first clinical trials ever to be conducted with human embryonic stem cells. The clinical trials willl test the company’s product, known as GRNOPC1, which consists of live human embryonic stem cells, in the treatment of spinal cord injuries. The purpose of Phase I clinical trials is to test safety, whereas efficacy tests will be conducted later in subsequent clinical trials, assuming that safety can be proven, although this remains the subject of widespread speculation.

The SEC filing follows a secondary stock offering by the company on Thursday, at which time Geron conducted what investors are calling a “conveniently timed” public offering, after the close of the stock markets, of 7.25 million shares at $6.60 per share, significantly below Thursday’s closing price of $7.77 per share. The 12% discount grossed Geron approximately $43 million. Following the public offering, Geron is now in a goverment-mandated quiet period, during which time it is not allowed to speak to the press.

In the U.S., a number of unanswered questions remain in regard to Geron’s upcoming clinical trial. Geron will not even be able to begin enrolling patients in its small Phase I clinical trial until the summer of 2009, since the company has not yet received final clearance from the hospitals in which the trial will be conducted. Only ten patients will participate in the trial, but Geron is required to wait a full month between each patient due to the serious safety concerns that are associated with embryonic stem cells. Assuming that Geron will be able to enroll one patient per month – an assumption which has been questioned by many experts in the field – the study will not be fully enrolled until the middle of 2010 at the earliest. Additionally, since Geron must complete a full year of treatment for each patient, data will not be available until 2011. A number of investors have shorted Geron’s stock, having lost confidence in the company as a consequence of the years that it devoted to cancer vaccines and to telomerase-based drugs with no tangible results to show for the effort, two prime examples of which were Geron’s prostate cancer vaccine which dominated the news in 2003 and which has long since been buried and forgotten, in addition to Geron’s telomerase-inhibitor cancer drug known as GRN163L which seemed promising in 2007 and which temporarily drove up the stock price, but which ultimately yielded only disappointing data.

Geron’s stock plummeted 16.7%, or $1.30, to $6.47 during midday trading on Friday.