The U.S. company Neostem, which operates a number of adult stem cell collection centers, has signed an exclusive 10-year-long contract with Enhance Biomedical Holdings Limited (EBHL), the China-based subsidiary of Enhance Holding Corporation. The new agreement allows both companies to collaborate in the development of a network of adult stem cell collection and treatment centers in Taiwan and throughout a number of provinces in China.

According to the terms of the agreement, NeoStem will train EBHL staff in the proper implementation of the proprietary adult stem cell technology developed by NeoStem, for which EBHL has been granted the exclusive rights to utilize throughout Asia. In return, NeoStem will receive from EBHL a six-figure technical assistance fee, in addition to royalties on gross revenues and other associated fees over the 10-year period. The 10-year contract is renewable upon its completion.

As stated on their website, "NeoStem is the first company to provide adult stem cell collection and banking services to the general adult population. NeoStem’s medically proven process is a minimally invasive, painless and safe way to collect your own adult stem cells."

Since the U.S. FDA (Food and Drug Administration) has outlawed the use of autologous adult stem cell therapies in the U.S., an increasing number of U.S. adult stem cell companies are forced to take their business overseas. Only in the U.S. are each person’s own adult stem cells considered to be a "drug", according to the U.S. FDA, and as such, each person’s own adult stem cells are therefore subject to the same outdated and lethargic laws that regulate the pharmaceutical giants and other industrial manufacturers of medication. Consequently, 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. But now, U.S. citizens will be pleased to know that soon they will be able to add an entire new network of adult stem cell treatment centers throughout China to the growing list of foreign countries where adult stem cell therapies may be legally obtained.

In a new study which examines the cellular mechanisms that cause gray hair, scientists learn more about the mammalian aging process.

Cellular stress has long been known to accelerate aging, and more specifically it is the damage incurred by DNA which causes all the characteristics that are associated with advanced age. Now, scientists are one step closer to elucidating precisely what these various cellular and molecular mechanisms might be.

Led by Dr. Emi Nishimura, researchers at the Tokyo Medical and Dental University have examined the association between environmentally imposed chemical damage and graying hair. Graying hair is associated with aging not only in humans but also in other mammals, and is often the focus of cellular studies. In Dr. Nishimura’s experiment, laboratory mice were subjected to a variety of cellular assaults which included chemical injections and whole-body x-rays. The mice then began growing gray hair, which revealed permanent damage to the stem cells of their hair follicles upon analysis.

The cellular DNA of every living species is constantly under attack by damaging agents that include chemical pollutants, ultraviolet light and ionizing radiation, among others. A single mammalian cell can experience as many as 100,000 stressful "events" per day, any one of which would be enough to damage the cell’s DNA. This relentless assault throughout life by innumerable natural as well as manmade environmental stressors inevitably results in permanent damage to the DNA. The cummulative effects of this "DNA weathering" will eventually, beyond a certain point, become externally visible. When a certain amount of DNA damage is inflicted upon the stem cells of hair, graying is the resulting external sign.

Hair follicles contain stem cells which mature into melanocytes, which are the cells that produce melanin, which is the pigment that gives hair its color. These stem cells are especially vulnerable to cellular stress, however, which is why very few people make it to an advanced age without succumbing to gray hair. For the first couple decades of life, the stem cells in hair follicles are plentiful enough that there is simultaneously an abundance of those stem cells which differentiate into pigment cells, and those that merely reproduce into identical "daughter" stem cells. Consequently, pigment is continually being added to new, growing hair. But as the decades of life continue to accumulate, so do the cellular assaults, and an increasing percentage of the stem cells in the hair follicles will continue to mature until finally there are no more pigment cells left. Hair without pigment is gray.

In the past, the exact mechanisms by which the number of pigment cells in hair decreased were not fully elucidated, although DNA damage has been understood to play a key role. As Dr. Nishimura explains, the accelerated maturation of hair follicle stem cells may be the body’s "more sophisticated way" of purging the damaged stem cells, rather than just forcing the cells to die through more ordinary apoptotic (cellular death) mechanisms.

The topic of aging is a complex one, and it has implications for a number of medical and scientific fields, including not only stem cell therapies but cancer. How and why we age has always been a topic of general human interest. The exact mechanisms by which particular cells age, die, and either are or are not replaced by new cells, is of increasing scientific interest as well. Dr. Leonard Hayflick, the renowned cell biologist and founder of "molecular gerontology", played a key role in our understanding of these cellular mechanisms. By his discovery of the built-in limitations of cellular longevity, he established the fact that there exists a limit to the number of times that normal (noncancerous) cells can divide. This limit is known as the "Hayflick limit". While employed in cell biology and mycoplasmology at Wistar in the 1950s, Dr. Hayflick noticed that each cultured human and animal stem cell has a predetermined number of times that it can replicate in order to create another stem cell. Prior to his discovery of this, it had been commonly and erroneously believed for at least sixty years, since the turn of the previous century, that cells would continue to divide indefinitely. Dr. Hayflick discovered that cells stop growing after about 50 divisions, or population doublings. As he described, "They continued to eat, excrete waste, and perform all the metabolic housekeeping necessary to stay alive. They just didn’t replicate anymore. Eventually, debris attached to them, and they ultimately suffered ‘degeneration’." (From Stephen S. Hall, "Merchants of Immortality", 2003). It is now commonly understood that normal cells in culture have a finite limit to the number of times they can divide – unlike cancer cells, which are the only "immortal" cells, and can continue to divide indefinitely. But the discovery was initially a startling one. Together with Paul Moorhead, Dr. Hayflick published his revolutionary findings, which contradicted the current dogma of that era, first in Experimental Cell Research in 1961, and again in an updated version in Experimental Research, in 1965. Entitled, "The limited in vitro time of human diploid cell strains," this seminal paper introduced the new idea that the number of times a human cell is capable of dividing is innately limited. The paper had previously been rejected by the Journal of Experimental Medicine, and Dr. Hayflick still possesses the now famous rejection letter, in which the journal’s editor wrote, "The largest fact to have come out from tissue culture in the last fifty years is that cells inherently capable of multiplying will do so indefinitely if supplied with the right milieu in vitro." (Ibid.) Time will tell exactly how many other dogmatic pillars shall be overturned by future discoveries. Meanwhile, Dr. Hayflick’s discovery not only shattered conventional "wisdom", but it also focused attention on the cell as the fundamental location of aging. Dr. Hayflick was able to demonstrate for the first time that both mortal and immortal mammalian cells exist. Much of modern cancer and stem cell research today is based upon this distinction.

The cellular senescence (from the Latin, "senex", meaning "old man" or "old age"), or cellular death, discovered by Dr. Hayflick is now known to involve the successive shortening of chromosomal telomeres with each cell cycle as cells repeatedly divide. This feature of replicative cell senescence has become an established principle in biogerontology, the field of aging, although the exact mechanisms behind this process are still not yet fully understood. In addition to the successive shortening of telomeres, other factors in the process of DNA replication during cell division also contribute to "aging", such as cumulative DNA damage and mutation, as well as cross linkage. Despite the "Hayflick limit", however, it has also been shown that cells may be immortalized, thereby "crashing right through the Hayflick limit and continuing for dozens more cell doublings", by the extension of telomeres with telomerase. ("Hayflick Unlimited: Extension of Life Span by Introduction of Telomerase into Normal Human Cells." Science, 1997). In 1998, although it was somewhat disappointing as a commercial venture, the Geron Corporation developed techniques for extending telomeres, thereby demonstrating the ability of lengthened telomeres to prevent cellular senescence. Clearly, more work in this field will no doubt impact clinical applications of cancer and stem cell therapies.

Meanwhile, at least regarding the subject of gray hair, a number of interesting commercial and entrepreneurial opportunities continue to present themselves. Since it is virtually impossible to avoid DNA and stem cell damage throughout life, a global market exists for a procedure that would immortalize melanocytes, perhaps by extending the telomeres of these cells with telomerase. As Dr. Linzhau Cheng of the Johns Hopkins Institute of Cell Engineering has hypothesized, "We may soon have anti-graying creams for aging populations."

All three people have improved after receiving a new type of adult stem cell therapy for the treatment of blindness caused by corneal disease.

In an article entitled, "A Contact Lens-Based Technique for Expansion and Transplantation of Autologous Epithelial Progenitors for Ocular Surface Reconstruction", scientists in Australia describe a novel method by which sight has been restored to 3 people who were suffering from limbal stem cell deficiency (LSCD). A painful condition that can result in blindness, LSCD is caused by a depleted pool of endogenous adult stem cells which ordinarily exist to replenish the epithelium of the cornea on a continuous basis throughout life. Without such naturally occurring, endogenous adult stem cells, blindness inevitably results from the deterioration of the cornea. Led by Dr. Nick Di Girolamo, the team of doctors describe a novel technique by which autologous (in which the donor and recipient are the same person) adult stem cells were utilized to restore the eyesight in 3 people with advanced LSCD. One of the most innovative aspects of this procedure was not so much the use of the autologous adult stem cells, per se, but the use of an FDA-approved type of contact lens as the substrate for the stem cells.

Autologous progenitor cells harvested from limbal and conjunctival biopsies were expanded on contact lenses which were then surgically transferred to each patient’s corneal surface. The stem cells began attaching to the corneas immediately, and the natural lens of each eye was able to be surgically removed by 2 weeks after transplantation. During a follow-up period which lasted 8 to 13 months, the doctors found that "a stable transparent corneal epithelium was restored in each patient." Additionally, "There was no recurrence of conjunctivalization or corneal vascularization, and a significant improvement in symptom score occurred in all patients. Best-corrected visual acuity was increased in all eyes after the procedure." Two of the 3 patients were legally blind in one eye prior to the procedure, but following the therapy they can now read large letters on an eye chart. The third patient is able to read the top rows of the eye chart and has also passed a vision test for a driver’s license. All three patients continue to see with the new lenses.

According to ophthalmologist Dr. Peter McCluskey of Sydney University who is also director of the Save Sight Institute, "I think it’s really exciting, innovative and novel." As Dr. Di Girolamo adds, "We’re quietly excited. We don’t know yet if it will remain stable, but if it does it’s a wonderful technique. It’s simple and easy for the patient and you don’t need fancy equipment, just an ophthalmic surgeon and a lab for cell culture."

As the doctors concluded in their paper, "Ex vivo expansion of ocular surface epithelium in the presence of autologous serum and transplantation with the aid of a soft CL (contact lens) is a promising new technique capable of achieving ocular surface rehabilitation."

In the one-month period that transpired between April and May of this year, the National Institutes of Health received no less than 49,015 comments in response to the first draft of its new stem cell guidelines. The comments were submitted not only from people throughout the U.S. but also from people around the world who represent a broad spectrum of interests from the scientific and religious communities as well as from the public at large. NIH solicited and invited such comments, apparently thinking that matters which require a certain level of scientific expertise to understand can be decided democratically among the general public on the basis of majority vote. NIH did not disclose exactly how many of these nearly 50,000 comments were actually read, however.

As reported in Newsweek, "There has been something of a collective mood swing among stem cell scientists this year. Researchers were ebullient when President Obama lifted Bush-era restrictions on federal funding for embryonic stem cell research in March. But many were hugely disappointed when the NIH’s draft guidelines came out a month later." As has already been reported in related news articles on this website, one of the most hotly debated points in the new guidelines involves legalities of informed consent. As summarized in Newsweek, "Many of the (stem cell) lines developed from human embryos over the last decade would not meet these stringent new standards, and research using those cells would therefore be ineligible for government money." Among other organizations, the International Society for Stem Cell Research (ISSCR) stated in a letter to NIH that, "It is critical that a mechanism be developed to ensure that the past ten years of scientific progress with these lines not be lost to federally-funded research." (Please see the related news article on this website, entitled, "Embryonic Stem Cell Advocates Protest NIH Guidelines", dated May 25, 2009).

Another point of debate involves the procedure known as somatic cell nuclear transfer (SCNT), which can be used both for reproductive cloning as well as for so-called therapeutic cloning, neither of which are allowed under the new NIH guidelines although there are many scientists who wish to be able to use SCNT strictly for research purposes, despite the inherent risks.

Among the many religious groups who oppose embryonic stem cell research altogether and who advocate adult stem cell therapies instead, the United States Conference of Catholic Bishops also submitted a letter to NIH in which they stated their side of the argument. Unaffiliated with any religious group, however, are the many legitimate scientists and physicians who are already achieving great success with adult stem cells and who are eager to cite the many advantages of adult stem cells over embryonic stem cells, not for ethical or political reasons but purely for very concrete, scientific and medical reasons.

There remains one fundamental problem, however, which is rarely mentioned and which is therefore conspicuous by its absence in most debates over national stem cell policy in the United States. That problem has to do with the fact that the U.S. Food and Drug Administration (FDA) has insisted that the endogenous, autologous, naturally occurring adult stem cells, which are found in every human being’s body, should be classified as "drugs" and therefore must be regulated by the FDA and cannot be administered in any therapeutic manner, not even to the same person from whom the cells are derived, without first being subject to the same lengthy, lethargic, outdated approval process as a pharmaceutically manufactured drug, which is a process that typically takes a decade or longer and cost millions of dollars. This is the main reason why adult stem cell therapy is not available in the U.S. except to people who are accepted into a limited number of government-approved clinical trials, and this is precisely what is forcing legitimate adult stem cell physicians to relocate overseas, outside of the U.S., where even the most reputable and scientifically sound clinics must compete against the most disreputable and unscientific, and where it is not always easy for the patient-consumer to tell the two apart. A group of physicians, patients and other concerned citizens have formed a grass-roots advocacy movement in the U.S. in response to this grossly flawed stance by the FDA, and more info is available at www.safestemcells.org as well as at www.stemcelldocs.org. If it weren’t for the fact that each person’s own tissue and cells, which are found in each person’s own body, have been erroneously categorized as "drugs" by the FDA, subject to regulation and laws created by the FDA, then the numerous adult stem cell clinical therapies that have already been in use for years outside of the U.S. would also be available within the U.S., thereby rendering the debate over the hypothetical future clinical potential of embryonic stem cells irrelevant. (Please see the related news article on this website, entitled, "Two U.S. Adult Stem Cell Companies Form Collaboration in Asia", dated May 11, 2009).

Meanwhile, however, the debate rages on, with no realistic end in sight. Regardless of the details of the national stem cell policy which NIH is expected to unveil in its final form next month, however, there seems to be one point on which all parties can agree, which Newsweek summarized perfectly by stating, "Fireworks are expected one way or the other. Stay tuned."

In acute respiratory distress syndrome, inflammation and fibrosis result in loss of lung tissue which, according to a recent study, may be treated by mesenchymal stem cells.

Mesenchymal stem cells (MSCs) are known to produce a number of growth factors and have been shown to inhibit fibrosis in liver failure as demonstrated by Parekkaden et al. in 2007, and to differentiate into pulmonary cells as reported by Sueblinvong et al. in 2007. Additionally, bone marrow mononuclear cells, which contain both hematopoietic stem cells and MSCs, have been used to treat pulmonary hypertension in an animal model. Now, scientists have tested the therapeutic capacity of MSCs derived from Wharton’s Jelly in an animal model of lung fibrosis.

Led by Dr. Yuben Moodley, scientists in Australia have reported the results of their study in a paper entitled "Human Umbilical Cord Mesenchymal Stem Cells Reduce Fibrosis of Bleomycin-Induced Lung Injury". The scientists obtained Wharton’s jelly from human umbilical cords derived from full-term, live, healthy births, from which the mesenchymal stem cells (MSCs) were then separated and administered to a mouse model of bleomycin-induced lung injury. Lung tissue was evaluated at one, two and four weeks post-bleomycin, from which the researchers observed that the MSCs were found to have migrated only to those areas of inflammation and fibrosis but not to healthy tissue.

As the scientists describe in their paper, the administration of the MSCs reduced inflammation and inhibited the expression of various signaling chemicals which contribute to inflammation, including a number of proinflammatory cytokines. The scientists therefore concluded that MSCs "have antifibrotic properties and may augment lung repair if used to treat acute respiratory distress syndrome."

A glycopeptide antibiotic that is produced by the bacterium Streptomyces verticillus, bleomycin is commonly used in cancer chemotherapy but is well known for a number of serious side effects which include pulmonary fibrosis and other types of impaired lung function, due to the role of bleomycin in producing a number of proinflammatory cytokines and inducing oxygen toxicity.

Wharton’s jelly, named after the 17th century anatomist Thomas Wharton, is the gelatinous, mucosal substance found within the umbilical cord and is a rich source of hyaluronic acid, chondroitin sulfate and adult stem cells, among other substances.

In a letter to the editor of The Washington Post, Cynthia Cohen, Ph.D., J.D., Senior Research Fellow at the Kennedy Institute of Ethics at Georgetwon University in Washington, D.C., points out a few pros and cons of the recently proposed NIH guidelines.

Among other things, Dr. Cohen addresses "the grandfathering brouhaha", as she calls it, or in other words, "the storm raised by stem-cell scientists about the failure of the National Institutes of Health draft guidelines to grandfather in stem-cell lines already in use". Under the initial draft of the proposed NIH guidelines, certain conditions would render ineligible for federal funding many of embryonic stem cell lines that already exist, which has caused a loud uproar among embryonic stem cell scientists. (Please see the related news article on this website, entitled, "Embryonic Stem Cell Advocates Protest NIH Guidelines", dated May 25, 2009).

According to Dr. Cohen, she does not see this as an irreconcilable problem, but instead points out that, "The guidelines admirably add certain protections for those who make the difficult decision to donate, for stem-cell research, embyros remaining after in vitro fertilization treatment. Such protections did not appear in the Bush-era guidelines. While the protections complicate the informed-consent process, the grandfathering issue they raise can be remedied by adopting sections of the National Academy of Sciences guidelines addressing it."

Of greater concern, Dr. Cohen explains, "is that the NIH draft guidelines do not provide for oversight of stem-cell research at the institutional or national levels. In contrast, such oversight is called for by the National Academies, by the 2000 NIH stem-cell task force and by the 1999 report of the National Bioethics Advisory Commission." Having served as a member of Canada’s Stem Cell Oversight Committee, Dr. Cohen is speaking from personal experience when she points out that, "Oversight of stem-cell research has been generally appreciated by scientists in Canada, because it has enabled them to avoid ethical and policy pitfalls that could delay their research." Indeed, such a concept is hardlly new in the U.S., as Dr. Cohen cites the formal requirement of such oversight even in 1999 by the National Bioethics Advisory Commission which existed under the Clinton administration.

Although Dr. Cohen concedes that the NIH draft guidelines make "a good first stab" at addressing a variety of complex issues, she also points out that "these and other sorts of ethical and policy concerns will need to be addressed in the final NIH guidelines".

Dr. Cohen has written extensively on issues of medical bioethics over the years, including "The Interests of Egg Donors: Who is Deceiving Whom?" which was published in the Fall 2001 issue of The American Journal of Bioethics, "Creating Human-Nonhuman Chimeras: Of Mice and Men" which was published in the Summer 2003 issue of The American Journal of Bioethics, and her latest book, "Renewing the Stuff of Life – Stem Cells, Ethics, and Public Policy", which was published in 2007 by Oxford University Press.

Fate Therapuetics, located outside of San Diego in La Jolla, California, announced today that the first patient has been treated in a clinical trial for hematopoietic stem cell support. The Phase 1b study is testing FT1050, a proprietary small molecule stem cell modulator (SCM) which is being administered in a dual cord blood transplant for hematologic malignancy. Among other properties, FT1050 has been designed to activate specific pathways that determine the "fate" (the direction of differentiation and ultimate cell type, i.e.) of a stem cell, the purpose of which in this particular context is to increase hematopoietic stem cell number and function in the treatment of hematologic malignancies such as leukemia and lymphoma in adult patients who have undergone nonmyeloablative conditioning. The study is being conducted at the Dana-Farber Cancer Institute in Boston, where FT1050 is being administered during the standard course of dual umbilical cord blood transplants.

As Dr. Paul Grayson, president and CEO of Fate Therapeutics, explains, "The mission of Fate Therapeutics is to develop small molecules and biologics that modulate adult stem cells within the body for regenerative medicine. As our first SCM clinical candidate, FT1050 represents the initial step in our approach – using a small molecule to treat cells ex vivo but creating an in vivo regenerative effect. With FT1050, we are trying to affect stem cell biology in the body, improving the reconstitution of a patient’s blood and immune system."

According to Dr. Corey Cutler, assistant professor of medicine at Harvard Medical School and the director of the clinical study at Dana-Farber, "For patients who need hematopoietic stem cell support, time is of the essence. However, many patients do not have a suitably matched donor, either from a sibling or from an unrelated volunteer in the worldwide registries. Because umbilical cord blood units are readily available from cord blood banks, and the matching criteria for cord blood are less stringent than with adult donors, the ability to increase cord blood use by enhancing its efficiency has the potential to help thousands of patients waiting for a match." Twelve patients are expected to be enrolled in the trial for FT1050, which has been demonstrated to mediate not only stem cell differentiation pathways but also the ability of stem cells to "home in" on, and target, the bone marrow, thereby repopulating the patient’s own blood and immune system.

Patients with hematologic malignancies such as leukeia and lymphoma who do not respond to conventional therapies are often treated with intensive radiation, chemotherapy and additional forms of high-dose immunotherapy which often destroy the patient’s healthy blood and immunological systems in addition to the cancer cells. Bone marrow restoration through hematopoietic reconstitution is therefore necessary for the survival of such patients. In this as well as other types of clinical settings, adult stem cells obtained from umbilical cord blood have a number of therapeutic and logistical advantages over bone marrow or peripheral blood transplants, including but not limited to ease of matching HLA (human leukocyte antigen) markers as well as "faster availability, lower incidence and severity of acute graft-versus-host disease, lower risk of transmitting infections by latent viruses, lack of donor attrition and no risk to the donor", among other advantages, as described in the official press release of Fate Therapeutics. Additionally, as described on the company’s website, when compared to bone marrow and peripheral blood transplants, "cord blood is less immunogenic, which means it is less likely to be rejected by the patient’s immune system", and "cord blood is more readily available, which reduces medical costs and procedures necessary with obtaining stem cells from bone marrow or a patient’s or donor’s blood." Additionally, "cord blood has been used in hematopoietic stem cell support since 1988", and its safety and efficacy are well documented in the medical literature.

As also stated in the press release, "FT1050 was discovered by Leonard Zon, M.D., director of the Stem Cell Program at Children’s Hospital Boston and a scientific founder of Fate Therapeutics and is part of an exclusive license granted to Fate by Children’s Hospital Boston and Massachusetts General Hospital."

(Please see the related news article on this website, entitled, "Children’s Hospital of Boston and Fate Therapeutics Sign IP Deal", dated May 20, 2009).

In a strong sign of discontent, contrasting sharply with the enthusiasm that accompanied President Obama’s putative reversal of embryonic stem cell federal funding restrictions earlier this year, embryonic stem cell scientists have now concluded that Obama’s new policy would have the opposite effect and would instead impose new restrictions.

At the crux of the argument is the new set of guidelines proposed by the National Institutes of Health which would render ineligible for federal funding most of the current embryonic stem cell research that is already in progress and which is already receiving either federal or private funding. Contrary to popular misconception, the Bush administration did not forbid embryonic stem cell research altogether, and embryonic stem cell research has been alive and well throughout the U.S. for years, even predating the Bush administration. Now, however, under the Obama administration, the anticipated increase in the number of embryonic stem cell lines that would be eligible for federal funding is now instead jeopardized by new NIH guidelines which would actually decrease the number of eligible embryonic stem cell lines, thereby having the exact opposite effect of that which embryonic stem cell scientists had expected. In fact, under the new NIH guidelines, most of the embryonic stem cell research which is currently already in progress would suddenly be rendered ineligible and would have to be shut down.

According to Amy Comstock Rick, chief executive of the Coalition for the Advancement of Medical Research, "We’re very concerned. If they don’t change this, very little current research would be eligible. It’s a huge issue." As Dr. Lawrence Goldstein, director of the stem cell program at the University of California at San Diego, adds, "It’s not that past practices were shoddy. But they don’t necessarily meet every letter of the new guidelines moving forward. We’d have to throw everything out and start all over again."

One particularly contentious point in the new NIH guidelines pertains to issues of informed consent. Couples who donate their embryos for research would now be required to sign a consent form acknowledging that they were fully informed of other options, such as the possibility of donating their embryos to other couples for the purpose of allowing the embryos to grow and be born as children. Currently, not all IVF (in vitro fertilization) clinics present such options to couples, and those clinics which do discuss such options with their clients do not always have the information specified in writing.

As Dr. George Daley of the Harvard Stem Cell Institute explains, "They take 2009 standards and attempt to apply them retroactively, which isn’t really a standard that would allow most of the preexisting lines to be acceptable for NIH funding. This is essentially moving the goal post."

According to Dr. Patrick Taylor, deputy counsel of Children’s Hospital in Boston, whose critique of the proposed NIH guidelines appeared last month in the journal Cell Stem Cell, "If applied retroactively, the proposed guidelines would render ineligible most stem cell lines."

Raynard Kington, acting director of the NIH, declined further comment other than to state, "We know issues like this, among many issues, have been raised, and we will take them into consideration."

NIH published their first proposed draft of the new guidelines on April 17. The final version is expected to be released by July 7.

(Please see the following related news articles on this website: "NIH Issues Guidelines Restricting Embryonic Stem Cell Research", dated April 17, 2009; "Members of The President’s Council on Bioethics Object to Obama’s Stem Cell Policy", dated March 26, 2009; "A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama’s Policy", dated March 13, 2009; "Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research", dated March 11, 2009; "Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research", dated March 10, 2009; "Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect", dated March 9, 2009; and "Former Director of N.I.H. Explains Why Embryonic Stem Cells are Obsolete", dated March 4, 2009).