Ordinary Skin Cells are Reprogrammed to Beat as Heart Cells

Their rhythmic beating clearly visible, just in time for Valentine’s Day, the iPS (induced pluripotent stem) cells exhibit all the characteristics of cardiac cells, even from within their laboratory dish. These cardiac cells were not differentiated from embryonic stem cells, however, nor from any type of stem cell, but instead they were obtained by the reprogramming of ordinary, fully mature and differentiated adult skin cells. Since cardiac cells are among the most specialized of all cell types within the human body, such a dramatic demonstration is visible proof, at least in principle, of the ability of iPS cells to differentiate into virtually any type of bodily tissue.

According to Dr. Tim Kamp, a cell biologist who holds titles of associate professor in both medicine and physiology at the University of Wisconsin at Madison, and who led the study, “This is the first demonstration that human induced cells can form different types of heart cells in a dish. We didn’t know whether they could form heart cells efficiently. But they successfully formed heart cells with all the electrical and organizational properties we’d expect.”

Contrary to popular misconception, however, iPS cells won’t be available any time soon at your local neighborhood doctor’s office. The genetic reprogramming that is involved in reverting an ordinary mature skin cell into a more primitive cell, that merely resembles a stem cell, is still too dangerous to be used as a clinical therapy in real people. Among other problems, there is still a high risk of tumor formation from the genetic mutations that are required for reprogramming of the cells, not to mention also biological contamination and other unresolved difficulties, so scientists still have a long road ahead of them before such “technicalities” can be overcome.

Nevertheless, this demonstration adds yet one more example to the growing list of cell types that have been obtained without the use of embryonic stem cells, and which therefore circumvent at least the contentious ethical controversies, if not also the unsolved scientific problems and medical risks, associated with embryonic stem cells.

Osiris Demonstrates Exceptional Performance of Adult Stem Cell Product in Clinical Trial

The company Osiris Therapeutics, which is focused exclusively on the development of adult stem cell therapies, not embryonic stem cell therapies, today reported the final data from its two-year-long Phase I clinical trial in which one of its adult stem cell products, Prochymal, was evaluated for safety and preliminary efficacy in the treatment of heart attack. The double-blind, placebo-controlled study consisted of 53 participants who had suffered acute myocardial infarction (MI), all of whom were fully immunocompetent patients, and none of whom exhibited any signs of adverse immune response or infusional toxicities from the Prochymal. In fact, Prochymal demonstrated even greater safety than a placebo, since the patients who received the placebo instead of Prochymal exhibited a higher rate of adverse events. For the patients who received Prochymal instead of a placebo, Prochymal resulted in the improvement of a number of parameters including a drop in repeat hospitalizations as well as significant improvement in cardiac function and reduced incidents of cardiac arrhythmia. Not only did the clinical trial met its primary endpoint for demonstrating the safety of Prochymal in an acute MI setting, but in all aspects Prochymal has exhibited an extremely favorable safety profile. Additionally, experts describe the procedure as being so simple that even community hospitals could easily adopt the protocol.

Data from this ground-breaking adult stem cell therapeutic product indicate that Prochymal does indeed expedite patient recovery from heart trauma, which previously has always been extremely difficult to treat with much success. According to the president and CEO of Osiris Therapeutics, Dr. C. Randall Mills, “This study adds convincing long-term data to the excellent safety profile of Prochymal, having now treated hundreds of patients in trials over the past decade. We are excited that Prochymal demonstrated strong evidence of efficacy beyond the best cardiac care available today. We are now advancing this program into a larger Phase II trial, focusing on patients with more severe heart damage.”

Osiris is developing its Prochymal therapy in collaboration with Genzyme, with whom Osiris formed a strategic alliance last year for the development and commercialization of Prochymal, and for which enrollment was recently completed in a Phase III clinical trial for the treatment of steroid-refractory acute graft-versus-host disease. Additionally, in January Osiris received FDA approval to broaden its expanded access program for Prochymal, which is a proprietary preparation of mesenchymal stem cells that are derived from the bone marrow of healthy adult donors and specifically formulated for intravenous infusion.

According to Dr. Timothy Henry, director of research at the Minneapolis Heart Institue Foundation at Abbott Northwestern, “This placebo-controlled study was truly the first of its kind and the data produced are promising. It clearly suggests that allogeneic adult stem cells have significant potential to improve recovery following a heart attack and can prevent long-term adverse effects. Given the fact that we can administer this drug through a standard I.V. in an acute setting, Prochymal could become an integral part of standard-of-care for the treatment of heart attacks everywhere.”

Osiris is focused on the treatment of a variety of inflammatory, orthopedic and cardiovascular diseases. As described on their website, “Prochymal is currently being evaluated in Phase III trials for steroid refractory GvHD, acute GvHD, and Crohn’s disease. Prochymal has been granted Fast Track status by the FDA for all three of these indications. Prochymal also obtained Orphan Drug status by the FDA and the European Medicines Agency for GvHD. Prochymal is being studied in Phase II trials for the treatment of COPD (chronic obstructive pulmonary disease), type 1 diabetes, and acute myocardial infarction. Additionally, the U.S. Depaartment of Defense recently awarded Osiris a contract to develop Prochymal as a treatment for acute radiation syndrome.”

Osiris Therapeutics is the leading stem cell therapeutic company in the world, involved in the research and development of therapeutic products that are based exclusively upon adult stem cells, not embryonic stem cells.

Multiple Sclerosis Successfully Treated Yet Again With Adult Stem Cells

After participating in a small clinical trial at Northwestern University, Edwin McClure seems to have recovered from multiple sclerosis (MS). Conducted on 21 participants and led by Dr. Richard Burt, the clinical trial involved treating the MS patients with their own adult stem cells. The only drawback of the study, however, was the use of chemotherapy to destroy each patient’s immune system prior to the adult stem cell therapy. Nevertheless, patients such as Mr. McClure have shown dramatic improvement.

Diagnosed with MS four years ago at the age of 18, Edwin McClure underwent a regimen of conventional MS medication but without any results. According to Mr. McClure, “I would get fatigued. I couldn’t deal with the heat. I had really bad balance.” Then he heard about the trial being conducted at Northwestern University in Chicago, and decided to participate. Now, he says, “I really don’t feel like I have multiple sclerosis anymore.” In regard to the chemotherapy, however, he adds, “It was rough.”

Approximately 400,000 people in the U.S. and 2.5 million people globally are estimated to suffer from MS, which is a degenerative, autoimmune, demyelinating disease of the central nervous system, the precise causes of which remain unknown, and a precise cure for which has not previously existed. According to Dr. Burt, however, “Well now for the first time in battling MS, I think you can say there’s a study that’s shown we’ve turned the tide against the disease.”

In actuality, other doctors have already had success in treating patients with multiple sclerosis, but without the brutal and deliberate destruction of the immune system with radiation. As previously reported on this website, prior to receiving the autologous stem cell transplantation in the clinical trial led by Dr. Burt, each patient also underwent immunological myeloablation, in which radiation is employed to destroy the patient’s immune system. While such a procedure had previously been considered a necessary part of the therapy, even though it exposes the patient to potentially life-threatening risks, today an increasing number of doctors are questioning the logic and necessity of subjecting their patients to deliberate immune destruction, and with valid scientific reason. In a publication that appeared over two years ago, in the Journal of Translational Medicine in January of 2007, Dr. Neil H. Riordan et al. posed the following question: “…in patients who are not suffering from a disease that is associated with an aberrant bone marrow such as hematological malignancies or immunological dysfunctions, how is it justifiable to subject them to the high levels of morbidity and mortality associated with immune suppression?” Dr. Riordan and his team of scientists then examined compelling evidence which strongly indicates that pre-transplant immune suppression is unnecessary for many types of autologous hematopoietic cell therapies and even for some allogeneic therapies that utilize “universal donor” cells such as mesenchymal stem cells and the CD34+ stem cells that are found in umbilical cord blood, and for which immune rejection is not even a concern. As Dr. Riordan and his colleagues wrote in their 2007 paper in a section that is subtitled, “Mesenchymal stem cells do not need myeloablation for efficacy”: “Currently there are several ongoing clinical trials in Phase I-III using ‘universal donor’ mesenchymal stem cells in non-conditioned recipients of Crohn’s disease, GVHD (graft-versus-host disease) and myocardial infarction. Although these cells are bone marrow expanded mesenchymal cells, the superior proliferative potential of cord blood mesenchymal cells may allow them not only to escape immune destruction, but also to expand in vivo and mediate therapeutic effects superior to those derived from bone marrow. The fact that regulatory agencies have allowed advancement of ‘off-the-shelf’ universal donor mesenchymal stem cells supports the numerous reports of clinical efficacy in an allogeneic setting.”

Nevertheless, for clinical trials such as those conducted by Dr. Burt at Northwestern University, the adult stem cell therapy offers tangible improvement – at least for those patients who survive the life-threatening destruction of their immune systems from radiation. One can only conclude, therefore, as has already been demonstrated by other doctors at other clinics, that patients would exhibit even greater and faster improvement if they did not have to recover from the deliberate destruction of their immune systems prior to receiving the stem cell therapy, and also if the stem cell therapy would utilize the “superior proliferative potential” of the “immune privileged” adult stem cells that are found in umbilical cord blood.

Edwin McClure and his mother, Bernice, were featured today on the Early Show with CBS television correspondent Debbye Turner Bell.

The Stem Cell Revolution

The February 9th, 2009 issue of Time Magazine features a cover story entitled, “How the Coming Revolution in Stem Cells Could Save Your Life.” Plastered across the magazine’s front cover is a photograph of a colorful pink and blue blob which is identified as an “induced pluripotent stem cell from an ALS (amyotrophic lateral sclerosis) patient.”

Not surprisingly, this is not the first time that the topic of stem cells has been chosen for the cover of Time Magazine. Among their numerous articles on the subject and its related personalities over the years, Time Magazine also featured a cover story about stem cells in the August 7th, 2006 issue, entitled, “The Truth About Stem Cells: The Hope, The Hype, and What it Means For You”. At that time, plastered across the front cover of the magazine was a microscopic enlargement of a pink and green blob which was identified as an “adult bone marrow stem cell”. The 2006 cover story was ten pages long, 9 pages of which contained text; by comparison, this year’s cover story is only 6 pages long, a mere 5 pages of which contain text. Given the rapid pace of advancements that have transpired in the stem cell field over the past 3 years, one might logically expect a recent article on the topic to be at least as long as, if not even longer than, an article that was written 3 years ago; and perhaps the 2009 article might have been longer than it is, had the author thought to include the topic of adult stem cells. But, for whatever reason, and unlike the 2006 article, the 2009 article is instead devoted exclusively to the topic of everything else but adult stem cells.

In the 2006 article, the reader’s eye was immediately drawn to a two-page illustration of stem cells stretching across pages 42 and 43 of the issue, which is strikingly similar to the two-page illustration that also stretches across pages 42 and 43 of the 2009 issue. As in the 2006 issue, as one might expect, the co-director of Harvard’s Stem Cell Institute, Dr. Douglas Melton, is also extensively interviewed in the 2009 issue. Unlike the 2006 issue, however, the 2009 issue is devoted exclusively to descriptions of research with embryonic stem cells and iPS (induced pluripotent stem) cells, with practically no mention whatsoever of adult stem cells nor of the extraordinary progress that has already been achieved with adult stem cell therapies. In fact, rather than being a scientifically objective presentation of the pros and cons of various types of stem cells, the 2009 article appears to be more along the lines of either a personal biographical tribute to Douglas Melton, or a form of retribution directed against “the dark days of the Bush Administration’s stem-cell restrictions”, or both. But balanced and unbiased, it is not.

Indeed, the 2009 Time Magazine cover story points out, in reference to Dr. Melton’s work, that “Melton’s motivation was, again, both professional and intensely personal,” since this distinguished scientist has two children who suffer from type 1 diabetes: a son who was diagnosed with the disease 17 years ago at the age of 6 months, and a daughter who was also diagnosed with type 1 diabetes 8 years ago at the age of 14. Certainly, no reader would question the relevance nor the importance of personal experiences such as these, which were highly influential in changing the entire direction of Dr. Melton’s career. One does, however, question how it is possible that, in any article which claims to inform readers about a “coming revolution in stem cells” which might “save your life”, the author of the article could systematically avoid all mention of adult stem cell therapies which already exist and which have already been saving lives in clinics around the world. Instead, in an article which purports to inform readers about medical therapies which are so urgently and desperately needed by so many people, not only by Dr. Melton’s children, the author of this article chooses only to feature embryonic stem cells and iPS (induced pluripotent stem) cells, which do not exist at all as therapies. Indeed, the safety and efficacy of embryonic and iPS cells are so questionable that it might be another decade or longer before such cells can be used as clinical therapies, assuming that they can ever be safely and effectively used as clinical therapies at all. And yet, in this article, embryonic stem cells and iPS cells are inaccurately presented as the only possible source of future stem cell therapies for people who are suffering from disease and injury. Perhaps adult stem cells were entirely and mysteriously excluded from this article because adult stem cells do not represent a “coming revolution” but instead represent a current revolution that has already arrived and is already fully upon us and is already taking place at this very moment, in the here-and-now, on a global basis, if anyone would care to notice. By sharp contrast to adult stem cells, however, the therapeutic viability of embryonic stem cells and even of iPS cells is still entirely hypothetical and no one can predict with any certainty when, if ever, embryonic or iPS cells might be available as clinical therapies, but even the most determined of embryonic stem cell experts do not expect embryonic stem cell nor iPS cell therapies to be available in less than a decade.

If there are any dangers that are associated with adult stem cells, or if there had ever been any problems that were ever found with the numerous FDA-approved clinical trials that have already been conducted with adult stem cells, then this would have been the place to highlight and feature such dangers and problems; but instead, the entire topic of adult stem cells is categorically ignored altogether throughout this 2009 Time Magazine cover story. Nowhere to be found at all, adult stem cell therapies are conspicuous by their absence from the whole article. Of course, the numerous clinical applications of adult stem cells have only yielded dramatic successes, not failures, but apparently the purpose of this article was not to inform the public of successful medical breakthroughs that have already occurred. Instead, the purpose of this article seems to have been to inflate public hopes and expectations for future medical breakthroughs that might not ever occur. Oddly enough, however, the author of this 2009 Time Magazine article does acknowledge some, though not all, of the dangers associated with embronic and other types of pluripotent stem cells, as the author clearly states, “Even iPS cells have yet to prove that they are a safe and suitable substitute for the diseased cells they might eventually replace in a patient. Ensuring their safety would require doing away with dangerous genes that can also cause cancer, as well as the retroviral carriers that Yamanaka [the discoverer of iPS cells] originally used.” But nowhere in this article are teratomas ever mentioned, despite the fact that the ability of an embryonic stem cell, and an iPS cell, to form this particularly hideous and dangerous type of tumor is, by definition, one of the requirements by which embryonic and iPS and other types of pluripotent stem cells are identified in laboratories throughout the world. Interestingly, the author makes reference to Geron’s highly publicized upcoming clinical trial with human embryonic stem cells – the first of its kind, and the first ever to attain approval from the U.S. FDA – without actually mentioning the Geron Corporation by name, and also without ever mentioning any of the problems that are inherent in this clinical trial. (Please see the related news article on this website entitled “Geron’s Efforts in Europe are Thwarted”, dated February 13, 2009). Geron’s clinical trial has not even begun patient enrollment yet, and data from the Phase I trial will not even be available until 2011 at the earliest, yet nevertheless this clinical trial was deemed worthy of mention in the article, even though, for whatever reason, the name of the Geron Corporation itself was not; however, nowhere in the article is there any mention whatsoever of any of the adult stem cell companies that have already conducted FDA-approved clinical trials with adult stem cells, such as, most obviously, Osiris Therapeutics, which is already legendary within the scientific community for its pioneering work and repeated, consistent success with its adult stem cell therapies in a number of FDA-approved clinical trials that have already advanced to Phase III. Of course, the fact that Osiris Therapeutics is never mentioned even once in this article would, presumably, have nothing to do with the fact that Osiris Therapeutics is strictly an adult stem cell company, the exclusive focus of which is the development of clinical therapies from adult stem cells, not from embryonic stem cells. Certainly, members of the media would never be biased against adult stem cell companies; instead, we can only give members of the media the benefit of the doubt by magnanimously concluding that they simply don’t understand the scientific and medical differences between these various types of stem cells and stem cell companies, because if they did understand the differences, they would be blowing trumpets from the rooftops of their buildings in excitement over the revolutionary life-saving successes that have already been achieved with adult stem cells.

Some statements within the 2009 Time Magazine article are fundamentally inexplicable, and leave anyone with a true scientific understanding of stem cells scratching his or her head, such as the statement that, “…embryonic stem cells remain the gold standard for any treatments that find their way into the clinic…”, which is a puzzling cliam, to say the least, especially in light of the fact that embryonic stem cells have never advanced to any type of treatment that has ever found its way into the clinic at all. The only type of “gold standard” with which embryonic stem cells are associated is their ability to form the specific type of tumor known as a teratoma, which literally is the “gold standard” by which laboratories around the world identify embryonic and iPS and all other types of pluripotent cells, since the ability to form a teratoma is part of the official scientific definition of pluripotency. Don’t expect to find any mention of teratomas, however, in this article, nor a fairly representative reporting of scientific discoveries and advancements in the stem cell field, since such facts and perspectives are not to be found here. Regarding “treatments that find their way into the clinic”, only adult stem cells, not embryonic stem cells, have ever advanced to the level of actual therapies that have ever found their way into the clinic, yet this fact is never mentioned, not even once, in this entire 2009 Time Magazine article; to the contrary, there seems to be a concerted effort made throughout this article to create the exact opposite, and entirely erroneous, impression.

Of course, the 2006 Time Magazine cover story on stem cells was not without its inaccuracies either. In that issue, in a small side-paragraph entitled “umbilical-cord cells”, under the subheading “Drawbacks”, the author wrote, “An umbilical cord is not very long and doesn’t hold enough cells to treat an adult.” If sentences such as this don’t leave legitimate stem cell scientists cross-eyed and scratching their heads, nothing will, and the most common reaction among scientists that this type of statement most frequently evokes is a simple, “huh?” Apparently, the author of the 2006 Time Magazine cover story had never heard of cell isolation or expansion – even without which, umbilical cord blood is still one of the most plentiful and overly-abundant sources of adult stem cells in the world, being freely and easily accessible everywhere throughout the world, on a daily basis, to such an extent that at any given moment we actually have much more than we could ever possibly use, even if we wanted to treat the entire population of the planet. Even the adult stem cells known as ERCs (endometrial regenerative cells), which are collected in even smaller volumes than umbilical cord blood, are expandable to quantities that outnumber the human population of the planet. Furthermore, given the numerous chemical, molecular and immunological properties of adult stem cells derived from umbilical cord blood, all of which are highly advantageous properties, it is laughable to cite the physical length of an umbilical cord as a “drawback”. But of course, journalists are not usually scientists, and therefore should not be expected to think and reason as scientists do, even though journalists have taken upon themselves the very serious responsibility of reporting scientific news, presumably in an accurate and truthful manner. It could hardly be considered complex science to make the simple observation that children are born every day throughout the entire world, and therefore umbilical cord blood is abundantly available every day throughout the entire world; yet somehow, in an article that was published in 2006 in one of the leading and most trusted magazines in the world, even this simple and obvious fact was lost and obscured by an irrelevant and scientifically false comment.

If anyone really cared about helping the people who suffer from disease and injury and who could benefit from stem cell therapy, and who are in fact in desperate and urgent need of such therapy, would it not seem reasonable at least to mention the FDA-approved clinical trials and actual clinical successes that have already been achieved with adult stem cells? Especially among scientists and journalists, how is it conscienable to completely, categorically, systematically ignore even the mere mention of adult stem cell therapies, when there are numerous people for whom such adult stem cell therapies could literally make the difference between life and death?

At least the 2006 article did mention that adult stem cells “exist in many major tissues, including the blood, skin and brain. They can be coaxed to produce more cells of a specific lineage and do not have to be extracted from embryos.” Strangely, the 2009 article fails to mention even this basic fact. The 2006 article did, despite its other flaws, at least point out that umbilical cords are “useful” because, according to the author, “Although they are primarily made up of blood stem cells, they also contain stem cells that can turn into bone, cartilage, heart muscle and brain and liver tissue. Like adult stem cells, they are harvested without the need for embryos.” By comparison, the 2009 article makes no mention whatsoever of umbilical cord blood at all, nor, in fact, is there any mention whatsoever of adult stem cell therapies, period. There is barely any mention of the fact that there is such a thing as adult stem cells and that they exist at all. In a semantically ambiguous phrasing of words, there is a reference in the 2009 article to stem cells that “can be created from adult cells”, which is stated in a partial sentence that hangs in mid-air next to an illustration of an “egg cell” in which somatic cell nuclear transfer, “genetic transfer” with retroviruses and four genes, and “safer transfer” with “chemicals or safer viruses”, are symbolically depicted. Of course, stem cells that are “created from adult cells” are not the same as “adult stem cells”, since the former (referring to iPS cells and to those other types of cells that are created by somatic cell nuclear transfer, “genetic transfer” and “safer transfer”, whatever exactly that will turn out to be) still pose a number of risks including tumor formation, whereas the latter (adult stem cells) do not pose any such risks, which is precisely why the former do not exist as clinical therapies whereas the latter (adult stem cells) do; but exactly how the non-scientific reader would ever be able to deduce such facts from this article is anyone’s guess. If nothing else, at least the adult stem cells known as mesenchymal stem cells, which are derivable from bone marrow as well as umbilical cord blood, could have been mentioned somewhere in this article, since these cells have already enjoyed a very well documented clinical history for decades. But alas, apparently even mesenchymal stem cells were forbidden from enjoying the right to “equal opportunity” in this article. The mere title of this cover story, “How the Coming Revolution in Stem Cells Could Save Your Life”, might logically imply some mention of the types of stem cells that have already saved lives, and which have already achieved a revolution in medical science; and those types of stem cells are adult, not embryonic, stem cells. Instead, perhaps the cover of this particular issue of Time Magazine could have been more accurately entitled, “How the Dangerous and Problematic Embryonic and iPS Cells Might Never Be Developed into Therapies That Could Save Your Life.”

If nothing else, the most recent, 2009 Time Magazine cover story does manage to offer resounding proof of an explanation for one long-standing mystery, which is, namely, why the general public is usually so confused about stem cells. Without objective and balanced scientific reporting, especially from the most established and respected names in the media, of course the average non-scientific lay person cannot be expected to understand even the most fundamental of scientific facts and principles behind any particular issue. In a few more years, perhaps some time around 2012 or so, maybe Time Magazine might publish yet another cover story about stem cells, by which time perhaps the publishing powers-that-be might not completely and deliberately ignore the increasing number of successes that are being achieved every day with adult stem cells, nor the increasing number of dangers and risks that are inextricably linked to embryonic stem cells and to iPS cells. Perhaps it will take a few more years before it is once again “politically correct” even to mention the topic of adult stem cell therapies, and thereby to publish a scientifically objective article about a critically important scientific field. The very same people who accuse the previous Administration of using politics and ideology instead of science to dictate policy, are in fact now guilty themselves of the very same thing, as they attempt to impose their own personal biases and prejudices upon others through the exact same fatally flawed approach. Hopefully, at some time in the future, perhaps both sides of the great political and ethical divide might be able to agree upon the same scientific facts; but how many people will die in the next few years, as they patiently wait for the media to get around to reporting accurately and truthfully about medical therapies with adult stem cells that already exist and are already available?

One thing is certain, though, as Dr. David Scadden, co-director of the Harvard Stem Cell Institute, is quoted as saying in the 2009 Time Magazine article: “It’s a wonderful time [for the stem-cell field]. Keep your seat belt on, because this ride is going to be wild.” At the very least, no one can argue with that claim.

South Korea Delays Decision on Cloning

Just as it was about to issue a long-awaited decision, the National Bioethics Committee of South Korea has decided to delay its decision over whether or not to allow the Seoul-based CHA Medical Center to proceed with research that involves human cloning.

Stem cell scientists throughout the world still recall the scandal that developed as a result of Dr. Hwang Woo-suk’s claims in 2005 that he had created cloned human embryos from human embryonic stem cells, only to discover by 2006 that such claims were fraudulent, even by Dr. Hwang’s own admission, at which time Dr. Hwang was fired from his research position at the Seoul National University and banned by the National Bioethics Committee from continuing his work. Consequently, ever since 2006, all research on cloned human embryos has been officially halted in South Korea.

Entirely independent of Dr. Hwang, the CHA Medical Center had applied for authorization to conduct somatic cell nuclear transfer, the same technique that was used to create Dolly the Sheep in 1996. Unlike with Dolly the Sheep, however, the CHA Medical Center had hoped to be able to conduct somatic cell nuclear transfer for purposes of so-called therapeutic cloning, even though it is the exact same technique that is used in reproductive cloning. From the embryonic stem cells that would be created by the cloned human embryos, scientists would then hope to be able to conduct research for the development of medical therapies.

Proponents of therapeutic cloning claim that it would allow for patient-specific stem cell therapies without the risk of immune rejection. However, critics of the method point out that patient-specific stem cell therapies without the risk of immune rejection already exist, and in fact have already been developed from adult stem cells and are already being used to treat patients in clinics around the world. Similarly, immune-privileged “universal donor” stem cells, which have no risk of immune rejection and which offer a viable alternative to patient-specific therapies, have also already been developed from adult stem cells and are also already being used as successful therapies in clinics around the world. Such adult stem cell therapies do not pose any of the numerous risks that embryonic stem cells pose, not the least of which is the risk of teratoma (tumor) formation, which is, by definition the primary requirement by which embryonic and all other pluripotent stem cells are identified. Contrary to popular misconception, there are a number of valid scientific and medical reasons for avoiding embryonic stem cells, and these reasons are entirely separate from the ethical, religious and political controversies that remain inextricably entangled in the deliberate destruction of human embryos. Ethics and politics aside, embryonic stem cells remain highly problematic in the laboratory purely for scientific reasons, which is why they have never advanced to the clinical stage. By sharp contrast, however, adult stem cells behave very differently from embryonic stem cells, which is why so many different types of adult stem cells have already been successfully developed into clinical therapies, whereas embryonic stem cells never have.

In delaying its verdict, the National Bioethics Committee of South Korea has required the CHA Medical Center to submit a more detailed proposal for its research. In turn, the CHA Medical Center intends to reapply in two or three months.

Healthcare Conglomerate Buys Adult Stem Cell Company in $100 Million Acquisition

The California-based conglomerate Healthcare of Today has announced its acquisition of the Houston-based biotech company Regenetech for $100 million. Among Regenetech’s several hundred patents and patent applications throughout the world are 13 patents licensed from NASA for the expansion of adult stem cells in the type of microgravity environment that exists throughout interstellar space.

According to the CEO of Healthcare of Today, Henry Jan, “Regenetech’s work is astounding. We are thrilled to bring a leader in adult stem cell technology into the family of Healthcare of Today companies. Our mission has always been to provide the highest levels of healthcare to our clients, and a company whose passion is to do this through biotechnology is a natural fit for us.”

Founded in May of 2008 and headquartered in Burbank, California, Healthcare of Today is a holding company, the primary focus of which is the acquisition and development of diverse types of corporations within the healthcare industry. The Regenetech acquisition is merely the latest in a series of acquisitions made by Healthcare of Today, which in recent weeks has also made other corporate purchases of similar size and significance. Through its various subsidiaries, Healthcare of Today owns a number of pharmaceutical, insurance, assisted living, senior communities, nurse staffing, real estate brokerage and biotechnology businesses.

Regenetech, which boasts at least one NASA astronaut among the members of its scientific advisory board, is a leader in the R&D of adult stem cells. In September of 2008, Regenetech entered into a technology and patent licensing agreement with Biogenea-Cellgenea of Greece for the development of adult stem cell therapies in the treatment of cardiovascular, hematological and neurological diseases including Parkinson’s disease, Alzheimer’s disease and spinal cord injuries.

According to their website, Regenetech “develops and offers intellectual property licenses in the area of adult stem cell expansion and therapeutic applications of adult stem cells. Regenetech uses a technology discovered by NASA in space experiments for growing three-dimensional (3D) stem cells in a weightless environment. Regenetech’s research results indicate that adult stem cells can be harvested from a filtered extraction of the patient’s own blood and grown to larger, therapeutic quantities eliminating the most critical problem in conventional adult stem cell therapies: availability of adult stem cells rapidly, safely, and at reasonable cost. This minimally invasive procedure reintroduces the patient’s own stem cells to provide red and white blood cells, platelets, and connective tissues. Regenetech has the exclusive rights to thirteen patents originally issued to NASA. The company has added to the original technology licensed from NASA through its own technology creation program and has to date filed applications for over 200 patents of its own with additional patent applications targeted.”

Scientists Unlock the Mystery Behind Cancer Stem Cell Radiation Resistance

It has long been well known that ordinary cells throughout the body are easily damaged by radiation, while cancer cells are not. For this reason, cancer patients who undergo radiation therapy often suffer from the destruction of their healthy tissue, whether or not the radiation is also successful in destroying the cancer cells. Radiation is not always successful in destroying cancer cells, however, and the reasons behind this fact have remained elusive, until now.

In collaboration with the City of Hope National Medical Center, researchers at the Stanford University School of Medicine have found a possible solution to this problem. Studying breast epithelial stem cells from humans and mice, the scientists discovered a “protective pathway” that shields normal stem cells from DNA damage. Unfortunately, this molecular defense mechanism is also a characteristic of some types of cancer stem cells; fortunately, however, when this pathway is blocked, the cells become more susceptible to radiation.

The protective pathway consists of the increased expression of proteins that bind and deactivate the various types of reactive oxygen species (ROS) which damage DNA. The scientists found that normal stem cells, such as stem cells of blood and breast epithelial origin, have lower levels of ROS than do regular cells which are not stem cells. Similarly, cancer stem cells also have lower levels of ROS since the cancer stem cells produce a higher level of the antioxidant proteins than do non-stem-cell cells. The antioxidant proteins in turn intercept and deactivate the ROS before cellular damage has been incurred. In non-stem-cell cells, this protective mechanism poses a distinct advantage, while in cancer stem cells it is a distinct disadvantage. Cancer stem cells with low ROS levels were found to be twice as likely to survive a course of ionizing radiation than were other tumorous cells that had higher levels of ROS.

The discovery of the protective protein expression now offers a new approach to cancer treatment: the scientists found that blocking the generation and activation of the protective proteins makes the cancer stem cells more susceptible to radiation, especially when glutathione is blocked, as this is one of the strongest of all antioxidants. Of course, it is important to block the protective protein expression only in the cancer stem cells, and not also in the normal, noncancerous and non-stem-cell cells.

According to Dr. Michael Clark, associate director of the Stanford Institute for Stem Cell and Regenerative Medicine and the original discoverer of the first cancer stem cell in a solid tumor, “The resistance observed in the breast cancer stem cells seems to be a similar if not identical mechanism to that used by normal stem cells. Although your body would normally eliminate cells with chromosomal damage, it also needs to spare those cells responsible for regenerating and maintaining the surrounding tissue – the stem cells. It’s protective. Basically, we need to figure out a way to inactivate that protective mechanism in cancer cells while sparing normal cells.”

As Dr. Robert Cho adds, “Our ultimate goal is to come up with a therapy that knocks out the cancer stem cells. If you irradiate a tumor and kill a lot of it but leave the cancer stem cells behind, the tumor has the ability to grow back,” which in fact is exactly what often happens, thereby leading to relapses in patients months or even years after a seemingly successful treatment. Although the debate over the exact origin of cancer stem cells has not yet been put to rest, there is no debate over the fact that cancer stem cells, even in very small quantities, can reconstitute an entire tumor cell population, and the natural resistance of these cells to conventional medical therapies such as radiation has continued to pose a major dilemma to oncologists and their patients. Now, there may be at least a partial solution.

According to radiation oncologist and post-doctoral fellow Maximilian Diehn, M.D., Ph.D., “Since cancer stem cells appear to be responsible for driving and maintaining tumor growth in many tumors, it is critical to understand the mechanisms by which these cells resist commonly used therapies such as chemotherapy and radiotherapy. Ultimately, we hope to improve patient outcomes by developing therapeutic approaches that directly target cancer stem cells or that overcome their resistance mechanisms.”

Nanotubes Expedite the Healing Power of Stem Cells

Scientists at the University of California at San Diego have discovered how to combine nanotubes with adult stem cells to accelerate bone growth.

In what represents yet another novel convergence of previously disparate fields, namely, medicine and the strictly inorganic field of materials science, bioengineers have taken mesenchymal stem cells that were derived from bone marrow and grown them on the tops of very thin titanium oxide nanotubes. Such a procedure, the scientists discovered, allows for greater control over the differentiation of the stem cells. More specifically, it is by varying the dimensions of the nanotubes that selective differentiation of the stem cells can be induced, such as, for example, into osteoblasts for the repair of injured bone. Simply stated, the larger the diameter of the nanotube, the larger the resulting elongation of the surface of the stem cells when compared to those stem cells that are grown on narrower nanotubes.

According to Dr. Sungho Jin, a coauthor of the paper, “If you break your knee or leg from skiing, for example, an orthopedic surgeon will implant a titanium rod and you will be on crutches for about three months. But what we anticipate through our research is that if the surgeon uses titanium oxide nanotubes with stem cells, the bone healing could be accelerated and a patient may be able to walk in one month instead of being on crutches for 3 months. Our in-vitro and in-vivo data indicate that such advantages can occur by using the titanium oxide nanotube-treated implants, which can reduce the loosening of bones, one of the major orthopedic problems that necessitate re-surgery operations for hip and other implants for patients. Such a major re-surgery, especially for older people, is a health risk and significant inconvenience and is also undesirable from the cost point of view.”

Dr. Seunghan Oh, another author of the article, adds, “What we have accomplished here is a way to introduce desirable guided differentiation using only nanostructures instead of resorting to chemicals.”

As Dr. Jin further explains, “The use of nano-topography to induce preferred differentiation was reported in recent years by other groups, but such studies were done mostly on polymer surfaces, which are not desirable orthopedic implant materials.” According to Dr. Shu Chien, director of the new Institute of Engineering in Medicine at UC San Diego, “Our research in this area has pointed to a novel way by which we can modulate the stem cell differentiation, which is very important in regenerative medicine. This will lead to a truly interdisciplinary approach between engineering and medicine to getting novel treatments to the clinic to benefit the patients.”

Indeed, the field of regenerative medicine is becoming increasingly interdisciplinary, as the mere name of the newly established Institute of Engineering in Medicine suggests. The previous, erroneous paradigm in which distinct and separate scientific and medical fields are somehow expected to evolve independently of each other is demonstrably false, today more than ever before. Increasingly so, it is the cross-pollenation of ideas between disciplines which is driving the advancement of science and technology, and which is an especially vital and essential ingredient in the development of successful stem cell therapies.

California Embryonic Stem Cell Funding is Delayed

Citing weakness in the bond market as a result of the recent global financial crisis, the governing board of the California Institute for Regenerative Medicine has announced that it will halt the scheduled funding of stem cell scientists at six Bay Area research laboratories. Of the $58 million in stem cell funding which has been halted, approximately $17 million was earmarked for university programs throughout California which were intended for the training of laboratory technicians, and without which many laboratories will be understaffed.

Voted into law in 2004 with the passing of Proposition 71, the California Institute for Regenerative Medicine is the agency that was specifically created for the purpose of funding stem cell research, with a high priority on embryonic stem cells, in the state of California through sources unrelated to federal tax dollars. Such an initiative was therefore perfectly legal as it did not constitute a violation of the restrictions imposed by President Bush on the use of federal tax dollars for embryonic stem cell research. However, the California Institute for Regenerative Medicine was financially structured such that its mere existence is heavily dependent upon the bond market, which has suffered seriously in recent months. Although its board members have determined that the Institute still has enough money to fulfill its grant obligations through September of 2009, the decision was nevertheless made to delay the actual distribution of funds until March, in order to assess the full extent of losses incurred to and by the bond market.

According to the original plan, the total “fiscal impact” of Proposition 71 was structured at approximately $6 billion, half of which was designated as principal and the other half of which was expected to be generated from the interest on general obligation bonds, a type of municipal bond, that would be issued to finance the funding that is to be awarded by the Institute. Although a certain percentage of the money is allocated to cover administrative expenses, the bulk of the $6 billion would then be distributed in the form of grant money at an annual average of $200 million over 30 years. Due to the current global economic crisis, however, which is the worst since the Great Depression of the 1930s, investments in a number of sectors, including the bond market, have unexpectedly evaporated in recent months.

Multiple Sclerosis Patients Improve After Adult Stem Cell Therapy

Physicians at Northwestern University in Chicago have reported dramatic improvement in patients who were treated with adult bone marrow stem cells for multiple sclerosis (MS). Led by Dr. Richard Burt, the doctors treated eleven women and ten men who had had MS for approximately 5 years but who were still in the early stages of the relapsing-remitting form of the disease, and who had been unresponsive to conventional medical treatment. The adult stem cell therapy consisted of autologous hematopoietic stem cells that were extracted from each patient’s own bone marrow, and follow-up monitoring of the patients was conducted for 3 years.

The adult stem cell therapy was found to halt, and in some cases even reverse, the progression of the disease. Although all of the 21 patients who participated in the clinical trial improved, 17 patients exhibited improvement that was measurable by one point or more on a standardized disability scale, which is considered to be a statistically significant improvement. MRI scans and other imaging techniques showed that remyelination had occurred, and further testing revealed that the stem cell therapy had “cleansed” the immune system of defective white blood cells.

The study confirms similar results obtained by doctors Gianluigi Mancardi and Riccardo Saccardi at the University of Genoa in Italy earlier last year.

Approximately 400,000 people in the U.S. alone have been diagnosed with various forms of MS, which is an autoimmune disease that is characterized by progressive neurological degeneration and which has previously been considered incurable.

Prior to receiving the autologous stem cell transplantation in the clinical trial led by Dr. Burt, each patient also underwent immunological myeloablation, in which radiation is employed to destroy the patient’s immune system. While such a procedure has previously been considered a necessary part of the therapy, even though it exposes the patient to potentially life-threatening risks, today an increasing number of doctors are questioning the logic and necessity of subjecting their patients to deliberate immune destruction. In a publication that appeared in the Journal of Translational Medicine in January of 2007, Dr. Neil H. Riordan et al. posed the following question: “…in patients who are not suffering from a disease that is associated with an aberrant bone marrow such as hematological malignancies or immunological dysfunctions, how is it justifiable to subject them to the high levels of morbidity and mortality associated with immune suppression?” Dr. Riordan and his team of scientists then examined compelling evidence which strongly indicates that pre-transplant immune suppression is unnecessary for many types of autologous hematopoietic cell therapies and even for some allogeneic therapies that utilize “universal donor” cells such as mesenchymal stem cells and the CD34+ stem cells that are found in umbilical cord blood. As Dr. Riordan and his colleagues wrote in their 2007 paper in a section that is subtitled, “Mesenchymal stem cells do not need myeloablation for efficacy”: “Currently there are several ongoing clinical trials in Phase I-III using ‘universal donor’ mesenchymal stem cells in non-conditioned recipients of Crohn’s disease, GVHD (graft-versus-host disease) and myocardial infarction. Although these cells are bone marrow expanded mesenchymal cells, the superior proliferative potential of cord blood mesenchymal cells may allow them not only to escape immune destruction, but also to expand in vivo and mediate therapeutic effects superior to those derived from bone marrow. The fact that regulatory agencies have allowed advancement of ‘off-the-shelf’ universal donor mesenchymal stem cells supports the numerous reports of clinical efficacy in an allogeneic setting.”

Nevertheless, as Dr. Burt and his colleagues at Northwestern University have reported, their adult stem cell procedure, even though it was preceded by the systematic destruction of each patient’s immune system, “not only seems to prevent neurological progression but also appears to reverse neurological disability” in multiple sclerosis, and the results “imply that this is a valuable alternative to the transplant conditioning therapies used so far.”

One can only conclude, therefore, that patients would exhibit even greater improvement if they did not have to recover from the deliberate and life-threatening destruction of their immune systems prior to receiving the stem cell therapy, and also if the stem cell therapy would utilize the “superior proliferative potential” of the “immune privileged” adult stem cells that are found in umbilical cord blood.