Parkinson’s Disease Successfully Treated with Adult Stem Cells

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.”

Fetal Stem Cell Therapy Could Prove Fatal

An Israeli boy who suffers from a rare, often fatal genetic disease known as ataxia telangiectasia (A-T) has developed a tumor that was directly traced to the fetal stem cell therapy that he received. No known cure exists for A-T, which causes degeneration of the brain regions that control movement and speech, and people with the disease usually do not survive past their teens or twenties. Consequently, when the boy was 9 years old, his family traveled to Moscow so that he could receive an experimental therapy consisting of intracerebellar and intrathecal injections of human neural fetal stem cells – derived from aborted human fetuses – which were then injected into the boy’s brain and spinal cord as a treatment for his A-T. Even though he received two more treatments with the fetal stem cells at the ages of 10 and 12, he still had not shown any improvement by the age of 13 and in fact the severity of his disease had progressed to such an extent that he required a wheelchair. When he began having headaches, tests conducted at the Sheba Medical Center in Tel Aviv revealed a multifocal brain tumor pressing against both his brain stem and his spinal cord, which biopsy revealed to be a glioneural neoplasm. The tumor was surgically removed in 2006 when the boy was 14 years old, at which time cytogenetic and molecular analysis of the tumor revealed it to be of the same tissue as the fetal stem cells, and was therefore caused directly by the fetal stem cell therapy. Among other tests, genetic analysis revealed that some of the cells of the tumor had originated from a female donor and were comprised of 2 normal, healthy copies of the gene in which mutations cause the A-T disease, and which therefore did not match the boy’s own genotype containing abnormal copies of the gene.

Had this tumor not been discovered and surgically removed, it certainly would have been fatal and the boy would have died – not from the A-T disease, but from the therapy which was meant to treat the A-T disease. Indeed, one of the most serious concerns with embryonic and fetal stem cells is that they might constitute “therapies” which are worse than the diseases that they are meant to treat. This particular example with a boy suffering from A-T offers strong evidence to justify exactly such a concern. The boy is being closely monitored for any other tumors which might also possibly develop over time, as a lingering yet direct result of the fetal stem cell therapy that he received.

The formation of tumors has long been one of the main concerns associated with embryonic and fetal stem cells, and the fact that this boy’s tumor was not detected until 4 years after his first treatment raises some new concerns. According to Dr. Marius Wernig of Stanford University, “Stem cell transplantations have a humongous potential. But if people rush out there without really knowing what they’re doing, that really backfires and can bring this whole field to a halt.”

As Josephine Quintavale of the public interest group Comment on Reproductive Ethics adds, “The risks of tumor formation in association with embryonic stem cells are widely acknowledged and one reason why there are very serious concerns about the proposed use of such cells in treating spinal cord injury in the US. It would appear from this report that fetal stem cells are similarly unstable. These are not areas of therapy we should be rushing into, whatever the ethical debates surrounding the use of embryo or fetal tissue per se.”

Dr. Stephen Minger of King’s College London further explains, “This is worrying and we have to be cautious. We need to have long term monitoring and follow-up of the patients who are given stem cells and rigorous regulation of centres providing cell therapy. Although this is just one case, it does show that we need to be careful about the cell population we are using.”

As we have often explained on this website, all stem cells are not created equal, nor do they behave equally, and important distinctions must be made between the different types of stem cells. Generally speaking, all stem cells fall into 2 broad categories: adult stem cells, and everything else. The latter category includes embryonic and fetal stem cells, while stem cells that are derived from umbilical cord and placental blood are categorized as “adult” stem cells. The relatively recently discovered endometrial regenerative cells (ERCs), which have shown to be particularly promising, also fall into the category of “adult” stem cells. It is important to understand that adult stem cells behave very differently from embryonic and fetal stem cells, with one of the major differences being the risk of tumor formation, which has long been known to be inherently problematic in embryonic and fetal stem cells, especially in regard to the formation of teratomas (a specific type of tumor), which is the definitive requirement of pluripotency; by sharp contrast, however, adult stem cells do not cause tumors because adult stem cells are not pluripotent, but are instead multipotent, at best. In the past, the lack of pluripotency in adult stem cells was seen as a disadvantage, although increasingly it is being recognized as a distinct advantage, since it eliminates any danger of tumor formation.

According to a warning issued by Dr. John Gearhart, a stem cell scientist at the University of Pennsylvania, “Patients, please beware. Cells are not drugs. They can misbehave in so many different ways, it just is going to take a good deal of time.”

Although this particular case of tumor formation was originally reported in the PLoS medical journal, a peer-reviewed open access journal published by the Public Library of Science, the story was subsequently republished in all major media outlets around the world. As the authors of the PLoS paper cautiously conclude, “This is the first report of a human brain tumor complicating neural stem cell therapy. The findings here suggest that neuronal stem/progenitor cells may be involved in gliomagenesis and provide the first example of a donor-derived brain tumor. Further work is urgently needed to assess the safety of these therapies.”

Blindness Successfully Treated with Adult Stem Cells

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.”

Endometrial Regenerative Cells Inhibit Cancer

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.”

Geron’s Efforts in Europe are Thwarted

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.

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.