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

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

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

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

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

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

Now the problem is a little more complex.

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

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

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

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

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

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

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

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

Today at the ISSCR Meeting in Barcelona, the merger of two stem cell companies, IZumi Bio and Pierian Inc was announced, with the new company being named IPierian. According to the new company’s website iPierian is

"…a pioneering biopharmaceutical company that is taking the cutting-edge technologies of cellular reprogramming and directed differentiation to an entirely new level to harness the power of induced pluripotent stem cells to advance the understanding of human diseases and accelerate the discovery of more effective therapeutics for patients"

The two precursor companies, iZumi and Pierian, both had synergistic skills in the area of inducible pluripotent stem cells (iPS), a type of "artificial stem cell" that is created from skin or other tissues. The use of iPS cells for therapeutics development is more attractive to scientists than embryonic stem cells for several reasons. Firstly, iPS cells can be generated to be patient-specific, thus overcoming problems with need for taking of immune suppressants. Currently embryonic stem cells can not be used in patients for several reasons, and the few times that their use is contemplated, the patient is sentenced to taking life-long immune suppression so that they do not undergo rejection. Secondly, iPS cells can be generated under highly defined conditions. Embryonic stem cells that are currently used have been developed years ago and face various problems such as the fact that many of them have previously been grown on mouse cells or using animal products. In contrast, iPS cells can be generated with relatively little effort.

iZumi was supported by the venture capital groups Kleiner Perkins Caufield & Byers and LExington, Mass.-based Highland Capital Partners with a $20 million investment, whereas Pierian was founded by MPM Capital managing directors Ashley Dombkowski and Robert Millman as well as Harvard University scientists. The new company, which will be led by John Walker as CEO and Corey Goodman, as Chairman, raised an additional $10 million from Boston-based MPM Capital and $1.5 million from FinTech Capital Partners.

Initial goals of the company will be use of the iPS cells to address disease affecting the central nervous system that have no effective treatment such as spinal muscular atrophy, Parkinson’s Disease, and ALS. In the long-run the company plans to investigate conditions such as heart failure, liver failure, and diabetes. As part of the new company’s strategy, it will seek synergistic collaborations with established market players.

Despite the aggressive goals the company has set for itself, there are several drawbacks that one must consider. Firstly, pluripotent stem cells, regardless of whether they are iPS or embryonic stem cells, all cause cancer when administered into animals. iPS may be especially dangerous since oncogenes (genes that cause cancer) are needed for the creation of these cells. In order for iPS to be used safely, it will be necessary to make sure that the cells being made for injection are completely the cells that one wants, and no contamination with the original iPS cells. In other words, if one is treating Parkinson’s Disease, one can not simply inject iPS cells into the area of the brain that is damaged, since this conceptually will form a tumor. In contrast, one would have to "teach" the iPS cells to become the specific cell that is damaged in Parkinson’s Disease, called the "dopaminergic neuron", one will have to concentrate these cells outside of the body, and then inject them directly where they are needed. Once the cells are injected, they will have to form connections with the existing cells and subsequently integrate and take over their function. This is in contrast to the present-day clinically available adult stem cell therapies, where in many cases adult stem cells are injected either intraviously or intrathecally, and the natural signals of the body instruct them to differentiate into the needed tissue. Although differentiation efficacy of adult stem cells may be lower on a per cell basis, of the thousands of people that have been treated with adult stem cells no reports of tumor formation exist.

iPierian’s scientific leadership comes from the respected embryonic stem cell experts Dr. George Daley, Douglas Melton and Lee Rubin who are faculty at Harvard. The scientific advisory board (SAB) of the company will be chaired by Dr. George Daley, and will include Amy Wagers, Kevin Eggan, Benoit Bruneau, and Matthias Hebrok.

When Ken Milles suffered a heart attack at the age of 39, he was not given a very encouraging prognosis from his doctor. As Ken describes, "When he told me that there was permanent damage and that the duration of my life was reduced, that freaked me out."

A construction worker and father of two teenaged sons, Ken is now the first patient to volunteer in a clinical trial at the Cedars-Sinai Heart Institute in Los Angeles. One of 24 patients in the study, Ken is the first person to be treated with his own heart-derived adult stem cells.

Adult stem cells are believed to reside in all tissue types throughout the body, with each type of adult stem cell being highly specialized in producing the corresponding specific type of tissue. Some organs, such as the heart, are known to contain very small amounts of their own stem cells, but nevertheless a specialized cardiac stem cell is known to exist in the adult human heart, throughout life and into old age. The low number of naturally occurring, endogenous cardiac stem cells, however, is not usually enough to repair serious damage to heart tissue, such as that which results from myocardial infarction. But when these cardiac stem cells are isolated, cultured and expanded in the laboratory, they can be readministered to the patient in quantities that are large enough to repair even severe damage. This is exactly what Ken’s doctors are doing.

As Dr. Eduardo Marban, the leader of the study, describes, "We seek to actually reverse the injury that has been caused by the heart attack, by regrowing new heart muscle to at least partially replace the scar that’s formed. These cells that we’re putting in come from the heart itself, and are predestined to generate heart muscle and blood vessels."

Derived from a tiny sample of healthy heart tissue, the cardiac stem cells are expanded in the laboratory to 25 million stem cells, which then develop into the spherical, multicellular structures known as cardiospheres which have been found in previous clinical and preclinical trials to regenerate damaged cardiac tissue. In fact, Dr. Marban was involved in similar studies at the Johns Hopkins University School of Medicine in 2005, at which time he reported that, "The findings could potentially offer patients use of their own stem cells to repair heart tissue soon after a heart attack, or to regenerate weakened muscle resulting from heart failure, perhaps averting the need for heart transplants. By using a patient’s own adult stem cells rather than a donor’s, there would be no risk of triggering an immune response that could cause rejection."

The doctors inject the stem cells through an artery directly into the damaged tissue of the patient’s heart. Within 6 months, signs of tissue repair should become evident.

As Ken Milles has said, "If this works, it’s gonna help so many people. It’s gonna change everything."

The clinical trials will continue for the next 3 to 4 years.

The adult stem cell company Aastrom Biosciences has resumed patient enrollment in its Phase II clinical trial, entitled IMPACT-DCM, in which autologous adult stem cells are being used to treat dilated cardiomyopathy, an end-stage form of chronic, congestive heart failure. The study had been suspended on May 22 when a patient in the trial died. The U.S. Food and Drug Administration has now concluded that the death of the patient was unrelated to the clinical trial.

On May 22 it was announced that the clinical trial was suspended when a patient who was enrolled in the trial unexpectedly died after having been treated with autologous (in which the donor and recipient are the same person) adult stem cells and released from the hospital. The FDA then imposed a halt on the clinical trial, at which time Aastrom temporarily suspended further patient enrollment and treatment until the cause of death could be determined. Having completed its formal investigation, the FDA has now concluded that the cause of the patient’s death was unrelated to the clinical trial itself, but instead was merely caused by the advanced stage of the patient’s own dilated cardiomyopathy. Since the clinical trial was specifically designed to treat dilated cardiomyopathy, this disease was required as a preexisting condition for enrollment in the clinical trial, although some patients who were enrolled had more advanced and severe forms of this condition than others.

Fourteen people have been enrolled in the study thus far, which has a target enrollment of 40 patients. The dilated cardiomyopathy study is not Aastrom’s only clinical trial currently underway, however, as Aastrom is also conducting a Phase IIb clinical trial for the treatment of critical limb ischemia, an advanced form of peripheral artery disease, which is also being treated with autologous adult stem cells. According to the Aastrom’s website, "The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient." Aastrom describes itself as a "Regenerative medicine company developing personalized cell-based therapies to slow or reverse the course of chronic diseases." As stated on their website, "Aastrom’s TRC products have been used in over 325 patients, and are currently in clinical trials for cardiac, vascular and bone tissue regeneration applications, with plans to expand into the neural therapeutic area."

Headquartered in Ann Arbor, Michigan, Aastrom is focused exclusively on therapies that are developed from autologous adult stem cells, not embryonic stem cells.

Aastrom’s stock price climbed 21.8% following today’s news announcement by the FDA.

The Stem Cell Center at the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston has announced the commencement of FDA-approved Phase I clinical trials in which the Hospital is currently enrolling patients who have experienced any of three cardiovascular conditions, namely, a heart attack, heart failure or peripheral vascular disease. While patients will not be given monetary compensation for enrollment in the trials, they also will not be charged for any of the therapy or post-therapy monitoring that is conducted in relation to the trials.

The Stem Cell Center currently has several concomitant trials in which patients are being enrolled for heart failure. Qualifying patients must be on maximal medical therapy, exhibit a low ejection fraction, and have exhausted all conventional medical therapy such as bypass surgery and angioplasty. For the heart attack trials, qualifying patients must recently have been treated with angioplasty following a heart attack. For the peripheral vascular disease trials, in which adult stem cells will be injected directly into the affected areas of the leg, qualifying patients must exhibit claudication (blocked arteries in the legs) but no active infections in the leg, and must be refractive to conventional therapy.

Patients who wish to be considered for enrollment, and physicians who would like to refer a patient for consideration, should contact the Texas Heart Institute directly.

The Texas Heart Institute was founded in 1962 by the cardiac surgeon and pioneer, Dr. Denton Cooley, and today the Institute ranks as one of the largest cardiovascular centers in the world. As of 2008, doctors at the Texas Heart Institute had performed over 200,000 cardiac catheterizations, 100,000 open heart surgeries, and 1,000 heart transplants. Additionally, the Texas Heart Institute was one of only five centers selected by NIH (the National Institutes of Health) to study stem cell therapy as a treatment for cardiovascular disease, and the Stem Cell Center at the Texas Heart Institute was the first organization within the U.S. to receive FDA approval for a clinical trial in which advanced heart failure is treated with adult stem cells.

In an unusual application of radioactive carbon-14 dating, scientists have made some interesting discoveries regarding the natural activity of cardiac stem cells and the innate ability of the human heart to regenerate its own tissue throughout the entire human lifespan.

At the Karolinska Institute in Stockholm, Sweden, stem cell scientists have capitalized upon the unfortunate fact that a number of radioactive substances were released into the earth’s atmosphere as a result of the above-ground nuclear weapons testing that was conducted during the Cold War era of the 1950s and early 1960s, during which time there was a sharp spike in atmospheric levels of radioactive carbon-14, among other chemicals. Even though such levels subsequently declined after the above-ground testing of nuclear weapons was banned, C14 still continued to find its way into the cells of the human body and all other living creatures for many years thereafter, along with additional products of thermonuclear explosion such as radioactive strontium-90 which was found in the deciduous teeth of North American children during the 1950s and 1960s. Also known as radiocarbon, C14 is a radioactive isotope of carbon which occurs naturally in the upper layers of the troposphere and stratosphere when nitrogen atoms absorb thermal neutrons as cosmic rays enter the atmosphere. In the upper atmosphere, however, C14 does not present much harm to humans, whereas on terra firma it can be extremely harmful to any living organism, human or otherwise, when absorbed in sudden, high dosages by bodily tissue. With a half-life of approximately 5,730 years, C14 is not quickly “metabolized”, so to speak, and therefore has most typically been used as a reliable tool for calculating the age of organic archaeological remains, as it is readily absorbed by all living tissue. Indeed, as every first-year chemistry student knows, the presence of the element carbon is what distinguishes organic chemistry from inorganic chemistry, since biological life is not possible without carbon, and living creatures can just as easily absorb the radioactive carbon isotope into their bodily tissues as they can the regular carbon atom. Although C14 is one of the three naturally occurring carbon isotopes, it is the only one with an unstable nucleus as both C12 and C13 are stable isotopes.

Fortunately, the above-ground nuclear weapons testing that was conducted in several countries from 1955 to 1963 was finally halted as a result of the efforts of Dr. Linus Pauling who, along with his wife Ava, presented to the United Nations in 1958 a petition which called for an end to the above-ground testing and which was signed by more than 11,000 scientists from around the world. This petition, combined with subsequent pressure from the general public, resulted in an international moratorium on the testing and finally also the signing of the Test Ban Treaty in 1963 by U.S. President John F. Kennedy and Soviet Leader Nikita Krushchev. For his efforts in single-handedly mobilizing and leading such an effective public movement, Dr. Pauling received the 1962 Nobel Peace Prize, which was his second Nobel Prize, his first having been the 1954 Nobel Prize in chemistry for his elucidation of the chemical bond. Hence Dr. Pauling remains the only person ever to have won two unshared Nobel Prizes. After 1963, nuclear weapons testing continued but was transferred underground by the two major Super Powers of the Cold War era, so that radioactive fallout would not continue to contaminate the atmosphere and poison its inhabitants.

As with archaeological dating, C14 was used in this particular medical study as a cellular “clock” for measuring the age of cardiac cells in 12 deceased subjects whose ages at the time of death ranged from 19 to 73 years. Even in those individuals who had been born two decades prior to the start of nuclear weapons testing in the 1950s, C14 was still found to be abnormally elevated in their cardiac tissue, signifying that the tissue had absorbed the C14 years after birth. Similarly, in the younger deceased subjects, the C14 levels were also abnormally elevated but corresponded to a cellular age which was younger than the chronological age of the person, indicating a natural regeneration of the cells.

According to the results of this study, less than 50% of all cardiomyocytes are naturally regenerated by the heart throughout an entire human lifespan, and the rate of renewal slows with age. In the typical person who is 20 years old, for example, approximately 1% of all cardiomyocytes renew themselves each year, whereas in the typical 75-year-old person that percentage has decreased to around 0.45% of all cardiomyocytes. Mathematical modeling additionally revealed that those cells of the heart which develop into heart muscle have a lower turnover rate than do other types of heart cells, such as those that develop into blood vessels and connective tissue, which renew themselves at an annual rate of approximately 18%. Presumably it is the highly specialized nature of cardiac muscle which makes it so difficult to regenerate, since the unique electrical and mechanical properties of cardiac muscle distinguish it from all other types of muscle in the body. Precisely for such reasons, damaged heart muscle following heart attacks or traumatic injury has always been extremely difficult to heal and highly resistant to conventional therapeutic modalities.

Nevertheless, the natural potential for cellular regeneration in cardiac tissue is encouraging, albeit not statistically significant, and now scientists are turning their attention to the development of methods that might stimulate such a natural capacity.

As Dr. Jonas Frisen, a stem cell researcher at the Karolinska Institute in Stockholm who was involved in the study, explains, “We find that the beating cells in the heart, cardiomyocytes, are renewed. It has previously not been known whether we were limited to the cardiomyocytes we are born with or if they could be renewed. If we can understand how the generation of new cardiomyocytes is regulated, it may potentially be possible to develop pharmaceuticals that promote this process to stimulate regeneration after, for example, a heart attack.” Dr. Ratan Bhardwaj, also of the Karolinska Institute, adds, “A lot of people suffer from chronic heart failure, which is the result of heart cells dying. Maybe one could devise a pharmaceutical agent that would stimulate heart cells to make new and more cells to overcome the problem they are facing.”

The trick would be to increase the rate of regeneration to a level that exceeds the natural rate of cellular death, which is especially pronounced in some medical conditions which include chronic conditions such as heart failure and acute events such as a heart attack or traumatic injury. As Dr. Gregg C. Fonarow, professor of cardiology at UCLA, explains, “It was previously believed that the cardiomyocytes are terminally differentiated and cannot regenerate when the heart is damaged. Recent studies have suggested that cardiomyocytes can regenerate, but there has been substantial controversy as to the rate of cellular turnover. Whether there will be medical or gene therapies that can safely and effectively allow for higher rates of myocardial regeneration will require further study.”

According to Dr. Charles Murry, director of the Center for Cardiovascular Biology at the University of Washington in Seattle, “I am very excited about how they have used this novel technology to get something useful out of such a terrible environmental disaster.” Dr. Murry then adds, “A lot of us have been working on putting exogenous cells into the heart, but given the choice of growing my own heart back or taking all these cells from elsewhere, I would choose the pharmaceutical approach.” Not everyone shares such a personal preference, however, such as Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, who cautions, “A drug may stimulate a biochemical pathway too crudely, and in regenerative medicine we need to be very careful to avoid unregulated cell growth that could cause tumors.”

Adult stem cells are known to reside throughout the human body and have been definitively discovered in a variety of tissue types, although the search for a cardiac stem cell had been an elusive one until recently. In 2008, however, researchers at Children’s Hospital in Boston identified a group of stem cells that differentiate into cardiomyocytes and which are located in the epicardium, which is the heart’s outer layer of tissue. Their findings were published in the June 22, 2008 issue of the journal Nature, corroborating similar discoveries in 2006 at both Children’s Hospital and Massachusetts General Hospital in Boston. Since then, independent researchers have also confirmed the presence of additional cardiac progenitor cells within the epicardium. (Please see the related article on this website, entitled, “Stem Cells Discovered in Surface of Heart”, dated June 22, 2008, as originally reported in the journal Nature).

Whether through pharmaceutical stimulation or through a more natural means, scientists hope to be able to harness the innate ability of the heart to regenerate its own tissue with its own endogenous stem cells, one way or another. The mere fact that the heart is capable of such a feat, which had previously been debated for so long, is no small discovery.

Former heart patients such as Howard Lindeman and Dick Dufala are strong advocates of adult stem cell therapy, and their enthusiasm is the result of personal experience. Along with many other people who share similar stories, Mr. Lindeman and Mr. Dufala have adult stem cell therapy to thank for the fact that they are no longer in danger from the life-threatening heart conditions with which they had previously suffered.

According to Mr. Lindeman, who chose to undergo adult stem cell therapy follwing a heart attack, “It’s the most amazing thing I’ve ever been through. I had the procedure done and since then, I’ve just been getting better and better and better. I’m going to be 58 years old in May and I’m on my way to being 35 again.”

Similarly, according to Mr. Dufala, who used to suffer from congestive heart failure before receiving adult stem cell therapy, “I think it’s improved my life and my life will be extended as a result of having the procedure. I feel like I don’t have congestive heart failure. I feel quite good.”

Both men underwent their adult stem cell therapies from the cardiologist Dr. Zannos Grekos, who uses autologous (in which the donor and recipient are the same person) adult stem cells derived from each patient. Speaking at a seminar recently in Naples, Florida, Dr. Zannos explained, “Because it is coming from the patient, there’s no [immune] rejection and there’s no risk of cancer because we’ve been using adult stem cells for about 40 years in treating cancers. We know that adult stem cells are effective.”

By stating that “there’s no risk of cancer”, Dr. Zannos is referring to the fact that embryonic stem cells are defined by their ability to form teratomas (tumors), which is the formal scientific definition of pluripotency, whereas adult stem cells are not capable of forming such tumors for the simple reason that adult stem cells are not pluripotent. Similarly, in his statement that “we’ve been using adult stem cells for about 40 years in treating cancers”, Dr. Zannos is referring to the fact that bone marrow transplants have been conducted for several decades now, and the mechanism-of-action by which bone marrow transplantation is effective is through the adult stem cells that are present in the bone marrow. More specifically, the first bone marrow transplant was performed in 1956, which was over 5 decades – over half a century – ago. It was Dr. E. Donnal Thomas of Cooperstown, New York, who performed this first successful bone marrow transplant that resulted in the long-term survival of the patient who subsequently enjoyed a complete remission of leukemia after being given a bone marrow transplant from an identical twin. For this first, pioneering medical procedure, Dr. Thomas was awarded the Nobel Prize in Physiology or Medicine, along with Dr. Joseph E. Murray, “for their discoveries concerning organ and cell transplantation in the treatment of human disease.” This revolutionary transplantation paved the way for numerous other transplants of a similar nature, which in turn were followed in 1968 by the first bone marrow transplant from a related donor in the treatment of a non-cancerous condition, namely, in the treatment of a four-month-old boy who had inherited severe combined immunodeficiency syndrome. This procedure in turn opened the door for numerous other bone marrow transplantations for non-cancerous conditions, which in turn were also followed in 1973 by the first bone marrow transplant using an unrelated donor, which was performed at Memorial Sloan-Kettering Cancer Center in New York City and which likewise paved the way for numerous other procedures of a similar nature. It has therefore been for over the past 50 years that bone marrow transplantation has demonstrated the safety and efficacy of the adult stem cells that are present in bone marrow. If one were to trace the history of umbilical cord blood therapies, one would find that these therapies extend back even farther in time and predate World War II by at least a decade, and for over the past 70 years the various uses of the adult stem cells that are present in umbilical cord blood have been documented in the medical literature for the treatment of a vast number of people for a variety of conditions, without adverse side effects. Although the concept of a human stem cell, per se, was not yet understood at these times, prior to World War II nor even in 1956 when the first bone marrow transplant was performed, today it is well known and understood that bone marrow transplants and umbilical cord blood work as effective treatments because of the adult stem cells that they contain. By contrast, the first human embryonic stem cell was only isolated in the laboratory in 1998, so embryonic stem cell science is barely a decade old, and in that short decade embryonic stem cells have never been used to treat anyone for anything. A clinical history, therefore, does not exist, at all, for embryonic stem cells, which thus far can be said to have a 0% success rate, which is the equivalent of a 100% failure rate. Since embryonic stem cells carry a number of inherent risks, not the least of which is their strong natural ability to form teratomas (tumors), even the most ardent of embryonic stem cell proponents has cautioned that an actual therapy based upon embryonic, not adult, stem cells is at least another decade away, if such a goal is attainable at all. Meanwhile, there are many patients who cannot wait that long for treatment, and fortunately adult stem cells are already being used as clinical therapies to help such people.

In reference to the natural regenerative ability of the body’s own adult stem cells, even in full-grown adults, Howard Lindeman adds, “The people who doubt it should stop doubting because it is a fact that our body can heal itself. If it didn’t, I’d be dead right now.”

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.

In a controversial landmark decision, the U.S. Food and Drug Administration (FDA) has granted approval to the California-based biotech company Geron to commence the first human clinical trials ever to be conducted with embryonic stem cells. The trials, which are scheduled to begin in the summer of 2009 at 7 participating medical centers, will consist of administering embryonic stem cells in 8 to 10 paraplegic parients at the site of injury as soon as possible after an injury but no later than 2 weeks following an injury, before scar tissue has had time to develop. The objective of Phase I of the trials, which will be limited to patients with injuries in the middle of the spine, will be to evaluate safety. Evaluations of efficacy, in the form of patient improvement, will come later. Participating patients will also receive immunosuppressive drugs for the first couple of months in order to help minimize the risk of immune rejection. Follow-up will last for at least one year.

According to Dr. Thomas B. Okarma, Geron’s president and CEO, “This approach is one that reaches beyond pills and scalpels to achieve a new level of healing.” Nevertheless, the procedure comes with a disclaimer, since the treatment is neither expected to be a total nor an immediate cure, nor are patients expected to experience a significant restoration of function. As Dr. Okarma explains, “Any return of bladder or bowel function, a return of sensation, or a return of lower extremity locomotion would be a very exciting finding.”

Similarly, Peter Kiernan, chairman of the Christopher And Dana Reeve Foundation, is hopeful but cautious not to inflate expectations unrealistically. As he explained, “Of the millions of people dealing with paralysis in our nation, they are all delighted with subtle increases in function. We eat, drink, sleep getting people out of wheelchairs, but the reality of the world we are in is if people get bowel function, some sexual function, some ability for movement, that’s a wonderful outcome.”

The embryonic stem cells that will be used in Geron’s clinical trials were obtained from one of the already existing embryonic stem cell lines that former President Bush had approved for research, and is unrelated to President Obama’s promises of policy changes, which have yet to occur.

However, a number of million-dollar questions still remain unanswered, especially those related to whether or not immunosuppressive drugs will be enough to prevent an immune rejection of the stem cells, and whether or not these embryonic stem cells will cause teratomas in the patients. Time will tell.

The ability of embryonic stem cells to form the specific type of tumor known as a teratoma is the universal laboratory test by which embryonic stem cells are identified, since the ability to form a teratoma is, by definition, the measure of pluripotency. In stem cell laboratories throughout the world, if a cell is able to form a teratoma, then it is recognized as being an embryonic stem cell or some other type of pluripotent stem cell, but if it is not able to form a teratoma then it is recognized as being some other type of cell which is not embryonic and which lacks pluripotency. It is precisely for inherent medical risks such as teratomas that embryonic stem cells had not received previous FDA authorization to be used in clinical trials in the U.S., prior to Geron. Since adult stem cells are not pluripotent but instead are multipotent, they do not pose the risk of teratoma formation which is why adult stem cells are already being used in clinics around the world to treat patients with a wide variety of diseases and injuries. By sharp contrast, scientists agree that any hope of a safe and effective clinical therapy being developed from embryonic stem cells is still at least another decade away, if not further.

The cost of the therapy also remains an unknown factor, as well as the extent to which such a medical expense might be covered by insurance. No doubt all questions will be answered in time, however.

Attaining FDA approval to begin the testing of embryonic stem cells required what has been described by many in the field as a herculean effort, which cost Geron more than $150 million dollars in preliminary research that was conducted over a span of 13 years. Now, many more years of expensive clinical trials will still be required before the FDA can consider approving Geron’s embryonic stem cells for availability on the U.S. market.

Geron Corp. was heavily involved in the funding of Dr. James Thomson’s laboratory at the University of Wisconsin at Madison in the 1990s, when Dr. Thomson became the first person to isolate an embryonic stem cell, first from a primate in 1995 and later from a human in 1998. Current plans at Geron are also in progress for the development of embryonic stem cells in the treatment of heart failure and in the growth of insulin-producing beta islet cells for the treatment of Type 1 diabetes.

Doctors in Germany have reported improvement in the cardiac function of a 2-year-old child who was critically ill with severe heart failure caused by dilated cardiomyopathy (DCM), and who improved after receiving autologous adult stem cell therapy.

Led by Dr. Stefan Rupp of the Pediatric Heart Center at Justus-Liebig University in Giessen, Germany, the team of physicians conducted an intercoronary administration of autologous adult progenitor cells derived from the infant’s own bone marrow. As described in their article, “DCM is the most common cardiomyopathy in childhood. Effectiveness of anticongestive therapy is limited in most cases and about one-third of children diagnosed with DCM die or receive heart transplantation within the first year after diagnosis.”

This case documents the first instance of an autologous adult stem cell treatment administered to a patient this young, whose condition was progressively worsening despite maximal anticongestive therapy prior to receiving the autologous adult stem cells, and who has consequently shown measurable improvement as a result of the autologous adult stem cells.

As the authors conclude, “Cardiac stem cell therapy proved to be technically feasible, was associated with improvement in cardiac function, and might represent an option before heart transplantation in children with severe heart failure.”