In an article entitled "The Dirty Secret of Embryonic Stem Cell Research", the noted science journalist, author, attorney and director of the Independent Journalism Project, Michael Fumento, writes an eye-opening assessment of the stem cell field.

Michael Fumento begins his article in today’s issue of Forbes by citing the widespread, popular consensus among the general, nonscientific public that cures for all sorts of diseases are imminent, now that the infallible Obama administration has suddenly lifted all restrictions which the nefarious Bush administration imposed upon stem cell research. Such popular consensus, however, is grossly misguided and uninformed, as Mr. Fumento proceeds to demonstrate.

As Mr. Fumento points out, "Quadriplegics probably shouldn’t sign up for the New York City Marathon just yet. If these cures are just around the corner, this corner is far, far away. And that’s according to embryonic stem cell researchers and funding advocates themselves. The time frame for the first of those miracles seems routinely to be given as a ‘decade’, as in ‘a decade away’ or ‘a decade off.’ And it keeps shifting."

Fumento then reminds the reader that in 1998, when Dr. James Thomson isolated the first human embryonic stem cell in the laboratory, it was reported in an article at that time that Dr. Thomson and his colleagues themselves "warn that such clinical applications are perhaps as much as a decade away." That was in 1998, which by now was over a decade ago – and still, as of 2009, there have not yet been any clinical applications, not even one, that have resulted from human embryonic stem cell research. Continuing from the 1998 article, as Fumento then adds, "Check your calendar. Addressing a 2007 Wisconsin convention 9 years later, Thomson articulated that the time frame had shifted to ‘decades away’, plural."

As Fumento goes on to explain, "The scientists didn’t blame too little federal funding, as have others, according to the Associated Press. Rather, Thomson blamed simple biology. Among other problems, embryonic stem cells require permanent use of dangerous immunosuppressive drugs. They have a nasty tendency to form tumors both malignant and benign including teratomas – meaning ‘monster tumor’. Teratomas can grow larger than a football and can contain eyeball parts, hair and teeth." As Fumento further exclaims, "Yech!"

He goes on to ponder, "OK, so how many ‘decades’?" Among others, the answer is given by William Haseltine, former CEO of The Human Genome Project, who told the Agence France Presse in 2001 that, "The routine utilization of human embryonic stem cells for medicine is 20 to 30 years hence", to which Haseltine further added, "The timeline to commercialization is so long that I simply would not invest." There are other embryonic stem cell researchers, however, who believe that "3 to 5 decades" is more realistic, while the British fertility expert and Imperial College, London University professor Lord Robert Winston proclaimed in a 2005 lecture that, "I am not entirely convinced that embryonic stem cells will, in my lifetime and possibly anybody’s lifetime for that matter, be holding quite the promise that we desperately hope they will," further adding that "one of the problems is that in order to persuade the public that we must do this work, we often go rather too far in promising what we might achieve."

Fumento further points out that the 2007 AP article stated, "One day, some believe embryonic stem cells will become sources of brain tissue, muscle and bone marrow to replace diseased or injured body parts." In other words, maybe "one day" in the future, even though such goals have not yet been attained with human embryonic stem cells, not even as recently as 2007 nor even today in 2009. Meanwhile, however, various types of adult stem cells have already been differentiated into these and other types of tissue, decades ago. As Fumento explains, "Life-saving marrow regeneration with stem cells dates back to 1956."

Additionally, "Adult stem cells have now treated scores of illnesses including many cancers, autoimmune disease, cardiovascular disease, immunodeficiency disorders, neural degenerative diseases, anemias and other blood conditions," Fumento points out. "They’ve been used in over 2,000 human clinical trials. There has never been an embryonic stem cell clinical trial. Former National Institutes of Health director Dr. Bernardine Healy, once an embryonic stem cell research enthusiast, now calls them ‘obsolete’."

Indeed, as previously reported a number of times on this website, Dr. James Thomson himself – widely revered as "the father of embryonic stem cell science" – has often emphasized the importance of other types of cells, especially iPS (induced pluripotent stem) cells, over embryonic stem cells. In fact, the company which Dr. Thomson cofounded, Cellular Dynamics International, has as its primary focus today the commercialization of iPS cells, not embryonic stem cells – and not for the development of actual cell-based clinical therapies, but instead for the use of these iPS cells in drug screening and pharmaceutical development. (Please see a number of articles on this website related to Cellular Dynamics International, including but not limited to those entitled, "Leading Researcher Joins Cellular Dynamics", dated July 22, 2009; "Wisconsin Stem Cell Company Announces Licensing Agreement", dated July 15, 2009; "Cellular Dynamics Creates iPS Cells From Human Blood", dated July 8, 2009; and "Cellular Dynamics and Mount Sinai Sign Licensing Agreement", dated May 29, 2009).

As Fumento concludes, "In justifying his stem cell research executive order, President Barack Obama cited ‘a consensus of the majority of Americans.’ Actually, the polling responses vary tremendously depending on the questions asked. But no decision is better than the information upon which it’s based. What might Americans think if they knew the embryonic stem cell reseach ‘decades away’ secret?"

(Please see a number of articles on this website related to the embryonic stem cell versus adult stem cell controversy, including but not limited to that entitled, "Former Director of N.I.H. Explains Why Embryonic Stem Cells are Obsolete", dated March 4, 2009, as originally reported in U.S. News & World Report).

Physicians in Barcelona are using autologous adult stem cells derived from bone marrow to treat Crohn’s disease. In other countries such as the U.S. and Italy the same procedure has already obtained excellent results, with 80% of all patients still in total remission as long as 6 years after treatment, and considerable improvement also observed even in the 20% of patients who experience partial but not complete remission.

Dr. Julian Panes and Dr. Elena Ricart of the gastroenterology department at the Hospital Clinic in Barcelona have treated 6 patients thus far, 3 of whom have already completed the therapy and the other 3 of whom are still undergoing therapy. All patients are confident that they will improve.

However, the procedure in Barcelona begins with an initial treatment of chemotherapy for the specific purpose of destroying the patient’s immune system – the logic and necessity of which are being increasingly questioned. While such a procedure had previously been considered a necessary part of such therapy, even though it exposes the patient to potentially life-threatening risks, today an increasing number of doctors are questioning the medical wisdom and scientific validity of subjecting their patients to deliberate immune destruction, and in fact there is a growing body of evidence to support the idea that such dangerous immunosuppression is unnecessary. In a publication that appeared in the Journal of Translational Medicine over two years ago, 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-stem cell 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 from 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.”

Although a total remission rate of 80% is quite impressive, one can only conclude that the rate would be even higher if the patients did not have to recover from the deliberate and life-threatening destruction of their immune systems prior to receiving the stem cell therapy, and also if the stem cell therapy would utilize the “superior proliferative potential” of the “immune privileged” adult stem cells that are found in umbilical cord blood.

Crohn’s disease is a painful, inflammatory, chronic, autoimmune disease of the digestive tract for which there has previously been no known cure and which, if left untreated, is potentially fatal. Complications are numerous, conventional medical treatments are ineffective and carry a high risk of dangerous side effects, and although the precise causes are unknown there seems to be a strong genetic component associated with the disease, which afflicts approximately half a million people in the U.S. alone and over 150,000 people in Spain. Now, adult stem cells offer the first therapy that has ever actually been shown not only to reverse the course of the disease but also to heal the patient of associated physiological injury.

The stem cell company Pluristem Therapeutics has filed an IND (investigational new drug) application with the U.S. FDA and its European counterpart to begin Phase I clinical trials for the treatment of critical limb ischemia with the proprietary adult stem cell product PLX-PAD, an allogeneic placental-derived stromal cell product.

The trials, which are to be conducted at clinical sites in the U.S. and Europe, will enroll patients who are suffering from “late stage” limb ischemia that has been unresponsive to conventional medical and surgical interventions, and for whom amputation is the only other remaining option.

As the president and CEO of Pluristem, Zami Aberman, explains, “We are pleased to be filing this IND application in the U.S.. Following approval by the FDA, we will begin administering PLX-PAD to patients afflicted with critical limb ischemia with the goal of proving this product safe. The IND application filed with the FDA and the IMPD (investigational medicinal product dossier) application filed in Europe are two important steps in Pluristem’s global strategy to become a dominant player in the cellular therapeutic business arena.”

According to Edwin M. Horwitz, M.D., Ph.D., Director of Cell Therapy in the Division of Oncology and Blood and Marrow Transplantation at the Children’s Hospital of Philadelphia, and chairman of Pluristem’s Scientific Advisory Board, “This is an exciting time for Pluristem. Success in this endeavor will signify the first time an adult stem cell, derived from the placenta and grown using the company’s PluriX 3D technology, has been administered to humans safely. This will represent a major advance in cell therapy and position Pluristem as an international leader in the field.”

As Dr. Brian Annex, Chief of the Division of Cardiovascular Medicine in the Department of Medicine at the University of Virginia School of Medicine, and a member of Pluristem’s Scientific Advisory Board, adds, “If Pluristem’s clinical trial is successful, this will be a major advance in the field of cellular therapeutics with the use of an allogeneic off-the-shelf product that needs no matching for peripheral vascular disease and then, potentially, other diseases.”

It has been estimated that between 8 and 12 million people in the U.S. alone suffer from critical limb ischemia (CLI), an advanced stage of peripheral artery disease (PAD). Industry analysts have estimated the market potential for the treatment of CLI to be over $1 billion, although conventional medical treatments of this life-threatening condition are often unsuccessful, thereby leaving a therapeutic void which cell-based therapies are uniquely qualified to fill.

Pluristem Therapeutics is focused on the development and commercialization of off-the-shelf allogeneic cell-based therapies for the treatment of chronic degenerative ischemic and autoimmune disorders. As described on their website, Pluristem specializes in adherent stromal cells (ASCs) that are derived from the placenta and which “are multipotent adult stem cells that have strong anti-inflammatory properties and can regenerate and repair damaged tissue.” ASCs have already been shown to differentiate into nerve, bone, muscle, fat, tendon, ligament, cartilage and bone marrow stroma. Additionally, since they have low immunogenicity, ASCs do not require HLA (human leukocyte antigen) matching and are not at risk of being rejected by the patient’s immune system.

After the ASCs are harvested from placental tissue, the cells are then expanded three-dimensionally into PLX (PLacental eXpanded) cells via the company’s proprietary PluriX 3D bioreactor, in which the cells are able to excrete their own cytokines and other immune modulators without the need for supplemental growth factors nor other exogenous materials. Like ASCs, PLX cells exhibit immunomodulatory properties and are “immune privileged” and as such do not pose any threat of immunological rejection.

As adult stem cells which are derived from the human placenta, which is an extremely rich non-embryonic source of stem cells, ASCs are also ethically non-controversial in addition to being highly potent adult stem cells.

Researchers at the Feinberg School of Medicine at Northwestern University in Chicago have conducted a review of the medical literature in which adult stem cells derived from blood and bone marrow were utilized in the treatment of nonmalignant, nonhematologic conditions. In particular, the scientists and doctors reviewed reports that were published between 1997 and 2007 on the use of hematopoietic stem cells (HSCs) in the treatment of autoimmune, cardiac and vascular diseases. From a total of 926 reports, 323 were specifically analyzed for feasibility and toxicity.

The team of researchers, which was led by Dr. Richard Burt, concluded that adult stem cell therapy is effective at treating the diseases and at relieving the symptoms of the diseases, while contraindications and side effects were negligible, at less than 1% in most studies. As the scientists stated in their own words, and as published in their report in JAMA, “Stem cells harvested from blood or marrow, whether administered as purified HSCs or mesenchymal stem cells or as an unmanipulated or unpurified product can, under appropriate conditions in select patients, provide disease-ameliorating effects in some autoimmune diseases and cardiovascular disorders.”

Researchers hope that the conclusions drawn from such a literature review might encourage further progress in the formal recognition by legislators and the medical community of the clinical safety and efficacy of adult stem cells.

By Regina Sass, University of California – San Diego Medical Center

With the potential to have great impact on individuals who suffer from Myasthenia Gravis, an extremely rare bone marrow transplant has been performed by doctors at The Bone Marrow Transplant Program at University of California, San Diego Medical Center. This is the first time the operation has been attempted by any hospital in the western part of the United States.

The patient’s own immune system views itself as a foreign body and attacks itself in the case of Myasthenia Gravis. Of all the neuromuscular autoimmune diseases, it is one of the most rare. Making it impossible for the muscles to contract, the condition interrupts the normal transmission of nerve impulses to the muscles. Additionally, the muscles that control breathing can’t work right when the nerve impulses do not work right.

The Myasthenia Gravis Foundation of America believes the condition is very much under diagnosed and there are many individuals who do not know they have it opposing the statistics that state that 20 out of every 100,000 Americans have been diagnosed with MG.

The procedure gives patients purified blood forming stem cells after their existing stem cells are destroyed by chemotherapy. The immune system regains cells that do not attack the body after the modified transplant stem cells build new bone marrow, correct signaling pattern to the immune system.

Three prior procedures have been performed at the Northwestern University Hospital in Chicago. Dr. Martin Glasser, M.D., was the patient treated at UC-San Diego, marking the 4th procedure of this kind ever performed in history. At UCSD Medical Center, he has been receiving plasmapheresis treatments. Kidney failure patients go through a dialysis procedure, and plasmapheresis is similar. Over a short period of time, it can deliver benefit.

His bone marrow had to be obliterated in order to get him ready for the transplant. Most of the T cells in his body had to be destroyed. The theory is that new stem cells will not get the message to attack if the T cells are destroyed before the new stem cells are introduced. The immune system is renewed as the transplanted stem cells build new bone marrow.

8 million pure stem cells were yielded after 16 million cells were initially harvested and processed through a special filtering device. The stem cells have the best chance to produce a line of healthy blood cells when they are at this very early stage in their development. To protect against infection, patients are required to take antibiotics after the transplant is completed. Until the immune system is considered to be completely recovered, patients must maintain a strict diet and stay away from large crowds of people to avoid possible infection and illness. 3 months is the average amount of time predicted for this post transplant protocol.

Some tissue repair maybe happening to Dr. Glasser according to doctors. Feeling has returned to his feet following the transplant where he previously had no sensation.

The team who performed the operation was Ewa Carrier, M.D., Arnold Gass, M.D., professor of medicine at Veterans Affairs San Diego Healthcare System, Geoffrey Sheehan, M.D., UCSD professor of neurosciences and myasthenia gravis specialist and David Ward, M.D., UCSD professor of medicine and Apheresis program founder.

To find a superior treatment for juvenile diabetes, scientists have turned to a young boy.

Seven years ago, when Liam was born, his parents Steven and Beth opted to store his umbilical cord blood as an insurance to treat potential future illness. Now that Liam has diabetes, doctors have been injecting stem cells taken from the umbilical cord blood to try and slow, or possibly even stop, the progress of his diabetes.

For the national pilot study at the University of Florida, there are seven other children undergoing similar transplants using stem cells from their own umbilical cords.

Patients with juvenile diabetes, if left untreated, can fall into a coma or suffer kidney failure. Insulin-producing cells in the pancreas are destroyed by this autoimmune disease. More than 1.5 million Americans, including 125,000 children are afflicted with juvenile diabetes. Also known as type 1 diabetes, there is no cure for this disease.

Cancer and dozens of other blood disorders are regularly treated using stem cells taken from cord blood. Easily stored in blood banks, the stem cell rich cord blood can be extracted from the umbilical cord minutes after a baby’s birth.

The lead doctor in the study spends much of his time of the phone cautioning parents about keeping their expectations realistic due to the anticipation the stem cells can be successful in fighting juvenile diabetes.

“It’s important not to destroy their hope,” said Dr. Michael, a pediatric endocrinologist. “Everybody wants to cure diabetes. But this is a pilot study. It’s unlikely to be the Holy Grail.”

But it has helped Liam. His body is now fighting off the progression of the disease. His blood glucose levels decreased after the infusion. Prior to being injected, doctors were saying he would need regular injections of insulin because his blood glucose levels were rising.

A urine test detected excessive glucose in his system back in December, soon after the test, he was diagnosed with diabetes. Insulin, a hormone that regulates the body’s metabolism of carbohydrates, including glucose, was still being produced by his body in small quantities. This early diagnosis and circumstance is often called the “honeymoon” phase of the disease.

“There’s no magic pill to stop the process,” said Liam’s father, Steven. “As parents, you feel you’re helpless. You see what’s happening to your child.”

Surfing the web late on a December night, Liam’s mother discovered the Florida stem cell study while researching juvenile diabetes. She thought back to when Liam was born and remembered the cord blood bank that she paid to store his umbilical cord blood.

She enrolled her son in the four-year clinical trial.

“We feel God was with us,” she said.

Before taking Liam for his transplant at the university in Gainesville, the family visited the Kennedy Space Center and Sea World as a treat.

“You’ve got to have some sugar with your medicine,” Steven said.

Liam received the stem cells in an intravenous infusion after having some blood drawn. The procedure took only half an hour to complete.

To avoid rejection, Liam’s own cord blood needed to be used. There is a chance of rejection even with stem cells from a parent or sibling.

The clinical trial intends to enroll a total of 10 or more children. Currently there are five girls and three boys, all between the ages of 3 and 7.

The study requires using all of a child’s cord blood. This fact may deter some families because if the child gets another disease there won’t be any cord blood left to use. This will most likely change however, as storage facilities improve freezing and thawing processes that tend to destroy cells, and also begin keeping cord blood in more than one vial. Other methods of producing and preserving cells may also emerge.

At a cost of roughly $1,500, taking blood from a cut umbilical cord takes only a few minutes. A blood storage fee of $100 a year generally applies as well. Storage has become increasingly popular since blood banks began storing cord blood in the past decade. Most decide on the option in case a child or relative becomes ill.

Opposed to cells extracted from bone marrow, cord blood stem cells have more potential to develop into specialized cells needed to help a body fight disease. They are also easier to obtain than bone marrow cells and less controversial compared to those cells taken from human embryos.

The study at the university seeks to stop the autoimmune process but, “to cure diabetes, cord blood stem cells may be combined in the future with other medications, such as immune suppressant drugs, in a mix similar to “cocktails” given to cancer and HIV patients,” Dr. Michael stated.

Meanwhile, Liam’s parents are thankful to be able to hold off on having to give their son’s insulin shots.

“Liam should be getting worse, not better,” Steven said.

“You’re happy about that, right?” said Liam.

“We’re absolutely happy,” said his father, a medical equipment sales and service engineer.

Causes of the disease include genetic predisposition and other factors such as viruses or being overweight. Of the three siblings, two have diabetes, but their father does not.

“We’re not saying this is the end-all,” Beth said. “But it gives people hope. That’s why stem cell research is so important.”