Diagnosed in 2005 with multiple sclerosis, Sam Herrell had few options available to him in the U.S., his home country. Now, however, he is traveling to Central America in order to receive an adult stem cell therapy that was pioneered by American doctors but which is not yet available within the United States.

A proud native of Texas, the Ennis Lions football coach has decided to travel to ICM – the Institute for Cellular Medicine – in Central America for treatment with his own adult stem cells. The ICM has an 80% success rate with its patients, but don’t expect the treatment to be available any time soon within the U.S., since the U.S. FDA (Food and Drug Administration) has made such a procedure legally impossible for doctors to conduct within the United States. Specifically, the FDA has decreed that autologous (in which the donor and recipient are the same person) adult stem cells must be classified and regulated as a "drug", and therefore cannot be used as a clinical therapy until first being subjected to the ordinary FDA laws that govern pharmaceutically manufactured drugs, which is a process that typically requires a decade or more of testing before approval can be obtained. Most patients, with multiple sclerosis as well as other diseases or injuries, cannot wait a decade or longer for treatment, so they are following the U.S. doctors who have set up their clinics outside of U.S. borders. If the FDA would only change their stance on this critically important issue, then the U.S. doctors who pioneered this adult stem cell treatment would be able to administer the therapy within the U.S., and then perhaps there wouldn’t be such an endless debate over embryonic stem cells, which still have years if not decades left before they could be considered for use in clinical therapies. Unlike embryonic stem cells, adult stem cells are already being used in clinics around the world to treat real people with real diseases – but not within the U.S., except for the very limited number of FDA-approved clinical trials that are being conducted.

As Sam Herrell explains, "The thing that’s kind of disappointing is that the neurologists here have nothing that really gives you much hope. All they can do is say keep on this medication and hope it slows down, hope it doesn’t overtake your whole nervous sytsem before they find a cure. Outside the U.S., some things are being done that people have had phenomenal results with, and that’s been encouraging. I really think there’s going to be a cure for it – that’s what I’m hoping for. It’s been encouraging to hear those stories and talk with people."

A number of scientific studies in the medical literature support such claims, not the least of which is an article that was published in the Journal of Translational Medicine in April of 2009, entitled, "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., in which scientists and doctors elucidate the various cellular and molecular mechanisms that are at work when this type of autologous adult stem cell therapy is implemented as a treatment for multiple sclerosis. Additionally, 3 case studies are described in the paper in which patients with multiple sclerosis showed significant improvement after receiving such a treatment. Of particular significance are the unique immunomodulatory properties of this therapy, which play an especially vital role in a disorder of autoimmune origin such as multiple sclerosis.

In specific reference to ICM, Mr. Herrell adds, "I’ve heard of two different procedures I really think I’ll try. It’s very expensive, but that’s a hurdle I can try to tackle for hope of a cure. I get excited when I talk to those people who have gone outside the country, because they’ve come back with a story of hope. I’m still hopeful for a cure. I’m serious about that. These people who have tried some of these things, they don’t feel better, they feel cured. That’s what I’m hoping for. Then I can still live in Texas."

However, the U.S. FDA still insists that the cells within a person’s own body are "drugs" and therefore cannot be administered, not even to that very same person, for therapeutic purposes until first being subjected to the exact same multi-year, multi-million dollar approval process by which the pharmaceutical industry is regulated. Unless the FDA ever changes its position on this issue, people such as Sam Herrell will be forced to travel outside of the U.S. in order to be treated with their own, autologous adult stem cells.

Fortunately, at least such therapy does exist somewhere in the world, even though not in the United States.

In order to treat her multiple sclerosis, Ann Lacy is traveling to a clinic in Central America for adult stem cell therapy. Currently she is in the process of raising approximately $35,000 for her trip, which will cover not only the cost of the therapy itself but also related travel expenses. The therapy is not eligible for insurance coverage, even though this particular clinic, the Institute for Cellular Medicine (ICM), boasts an 80% success rate in treating its patients.

The reporter for this particular news report as it appeared in the Tri County Leader states that, "The treatment has not been approved by the U.S. Food and Drug Administration, and studies on the effectiveness of this therapy are virtually nonexistent."

In fact, while the first half of that sentence is true, the second half is not. Numerous studies have already been reported in the medical literature which do, indeed, document both the safety and the efficacy of this therapy, such as, for example, the article entitled, "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., which was published in the Journal of Translational Medicine on April 24, 2009 and which meticulously documents 3 clinical case reports of multiple sclerosis patients who were treated with this type of autologous adult stem cell therapy and who subsequently showed dramatic improvement. Additionally, numerous other reports in the conventional, peer-reviewed medical literature also exist on the topic of adult stem cells, especially mesenchymal stem cells, as a treatment for multiple sclerosis, which any simple search of the medical literature would immediately reveal. To say that "studies on the effectiveness of this therapy are virtually nonexistent" is merely to advertise one’s ignorance of the topic, since such a statement is egregiously false.

The first half of the sentence, unfortunately, is very true: namely, such therapies have not been approved by the U.S. Food and Drug Administration. The FDA approval process is notoriously a very lengthy and expensive one, typically lasting a decade or longer and costing millions of dollars, even under the best of circumstances. In this particular instance, however, the prospect of ever getting autologous (in which the donor and recipient are the same person) adult stem cell therapy approved by the FDA is further complicated by the fact that the FDA has specifically outlawed such a procedure in the United States. In other words, the FDA has decreed that each person’s own endogenous, naturally occurring adult stem cells are "drugs" and therefore must be regulated as such, and therefore cannot be clinically administered as therapies in the U.S. – not even to the same person from whom the cells were obtained – until having first been subjected to the multi-year, multi-million dollar federal governmental approval process. It is this stance by the FDA on autologous adult stem cells – not any restrictions on the federal funding of embryonic stem cell research – which is the primary obstacle to stem cell therapies in the United States. Human embryonic stem cell (hESC) research has continued in previous years with private funding, yet hESCs still have at least another decade to go before they can be considered safe enough for clinical use, according to expert consensus among the hESC scientific community. Meanwhile, adult stem cell therapies are already in use throughout the world, in almost every country except the U.S., because of this ruling by the U.S. FDA. Only in the U.S. are a person’s own tissues and cells considered to be "drugs".

A number of grass-roots organizations have been formed in response to the FDA’s stance, which include the physician-based American Stem Cell Therapy Association (ASCTA) and the patient-based "Safe Stem Cells Now!". More information on these organizations is available at their websites, www.stemcelldocs.org and www.safestemcells.org, respectively.

As Dr. Christopher Centeno, founding CEO of the adult stem cell company Regenerative Sciences, and one of the founders of the ASCTA, has stated, "While the Obama administration seems to have opened the embryonic stem cell door, their FDA seems to want to slam the adult stem cell door shut."

(Please see the related news articles on this website, entitled, "Arizona Man Travels to Central America for Adult Stem Cell Therapy", dated July 16, 2009; "Bangor Family Heads to Central America for Adult Stem Cell Therapy", dated July 8, 2009; and "Two U.S. Adult Stem Cell Companies Form Collaboration in Asia", dated May 11, 2009).

Judy DiCorcia of New York has written an open letter to President Obama in which she describes the improvement of her 10-year-old autistic daughter, Lauren, after adult stem cell therapy was administered to the child at the XCell-Center in Cologne, Germany.

The treatment, which cost approximately $10,000, took place in January of this year and consisted of a simple procedure in which adult stem cells were extracted from the girl’s own bone marrow and then readministered via a lumbar puncture in the girl’s spine. The technique was quick, simple and minimally invasive.

According to the girl’s mother, Lauren has shown significant improvement in a number of ways, including being able to sleep through the night for the first time in the girl’s life. Not quite half a year after the treatment, Ms. DiCorcia now reports that "Lauren is doing well. I would have to say that she plateaued at about the 12-week mark. Her situation is stable and fortunately all positive effects have persisted. I wish the doctor could fly to the U.S. and perform the therapy here!"

The XCell-Center is a private clinical group and institute for regenerative medicine which operates two treatment centers, one in Cologne and one in Dusseldorf, Germany. It is the first privately owned medical center in Europe to specialize in regenerative medicine. In addition to providing autologous adult stem cell therapies to patients, the XCell-Center is also actively involved in pre-clinical and clinical research. Since January of 2007, more than 1,600 patients have been treated with their own adult stem cells at the XCell-Center.

As stated on their website, the XCell-Center "is the first private institute worldwide to hold an official license for the extraction and approval of stem cell material for autologous treatment." Since only adult stem cells are used at the XCell-Center, not embryonic stem cells, the treatments are ethically noncontroversial and scientifically proven to be medically safe. Since only autologous (in which the donor and recipient are the same person) adult stem cells are used, there is no risk of immune rejection. The XCell-Center operates in full accordance with German law and European guidelines. The specialized team of physicians at the XCell-Center includes neurosurgeons, cardiologists, hematologists, orthopedists, radiologists and pharmacologists. In addition to autism, the XCell-Center also treats a number of other medical conditions which include stroke, cerebral palsy, spinal cord injuries, orthopedic injuries, ischemic heart disease, peripheral artery disease, diabetes and complications thereof, multiple sclerosis, Alzheimer’s disease, Parkinson’s disease and other degenerative illnesses.

The XCell-Center boasts an international advisory board and is a member of the German Society for Regenerative Medicine. Its headquarters are located at the Dominikus hospital in Dusseldorf, while its second branch is located at the Eduardus Hospital’s Institute of Regenerative Medicine in Cologne.

As explicitly stated on the website of the XCell-Center, "therapy with embryonic stem cells is strictly prohibited in Germany. At the XCell-Center, we only use the patient’s own stem cells for therapy." The strict prohibition of embryonic stem cell therapy in Germany, as in many other countries, is based not so much on ethical concerns but on concrete scientific reasons, not the least of which is the fact that embryonic stem cells are medically unsafe. In addition to causing teratomas (a specific type of tumor), embryonic stem cells are notorious for their numerous other inherent problems which disqualify them for any type of clinical therapeutic use.

Back in the U.S., Lauren’s mother, Ms. DiCorcia, wishes that this type of adult stem cell therapy were available in the U.S., so that she wouldn’t have to travel to Germany for her child’s treatment. Unfortunately, however, adult stem cell therapies, such as these that are being used with such success in Germany, which already exist and which are already being used in clinics around the world, would be available in the U.S. were it not for the fact that the FDA (Food and Drug Administration) has outlawed such therapies by designating each person’s own adult stem cells as a "drug" which therefore must be regulated by the same laws that apply to the giant pharmaceutical companies that manufacture prescription medication. Consequently, it is this stance by the FDA which is forcing all adult stem cell physicians to relocate outside of the U.S., where they set up their clinics in any and every other country on earth except the United States.

Ms. DiCorcia’s open letter to the President of the United States is reproduced herein:

"Dear President Obama,

I am the mother of a 10-year-old autistic daughter. In January, we took Lauren to Cologne, Germany for adult stem cell therapy. The center used her own stem cells drawn from her hip bone marrow, centrifuged the next day, and then reinserted via lumbar puncture the following day (2.95 million cells). Both procedures were quick and not invasive at all. In the past 6 weeks we have seen significant improvements in our daughter’s behaviors, focus, hyperactivity, and insomnia. I would rate a general improvement of about 40% – this is HUGE for a family living with autism. Our daughter started sleeping through the night for the first time (yes, she is 10 and got up every night) since stem cells. Lauren is happier just in her own skin – so much less frustrated and just generally happier. She is getting through her one-on-one therapy more quickly, better focused, and more compliant. Of course, it amazes me that this simple, non-controversial therapy cannot be done here in the United States.

Sincerely,

Judy DiCorcia"

The biotech company Pluristem Therapeutics, formerly known as Pluristem Life Systems, has been granted patent # 7,534,609 for a method of expanding undifferentiated hemopoietic stem cells.

Pluristem Therapeutics specializes in the development and commercialization of allogeneic (in which the donor and the recipient are not the same person) cellular therapy products derived from the human placenta for the treatment of severe ischemic autoimmune disorders such as multiple sclerosis, peripheral artery disease, ischemic stroke, inflammatory bowel disease including Crohn’s disease, and others. The company’s proprietary technology includes a 3D bioreactor, PluriX, which simulates the microenvironment of bone marrow substrates for the large-scale culturing and three-dimensional expansion of stromal cells without the need for supplemental growth factors or other exogenous materials. The cells generated by PluriX, known as "PLX" (PLacental eXpanded) cells, not only possess "immune privileged" properties but also immunomodulatory properties as well, and are expandable in vitro without exhibiting phenotypic or karyotypic changes. This new patent, however, was awarded to Pluristem for an invention involving methods and materials by which undifferentiated hemopoietic stem cells may be expanded in a novel type of bioreactor which is separate and distinct from the PluriX.

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 human 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 the PLX 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 risky supplemental growth factors nor other exogenous materials. As adult stem cells that are derived from the human placenta, which is an extremely rich source of non-embryonic stem cells, ASCs are also ethically non-controversial in addition to being highly potent adult stem cells.

As stated on Pluristem’s website, "The Company has made a strategic decision to work only with adult stem cells since the practical use of embryonic stem cells is severely restricted by various religious, ethical and legal considerations."

In a manner which is similar to that by which the PluriX bioreactor three-dimensionally expands ASCs into PLX cells, the new invention allows undifferentiated hemopoietic cells to be expanded three-dimensionally upon stromal feeder cells, without undergoing differentiation. At least theoretically, such a bioreactor could be adapted to any type of cell, and a reviewer of the patent in StemCellPatents.com suggested the applicability of the bioreactor to the expansion of embryonic and iPS cells.

In separate though related news stories, earlier this year Pluristem received approval to begin clinical trials for the treatment of critical limb ischemia with its proprietary adult stem cell product PLX-PAD, an allogeneic placental-derived stromal cell product. In May of 2009, Pluristem also announced the selection of a major clinical site in North Carolina for the PLX-PAD Phase I clinical trial, which will be conducted at Duke University Medical Center. According to Zami Aberman, president and CEO of Pluristem, "We are very pleased to be working with Duke University Medical Center on the Phase I clinical trial using our PLX cells and believe that being involved with such a prestigious, reputable institution emphasizes the important therapeutic future for our mesenchymal-like stem cells."

According to Duke University cardiologist Dr. Robert Mitchell, the principal investigator for the PLX-PAD trial, "We look forward to collaborating with Pluristem in studying this interesting potential approach to dealing with limb ischemia. This is an oftentimes devastating disease and beginning the process of understanding the action of these cells in a Phase I clinical trial is an important step forward."

In the U.S. alone, it has been estimated that as many as 12 million people suffer from critical limb ischemia (CLI), an advanced form of peripheral artery disease (PAD) that is associated with high rates of morbidity and mortality, often resulting in amputation and frequent hospitalization. Although standard medical therapies are currently ineffective in treating CLI, the market value for an effective CLI therapy has been projected to be over $1 billion. For the first time, cell-based therapies such as Pluristem’s PLX-PAD offer a potentially safe and effective treatment of a life-threatening medical condition which previously has been incurable.

In addition to its cell-based therapy for CLI, Pluristem is currently developing other adult stem cell products for the treatment of other degenerative, malignant and autoimmune disorders. The company’s first product, PLX-BMT, was directed at improving the engraftment of hematopoietic stem cells derived from umbilical cord blood as an alternative to bone marrow transplantation.

Although the company’s most recent patent, for a method of expanding undifferentiated hemopoietic stem cells, was awarded on May 19, 2009, the patent application was originally filed on April 11, 2005, at which time the company was known as Pluristem Life Systems. On November 26 of 2007, however, corresponding to a reverse stock split and the designation of a new ticker symbol, the company also announced the official change of its name to Pluristem Therapeutics.

(Please see the related news article on this website, entitled, "Pluristem to Begin Adult Stem Cell Clinical Trials for Critical Limb Ischemia", dated January 13, 2009).