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).