In 2003, Mark Palmer was paralyzed from the chest down in a car accident. Now 29 years old, he is currently spending a month in Central America where is he is undergoing adult stem cell therapy.
His wife, Celeste, read about the clinic at ICM – the Institute for Cellular Medicine – which boasts an 80% success rate with its patients. Along with a local charity called Positive Impact, friends and family helped Mark and Celeste raise approximately $30,000 for trip, which includes the cost of the treatment itself as well as related travel expenses.
Currently, adult stem cell therapy is not available in the U.S., despite its wide availability overseas, due to a number of legal reasons which include a lethargic and outdated regulatory system in the U.S. which is in urgent need of reform. Among other problems, the U.S. FDA (Food and Drug Agency) has decreed that each person’s own endogenous, naturally occurring adult stem cells are a "drug" and therefore must be regulated according to the same laws to which pharmaceutical companies must conform. In other words, the FDA has outlawed the use of autologous adult stem cell therapies in the U.S., thereby forcing an increasing number of U.S. adult stem cell companies and physicians to take their business overseas. Only in the U.S. are a person’s own cells considered to be a "drug", with the hardly surprising result that people can obtain adult stem cell therapies just about anywhere at all in the world, except in the United States, which is especially ironic since most of the adult stem cell therapies that exist throughout the world were pioneered either in the United States or by U.S. researchers who have been forced to conduct their research outside of the United States.
A prime example of this legislative dead-end involves the adult stem cell company known as Regenerative Sciences, which found itself at the center of this controversy when, in July of 2008, the founding CEO of the company, Dr. Christopher Centeno, received a letter from the FDA stating that the autologous adult mesenchymal stem cells processed in the company’s prioprietary procedure, Regenexx, are considered to be "drugs" since they are intended for therapeutic use. In the letter, the FDA stated that, "These cells are considered drugs because the therapeutic claims shown on your website demonstrate that they are intended for use in the diagnosis, cure mitigation, treatment or prevention of disease in man." The letter concluded by stating, "Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations… The mesenchymal stem cells utilized in your Regenexx procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in the FDA seeking relief as provided by law."
Regenerative Sciences responded by posting the following notice on their website, which was most recently updated on March 31, 2009: "Last summer we got a letter from the FDA stating that they felt that our Regenexx medical procedure was actually the manufacturing of a new drug. The letter made no sense, as what we’re doing is practicing medicine. We kindly wrote back stating our position and then we didn’t hear back for more than half a year. Recently, the FDA has again asserted that they believe we are manufacturing a drug. They haven’t given any credible rationale for why they believe this, as what we’re doing with adult stem cells is no different than the average fertility clinic that grows embryos in culture for re-implantation. The fertility clinic is not regulated as a drug manufacture facility. The fertility specialists fought that fight and won."
This is a critically important issue, since it illustrates the frustration that many, if not all, adult stem cell scientists in the U.S. feel, as it this stance by the FDA which poses an insurmountable, not to mention entirely illogical, hindrance to the clinical use of adult stem cell therapies in the United States. For anyone who has ever wondered why it is that adult stem cell therapies are available in ordinary clinics in most countries outside of the U.S., but only in a limited number of FDA-approved clinical trials within the U.S., here’s your answer: the FDA considers each person’s own autolgous adult stem cells to be a "drug", and therefore those stem cells are subject to the same multi-year, multi-million-dollar clinical trial process through which all pharmaceutically manufactured drugs must pass before being considered legally marketable within the United States.
A number of grass-roots organizations have been formed, therefore, in order to combat this antiquated stance by the FDA. As the statement on the website of Regenerative Sciences continues: "ASCTA (American Stem Cell Therapy Association) is a physician organization that was formed in opposition to the FDA’s position that adult stem cells are drugs. This group heralds a much bigger movement than what we’re doing here with the Regenexx procedure. We’ve found literally an outcry by patients with chronic diseases that the FDA would stand in their way of getting safe stem cell work performed by their doctors. We agree that there are hundreds of likely unsafe stem cell outfits around the globe injecting God-knows-what into whoever has the will to pay. All the more reason for an organization to step to the forefront to establish physician-run guidelines for safe lab practices and clinical oversight… The pre-clinical research on adult stem cells is much stronger than embryonic stem cells… When I’ve posed the question to numerous doctors and experts in the field, are your own stem cells drugs? They look at me like I’m crazy, and often reply ‘Of course my stem cells aren’t drugs!’ Why would the FDA take the position that your cells are drugs… The ASCTA physician group will be getting out its lab practices guidelines meant to hold new adult stem cell practices to the highest standards to protect patients. Our goal is clear and it’s worth fighting for: Safe Stem Cells Now!"
Likewise, the ASCTA has posted the following statement on their website: "The American Stem Cell Therapy Association (ASCTA) announced today the online publication of its mission statements and charter. The organization was formed in response to the Food and Drug Administration’s (FDA) recent position that the adult stem cells found in everyone’s body are drugs, a position the ASCTA opposes. This physician organization is establishing laboratory guidelines that will allow doctors to bring adult stem cell therapy to their patients more quickly. These guidelines will be similar to those used by fertility specialists in in-vitro fertilization (IVF) labs, where many of the same cell culture techniques are used."
Dr. Centeno, one of the founding members of the ASCTA, is quoted on the ASCTA’s website where he states, "Many patients are dying or suffering daily with incurable diseases or problems that require major surgery. These patients should have access to basic adult stem cell therapy now. ASCTA is establishing guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors." According to Dr. Frank Falco, another ASCTA founding member who is also quoted on the ASCTA’s website, "The FDA’s position against someone using their own stem cells is taking it too far. We are talking about a person using their own tissue to treat a degenerative disorder or process safely without the use of medications or surgery. Although we agree that oversight and standards are necessary, this should be provided through a physician organization such as ASCTA rather than by a government agency."
Not all stem cells are created equal, of course, and it is vitally important that the FDA make distinctions between embryonic, fetal and adult stem cells. In this regard, the ASCTA website continues, "Adult stem cells are different than embryonic stem cells. Adult stem cells are found in the patient’s body in various tissues. In order to obtain enough stem cells for treatment, they often need to be cultured, similar to today’s fertility treatments. Adult stem cells have undergone much more research than embryonic stem cells and therefore are closer to real world treatments. These adult stem cells are taken from the patient’s own body (autologous) and ASCTA believes that they are therefore the safest for use in treating patients." To this Dr. Centeno adds, "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."
As also stated on their website, "The ASCTA is a physician group comprised of various medical and surgical specialists whose goal is to bring safe stem cell therapy to patients by establishing laboratory and clinical guidelines." More information is available at www.stemcelldocs.org.
Additionally, in April of 2009 a patients’ movement called "Safe Stem Cells Now!" was formed in response to the FDA’s unfounded position that a person’s own adult stem cells are "drugs" and therefore should be regulated in the same manner. More information about this organization is available at www.safestemcells.org.
As Barbara Hanson, cofounder of www.stemcellpioneers.com, states, "Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others."
Indeed, many people feel that this stance by the FDA is purely politically and economically motivated. At the very least, it is an entirely unscientific stance, and it is merely one example of the numerous ways in which the FDA needs to update its regulations so that these regulations are relevant and applicable to stem cells, which do not fall into any of the previously existing categories for which the FDA has ever had to formulate national law in the past. Such outdated laws are precisely what is driving many of the best and most accomplished adult stem cell physicians and scientists "off-shore", to set up their laboratories and clinics anywhere at all in the world, just as long as it is outside the borders of the United States. In the end, it is the U.S. patient who suffers, since the researchers and clinicians themselves are not stopped but are merely forced to relocate to other countries. Until the FDA is able to recognize the numerous and vast differences between an autologous adult stem cell and a pharmaceutically manufactured drug, it is no wonder that so many American adult stem cell companies and clinics can be found everywhere throughout the world, except in their own home country, the United States.
Hopefully, someday, the FDA might update its rules and regulations to match the pace of scientific discovery, at which time it might be possible for U.S. citizens such as Mark Palmer to receive adult stem cell therapy in their own home towns, in their own country, without having to travel to foreign countries. Meanwhile, however, at least such therapy is available somewhere, at clinics such as ICM, even if only outside of the United States.
(Please see the related news articles on this website, entitled, "Bangor Family Heads to Central America for Adult Stem Cell Therapy", dated July 8, 2009; "Texas Woman Travels to Central America for Adult Stem Cell Treatment", dated June 25, 2009; and "Two U.S. Adult Stem Cell Companies Form Collaboration in Asia", dated May 11, 2009).
