The United States has arguably the most advanced health care in the world. Which is why I was surprised at how many Americans are going abroad for stem cell treatments using their own adult stem cells.
This is called an autologous stem cell transplant. I read nearly everyday about patients going to China, India and Germany to get treated for anything from spinal cord injuries to autism. It has even been reported that Peyton Manning went to Europe recently to get a stem cell treatment for his neck. I also have read about patients who reside in these countries getting treatments for brain injury to type II diabetes with impressive results. The Repair Stem Cell Institute which refers patients to what they say are reputable stem cell treatment centers around the world has a list of diseases being treated with autologous stem cell transplants that is a mile long.
Remember, these are not cures, but therapies aimed at improving the symptoms of the disease and the quality of life for the patient. It is also important to point out that these are not the stem cell treatments that have recently been in the news where patients have received stem cells from embryos or fetuses. These are stem cell transplants using a patient’s own stem cells.
So why is this autologous stem cell tourism happening? Many ask why are these treatments not available in the United States? It is often wrongly suggested that it has to do with Bush’s restrictions on the funding of embryonic stem cell research. It has absolutely nothing to do with that because these are autologous adult stem cell transplants. In reality, unlike the United States, most industrialized nations have some kind of legislation that protects embryos from being created and destroyed for research.
The real answer is simple: because of the U.S. Food and Drug Administration or FDA. The FDA has categorized an autologous stem cell transplant as it would a drug and therefore autologous stem cell transplants must go through the same rigorous phase trials that a new drug would. From the FDA Regulation of Stem-Cell–Based Therapies in the New England Journal of Medicine:
Any stem-cell–based product that contains cells or tissues that “are highly processed, are used for other than their normal function, are combined with non-tissue components, or are used for metabolic purposes” — and that includes most, if not all, of them — would also be subject to the Public Health Safety Act, Section 351, which regulates the licensing of biologic products and requires the submission of an investigational new drug application to the FDA before studies involving humans are initiated.
So because stem cells would be removed from the body and “processed” with components not from the patient to get them to grow, the FDA has ruled that an autologous stem cell transplant is like a drug.
Of course, there are those who disagree with this assessment basically taking the stance that because the stem cells come from the patient, they should not be considered a drug. From a press release from the former American Stem Cell Therapy Association (ASCTA) which changed its name to The International Cellular Medicine Society (ICMS):
“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.” stated Christopher J. Centeno, M.D, an ASCTA physician member. “ASCTA is establishing guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors.” continued Centeno. Another ASCTA physician member, Frank Falco, M.D. stated, “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.”
Now, I want to make something clear. I am not a doctor so I am not qualified to speak on whether or not autologous stem cell transplants are safe or whether the FDA regulations are appropriate. I am not advocating either position, I simply want my readers to understand the reasons why the United States is not offering the same adult stem cell treatments as other countries around the world and why American patients are seeking adult stem cell treatments elsewhere.
LifeNews.com Note: Rebecca Taylor is a clinical laboratory specialist in molecular biology, and a practicing pro-life Catholic who writes at the bioethics blog Mary Meets Dolly. She has been writing and speaking about Catholicism and biotechnology for five years and has been interviewed on EWTN radio on topics from stem cell research and cloning to voting pro-life. Taylor has a B.S. in Biochemistry from University of San Francisco with a national certification in clinical Molecular Biology MB (ASCP).