It’s surprising how many Americans are going abroad for autologous stem cell treatments (using cells from a patient’s own body not embryonic stem cells). Why are autologous stem cell treatments not available in the United States?
The reason is the U.S. Food and Drug Administration categorized an autologous stem cell transplant as it would a drug. Therefore autologous stem cell transplants must go through the same rigorous phase trials that a new drug would which has added years to the approval process. Some experts feel it will take from 7 to 10 years before this will occur in the United States.
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” 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.”
While this is the FDA’s ruling on autologous stem cell transplantation, others disagree with this assessment. Their view is because the stem cells used in this procedure are the patient’s own cells, removed from the patient, treated and then replaced in the same patient, they should not be considered a drug.
From a press release from the American Stem Cell Therapy Association (ASCTA):
“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.”
While the FDA continues it’s rigorous phase trials of autologous stem cell transplantation therapy, the only choice patients have who would benefit from treatment is to go outside of the United States to receive it.