Why Don’t Patients Stay in the U.S. for Stem Cell Treatments?

Bioethics   Rebecca Taylor   Aug 1, 2012   |   3:08PM    Washington, DC

The United States has arguably the most advanced health care in the world. Which is why many Americans are surprised at how many of our fellow citizens are going abroad for stem cell treatments using their own adult stem cells. This is called an autologous stem cell transplant. So why is this autologous stem cell tourism happening and why are these stem cell treatments we keep hearing about not available in the United States?

Progressives often wrongly imply that it has to do with Bush’s restrictions on the funding of embryonic stem cell research. And since there is so much misinformation surrounding stem cell research, the public often believes that this is the case. In reality, this kind of stem cell tourism has absolutely nothing to do with that because these are autologous adult stem cell transplants not embryonic stem cell transplants.

The real reason is more complex than simple funding restrictions. It is 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.

Others 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.”

A U.S. District Court has now ruled that the FDA has the authority to regulate clinics in the U.S. that are offering autologous stem cell transplants. From New Scientist:

It’s official: stem cells are drugs. At least, that’s the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice – not regulated by the US government. But if the cells are subjected to more than “minimal manipulation”, the FDA maintains that the therapy becomes a “drug”, which must be specifically approved for use.

It was on this basis that in 2008 the FDA began moves to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx.

Regenerative Sciences challenged the FDA’s authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court’s ruling.

Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. “This is really round one,” he says. “Our position remains that a patient’s cells are not drugs.”

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I am not a doctor and am not qualified to comment on whether the FDA policy is reasonable or whether the court made the correct ruling, but I can say that this is an important decision. On one hand, it may prevent charlatans with too-good-to-be-true claims from preying on sick Americans. On the other hand, it means that autologous stem cell transplants with potential to help patients will have to go through years of trials, just like drugs, to get FDA approval.

If nothing else, readers should be aware of the FDA policy so that next time someone wrongly states that Americans are going elsewhere for stem cell treatments because of Bush’s funding restrictions on embryonic stem cell research, you can correct them.