A new study published in the journal Cell Stem Cell warns that unregulated and unsafe stem cell therapies are being employed in clinics throughout the United States. The findings refute the commonplace narrative of so-called “stem cell tourism,” which involves patients crossing borders to seek treatment that is of highly questionable merit. Instead, hundreds of U.S. facilities are engaged in direct-to-consumer marketing of stem cell interventions, with particular proliferation in California (113 clinics) and Florida (104 clinics).
The news comes even as tremendous leaps are being made in the safe and effective use of stem cells in variety of treatments. Also this week, the journal Neurology published a study providing new evidence that injecting human stem cells into the spinal cord may eventually be a pathway to slowing the progress of amyotrophic lateral sclerosis (ALS) in patients. Though it stirred a great deal of hope and excitement, the report in Neurology also emphasizes caution and acknowledges the delicacy and risk of such procedures.
The natural worry is that the abundance of businesses marketing unproven stem cell therapies as a miraculous panacea will undermine the perceived value of researchers who are moving with a more ethical incrementalism in the development of treatments. That dilemma will only increase as more horror stories of dire outcomes get extensive press coverage, such as the recent New York Times piece on a patient who sought stem cell therapy in Mexico, resulting in the development of a tumor that has flummoxed doctors and left him paralyzed.
The study in Cell Stem Cell, authored by Leigh Turner and Paul Knoepfler, speculates that the relatively slow movement towards regulatory oversight has contributed to the problem, a concern that has been raised previously. They write, “Given that we identified 351 businesses actively advertising stem cell products in the U.S., it is fair to ask whether regulatory inaction has emboldened entrepreneurial physicians and other market participants. We place a high value on the imperative to provide patients with safe and efficacious interventions and see a need for more effective regulation of the U.S. marketplace for stem cell interventions.”
Filed Under: Industry regulations