Thomas Albini met his first patient blinded by a stem-cell ‘treatment’ last year. The elderly woman, who had macular degeneration, thought she was paying to participate in a clinical trial that would save her sight by injecting stem cells into both eyes. Instead, it left her legally blind.

By the time Albini, an ophthalmologist at the University of Miami in Florida, had treated two more women who had been blinded by the same procedure, he knew that there was a systemic problem. Two of the women had been lured by a posting in a clinical-trial registry — even though there was no real trial to speak of — and none of the injections had been administered by a physician. The clinic offering the injections claimed that its procedure did not require approval from the US Food and Drug Administration (FDA), in part because it used the patient’s own cells. Altogether, Albini found the cases shocking. “Any sort of review would have been helpful.”

The debate over whether the FDA should review such treatments is growing more intense as purported stem-cell clinics proliferate across the United States. Current FDA regulations are poorly enforced and leave room for various interpretations. On 8 September, Albini will present his experiences at an FDA workshop. The following week, dozens of researchers, companies and patient advocates will flock to Bethesda, Maryland, for an FDA public hearing. Many of them will tout the virtues of unproven stem-cell therapies and insist that people should have the right to such treatments. The FDA has expanded the one-day hearing to two — and moved it to a larger auditorium — in response to overwhelming public interest.

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Image: By Wesley Fryer from Oklahoma City, Oklahoma, USA – Snake oil or Memory Elixer anyone?, CC BY 2.0, https://commons.wikimedia.org/w/index.php?curid=33792666

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