Bioethics News

Boom in Unproven Cell Therapies Intensifies Regulatory Debate

September 7, 2016

(Nature) – 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.”

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