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Earlier this year, doctors reported the case of three women who went blind after having stem cells derived from their own fat injected directly into their eyeballs—a procedure for which they each paid $ 5,000. Piecing together how those women came to pay for such a treatment, the doctors noted that at least one of the patients was lured by a trial listing on ClinicalTrials.gov—a site run by the US National Institutes of Health to register clinical trials. Though none of the women was ever enrolled in the trial—which never took place and has since been withdrawn—it was enough to make the treatment seem like part of legitimate, regulated clinical research.
But it wasn’t. And, according to a new analysis in the journal Regenerative Medicine, it’s not the only case of dubious and potentially harmful stem cell therapies lurking on the respected NIH site.
At least 18 ostensible trials listed on the site offer similar stem cell treatments that participants must pay to receive—unlike most trials, which compensate rather than charge participants for experimental treatments. These trials, sponsored by seven companies total, claim to be developing therapies for a wide range of conditions, like erectile dysfunction, type II diabetes, vision problems, Parkinson’s disease, premature ovarian failure, and chronic obstructive pulmonary disease (COPD). However, these trials are largely not backed by preliminary research. None of them has Food and Drug Administration approval—even though the agency has published a draft guidance that suggests these treatments are subject to FDA regulation. And some of the studies are only granted ethical approval by review boards with apparent conflicts of interest and histories of reprimands from medical boards and the FDA.
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