Viewpoint: US government’s clinical trial registry plagued by ‘bogus’ patient-funded stem-cell trials

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Image: Elena PavlovicH/shutterstock

When a judge ruled [June 3] that the FDA could stop the work of U.S. Stem Cell, the firm’s trials remained on clinicaltrials.gov; the postings were no longer actively enlisting patients, but they didn’t mention that the company’s injections had blinded at least four people, either.

Nor did a listing of a completed study sponsored by Cell Surgical Network include any indication that the FDA is seeking an injunction against that company, too.

“You can concoct this bogus appearance of science, call it a clinical study, recruit people to pay to participate in your study, and not only that: You can actually register on clinicaltrials.gov and have the federal government help you promote what you’re doing,” said University of Minnesota bioethicist Leigh Turner.

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That’s why Dennis Clegg, who studies stem cell-based eye therapies at the University of California, Santa Barbara, has stopped referring people to clinicaltrials.gov. “I used to tell people all the time, ‘Go to clinicaltrials.gov, and you can see what’s going on,’” he said. “But if they’re listing the so-called patient-funded research, where patients have to pay $5,000 or $10,000 … now the best advice I can give is, ‘Talk to your ophthalmologist.’”

Read full, original post: Stem cell clinics co-opt clinical-trials registry to market unproven therapies, critics say

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