Scientists on [Sept. 12] will urge the Food and Drug Administration to crack down on rogue clinics across the country that market stem cell treatments for…[an] array of ailments from autism to paralysis to erectile dysfunction.
But the move comes at an awkward time — because research on stem cell treatments is just starting to bear fruit.
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Academic researchers will be left to walk a delicate line: Acknowledge the progress they’ve made in developing stem cell therapies — and then make the case that such treatments aren’t yet ready for prime time, and especially not in for-profit clinics.
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But safety concerns have spiked — some patients have gone blind after treatment, and others have developed tumors — so the FDA is now proposing to regulate the cells as drugs, meaning clinics would have to go through a costly and rigorous approval process before treating patients.
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Critics fear that even if FDA does classify stem cells as drugs, it will be difficult for the chronically understaffed agency to force the closure of hundreds of clinics.
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