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.
The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion and analysis. Read full, original post: FDA weighs crackdown that could shut hundreds of stem cell clinics
