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The Niche
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Stem Cell & Regenerative Med Newsletter
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Weekly reads: FDA nod on new cell therapy, gray hair, pong-playing cells
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It's a big challenge to get a cell therapy approved by the FDA and if you look at my list of FDA-approved stem cell therapies, it's not as long as we might hope. FDA OK on cell therapy from Gamida Cell For this reason, it was excellent news to see that the FDA approved a new cell therapy. Here's some …
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Why did Duke autism team halt its troubling pay-for-play program?
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Almost two years ago I publicly called on the FDA to freeze the unproven cord cell expanded access program (EAP) at the Duke Autism Center. Duke has been infusing kids with autism spectrum disorder (ASD) with unproven cord cells and requiring large payments for this. The cost was as much as $15,000. A halt and a mystery The Duke team led …
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