Search Results for: hiv

Why did Duke autism team halt its troubling pay-for-play program?

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 …

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Weekly reads: oocytes from males, David Sinclair longevity inc, diabetes, He Jiankui

David Sinclair

A team led by Harvard professor David Sinclair had a recent Cell paper on reprogramming to fight aging that I reviewed here on The Niche. I thought the paper was exciting and important. Note that in vivo reprogramming was first done more than a decade ago. Sinclair did have a novel fast-forward aging method and overall …

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WHYY oh WHYY: NPR puff piece on risky stem cell microneedling

I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling.  Is this journalism or product promotion? The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How …

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Does Medicare cover stem cell therapy? Mostly no & it’s poised to recoup tens of millions

Regenative labs, does Medicare cover stem cell therapy?

Does Medicare cover stem cell therapy? Readers of The Niche have regularly asked this question. They’re curious about insurance coverage too. The answer is “no” in almost every case, with some notable exceptions I’ll get to at the end of the post. Still, clinics appear to have already been charging Medicare for what collectively adds …

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Grading my 2022 regenerative medicine predictions

stem-cell-crystal-ball-300x3001

It’s that time of year again when I grade my previous year’s predictions for the stem cell & regenerative medicine space. Overall, I did better than a typical year. I give the 2022 predictions an A- overall. This exercise can be kind of fun but also humbling. For example, I tend to be too optimistic …

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He Jiankui says he’s back in the lab after prison for CRISPR babies

He Jiankui

Earlier this year Chinese researcher He Jiankui finished his prison sentence. When I saw that news I wondered about the next chapter for him. It seems he’s already back in the lab doing genetics research. At least that’s according to a blog by He Jiankui himself. Can we trust that what he has written on his website is …

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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

Former FDA Commissioner Stephen Hahn.

An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …

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Paper sparks renewed interest in transdifferentiation & clinical potential

transdifferentiation, iOPCS

There was a time when I thought transdifferentiation based approaches might quickly move into clinical trials. Then things kind of cooled off. We didn’t see many papers reporting methods to transdifferentiate cells. I still think that this technology, sometimes called direct reprogramming, has major potential. A new paper on making human brain cells this way got …

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End of FDA “grace period” impacted perinatal cell therapy biotechs

knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …

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