Search Results for: fda

Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs

CRISPR-baby

If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with …

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Turner pub charts runaway stem cell clinic industry; FDA needs to think big now

U.S. Stem cell clinics map 2021.

Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging. He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016. I’m very glad that Leigh has continued this line of …

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Weekly stem cell reads: pending FDA verdict, blood vessels, RA

Cellular populations in the vascular wall, stem cell niche

Any day now we should get the verdict from the judge in the big stem cell clinic case here in California against Cell Surgical Network, et al. It seems that the FDA is waiting on this verdict before taking some major actions. If the judge rules against the agency it could throw the area into …

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Weekly reads: New FDA guidance, brains, MSCs, senescence

human mouse marmoset brain

This week marked the release of new draft FDA guidance on cell and gene therapies. Is the FDA kind of like the guidance counselor at school or more like the principal? It probably depends on many factors. I also find it funny how pretty much everyone in academia and biotech industry works to be compliant …

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Weekly reads: news, legos for stem cells, FDA, cancer, more

Legos for stem cells Fig 1b

I’ve been busy recently focusing more on grant and paper writing than reading papers on stem cells, but my piece on trying to de-extinct mammoths via cloning-like methods drew strong opinions on both sides. Recent news and resources on stem cells We’re still awaiting a verdict in the big California federal court case where the FDA is …

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FDA should freeze Duke EAP & probe $58 million Cryo-Cell deal linked to it

cryo cell infusion clinic marketing

I recently found concerning SEC filings from the biotech Cryo-Cell about a deal it has with a Duke team for infusions of children with unproven umbilical cord cells. This turns out to be a $58 million deal. It relates in a major way to a Duke compassionate use or expanded access program (EAP) that already had raised …

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Translating the FDA’s Q&A on end of stem cell grace period

The Rosetta Stone, The FDA

The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers …

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FDA alleges Cell Surgical Network links to US Stem Cell & COVID plan

Sean Berman Cell Surgical Network, ACT

The FDA has sought injunctions in federal court against two stem cell clinic firms including the clinic chain Cell Surgical Network headquartered here in California and US Stem Cell in Florida. According to new documents filed by the government in federal court here in California there may be more ties between the clinic firms than …

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Recommended reads: Bik, FDA letter, gecko cancer model, David Baltimore on COVID origin

gecko cancer

What can a gecko possibly teach us about skin cancer? Read on. It’s fun when a week’s worth of science reading covers so much territory including COVID-19, geckos that get cancer, a research misconduct sleuth, an FDA letter, and more. Baltimore weighs in on COVID lab origin idea Caltech has a very interesting interview with …

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New data on stem cell clinics, INDs, & more including from FDA itself

arm slide fda trip program

The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a …

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