Search Results for: warning letter

Liveyon product hurt many more patients says new CDC study

Liveyon

Liveyon is a cord blood product marketer that distributed a batch of cells a couple of years back that led to many patients being hospitalized with infections. Some had sepsis and ended up in the ICU. It was thought at the time that about a dozen patients who had been injected with the Liveyon product […]

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Weekly recommended reads including asymmetric division & chromatin

Asymmetric division and chromatin

One of my favorite types of papers are those on stem cells and chromatin, and a new one in Current Biology caught my eye this week. My own lab website has the URL chromatin.com so that says something. You can also read more about our research here. Recommended reads: chromatin and stem cells, more Asymmetric

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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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What is Wharton’s jelly & its possible clinical uses?

Wharton's jelly umbilical cord H&E

For more than a year in my first job as a scientist I isolated cells from umbilical cord veins and then tossed the tissue away, never realizing there was more there that could be useful in the form of something called Wharton’s jelly. What’s in this article Umbilical cord histology & Wharton’s jelly | What

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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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FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

stem cell clinics map

Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics

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Perspectives on BioLife: one name, distinct companies

boston biolife

In the stem cell world some corporate names end up being very similar with the latest example being several companies with the name “BioLife.” Get a BioLife…name I guess BioLife is a catchy term. You’ve got life and biology in there in one name. Let’s deconstruct what’s going on out there with this corporate name.

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21 Stem Cell Research & Regenerative Medicine 2021 Predictions

stem-cell-crystal-ball-300x3001

In any given field of biomedical science like stem cell research and regenerative medicine, it’s very useful if you can accurately predict the future. It seems, though, that predictions are far more difficult within the more exciting and rapidly-changing fields. The field of stem cells and regenerative medicine fits that bill. Past stem cell research

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