Search Results for: perinatal fda

Q&A with Kyle Cetrulo of The Perinatal Stem Cell Society on the FDA, state laws, & more

Kyle Cetrulo, Perinatal Stem Cell Society

I was interested to see that an organization called The Perinatal Stem Cell Society seems to have been upbeat about the new Utah stem cell law. That law sets up a likely conflict with the FDA and federal law over stem cells. In a nutshell, Utah now says you can sell non-FDA-approved stem cells in […]

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FDA warns Neil Riordan U.S. perinatal firm Signature Biologics

Signature Biologics, Neil Riordan

Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama  clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the

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FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity

Dr. Leonid Macheret, FDA warning

Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this

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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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FDA warns another perinatal stem cell supplier Stemell

Stemell-logo

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain

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Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry

Liveyon

The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that  in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow

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Weekly reads: Altos Labs aging supplements pub, destructive NIH cuts, FDA warning, HSCs

Steve Horvath, Altos Labs

When I think of so-called aging supplements, visions of snake oil dance in my head. Possible benefits of supplements more generally have mostly not held up to long-term research. Supplements have risks too and so do purported longevity supplements. These pills claiming to fight aging are more in the realm of stem cell supplements that

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FDA letters to Chara Biologics & Evolutionary Biologics continue its unprecedented slew of warnings

Dr. Joy Kong, Chara Biologics, Chara Health

What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months. I wrote late last year how 2024

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Weekly reads: NIH freeze even before RFK confirmation, FDA warnings, RP stem cell trial data

NIH freeze

RFK isn’t even confirmed as HHS Secretary and things are going south already with an NIH freeze. What do I mean? NIH freeze could do lasting damage to biomedical research The Trump Administration has frozen many NIH processes including meetings such as study sections that evaluate grant proposals. No study sections means almost no new

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FDA warns Frontier Biologics as part of its more active trend

Chad W. Justice, Frontier Biologics

The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With

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