Search Results for: warning letter

Jellyfish on the brain: a critical look at Prevagen

crystal jellyfish aequorea victoria, Prevagen

I’ve been asked many times over the years if stem cell injections at for-profit clinics can help brain function, but recently the more common query is whether brain supplements such as Prevagen actually work. I’m skeptical of both unproven stem cell injections and supplements that are supposed to somehow help the brain, but some of

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Stem cell reads: liver buds, MSCs, SMARC, more

Liver-buds-from-stem-cells

It’s fitting, given the edginess over the election, that Halloween is falling only a few days before election day so here is a list of recommended stem cell reads for you to dive into some biomedical science. Liver buds from stem cells Generation of human induced pluripotent stem cell-derived liver buds with chemically defined and

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Q&A with Roxland on stem cell clinic suits by Iowa & Nebraska

beth-roxland

I wrote last week about the Nebraska and Iowa state Attorney Generals filing lawsuits against stem cell clinic firms and three individuals also named as defendants. Although I went into detail about the individuals including leader Travis Autor and the firms, I didn’t yet go into much depth on the state lawsuits themselves in that

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Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT

EUCYT-CEO-Travis-Bird

The FDA dropped a lengthy, extremely critical warning letter on a supplier of unproven exosome product called EUCYT Laboratories. For broader context, exosome therapy has somehow burst onto the scene when there’s no good data yet in my view to back up its use in the clinic. The FDA is taking notice with letters already sent

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COVID-19 cellular medicine buzz: Mesoblast, FTC hammer, more

cell therapy for COVID

  It’s been a busy week for the cellular and regenerative medicine space for COVID-19 news with some possible ups including for Mesoblast and some definite downs. Starting with the more positive media buzz with have Mesoblast. Mesoblast made COVID19 news “Thinly traded Mesoblast Limited (NASDAQ:MESO) rockets 51% premarket on average volume in reaction to its announcement of an

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As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes?

Kimera-Labs-exosomes-COVID-19-novel-coronavirus-disease

When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow. Unfortunately, there are reasons to be increasingly concerned here. For instance,

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FDA needs to act boldly on unproven exosome therapies

exosomes-visualized-by-EM

The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people

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