umbilical cord stem cells

FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

FDA-draft-guidance

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …

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Feds want $3M, prison for Liveyon founder in old fraud case

John-Kosolcharoen-Liveyon-Bad-Batch

Before starting the umbilical cord cell supplier and marketing firm Liveyon, John Kosolcharoen was involved in some alleged health care fraud. The feds brought a case against him related to prescription drugs. Older case coming to a head As Liveyon was having its misadventures in the stem cell clinic sphere, the status of that past …

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Small umbilical cord stem cell COVID-19 trial: sign of efficacy?

Cord-blood-autism

A new paper today in Stem Cells Translational Medicine on a small COVID-19 Phase 1/2a trial using an umbilical cord stem cell product reports a surprising degree of possible efficacy. What’s the scoop here and could there be some hype in the media about this new study such as one of the authors describing the …

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Where do stem cells come from? Expert answers

axolotol, where do stem cells come from?

We often talk about stem cells but there are some pretty basic, important questions that often go unanswered like ‘where do stem cells come from?’ The Niche It’s a more complicated and interesting question than you might think. Some of the answers point to novel ways in which stem cells may be used to treat …

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Why did clinic supplier Liveyon halt sales while others have kept going despite FDA actions? Some insights including from John K

Liveyon-reincarnated

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in …

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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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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the …

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Sales of ‘zombie’, birth-related ‘stem cells’ continue to mushroom

zombie-stem

The birth-related stem cell clinic industry is a serious problem for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections. One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was predicted by the …

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FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely

Dr.-Scott-Gottlieb

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a …

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