umbilical cord stem cells

Patients stem cell Q&A#1: can clinic injections cause GVHD?

Colonic_graft-versus-host_disease-GVHD

People ask me questions about stem cells all the time so I decide to do a new blog series answering your questions. Today’s post is  the first in this new stem cell Q&A series. Past series have included my Elephant in the Lab series that provides some insights into the craziness that sometimes goes on …

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Bad Batch podcast’s dark picture of perinatal stem cell industry

John-Kosolcharoen-Liveyon-Bad-Batch

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have …

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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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Stem $ell$: clinic marketeers dangle big bucks to docs

stem-sells-marketing

Over the last couple of years the marketing of unproven clinic injections of non-FDA-approved stem cells seems in open-throttle mode. What used to just be on the web here and there is now on billboards, newspapers, flyers, infomercials, and on TV. It’s possible that millions of dollars are being spent yearly on advertising this stuff, …

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Weekend reads include herding brains, stem cells, & CRISPR

Stem-cells-the-niche-anti-aging

Every so often here on The Niche I list science and news articles worth a look as “weekend reads”. Below is my list for this weekend. Enjoy! The first article doesn’t really fit into the other main categories, but the title “herding brains” caught my eye. Stem Cells Stem cells and regenerative capacity in aging …

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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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Stem cell clinic supplier Liveyon tries to regenerate itself after FDA recall

Liveyon-reincarnated

You probably remember Liveyon. It’s a marketer of an “umbilical cord stem cell” product that was recently recalled by the FDA. The recall was due to adverse events that may have included E. coli contamination somewhere before it was injected into patients, some of whom apparently got sick. Since it seemed like this recalled product was …

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