July 10, 2020

The Niche

Knoepfler lab stem cell blog

umbilical cord stem cells

6 min read

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 in academic research with sometimes biting science humor. I’ve also gotten many great questions on my Reddit AMAs both about stem cells and CRISPR. I’m focusing today on a …Read More

3 min read

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 been hurt. It’s important to know that reality and to hear directly from the real people who’ve been hurt. The podcast focuses in large part on a supplier called …Read More

3 min read

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 prior to injections of it into patients at clinics. There was the recall.  A dozen or more patients ended up in the hospital. Patients lawsuits stemming from that are …Read More

2 min read

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 warning letter is the clarity it brings that, yes, allogeneic umbilical cord stem cell and other perinatal stem cell products generally are drugs requiring a cleared IND and a …Read More