January 17, 2021

The Niche

Trusted stem cell blog & resources

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

2 min read

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, which means far more than that huge amount is being taken in as revenue by clinics and their associated businesses such as marketing firms. But there’s a different and …Read More

2 min read

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 brain, article in Cell. Quiescence Modulates Stem Cell Maintenance and Regenerative Capacity in the Aging Brain. Does this kind of research have relevance to humans? See interesting, complex graphical abstract …Read More

4 min read

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 data that Leigh Turner and I published in one of our collaborative papers in which we saw an upward slope in the number of businesses selling amniotic or other …Read More

4 min read

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 likely crackdown A subset of these clinics are particularly risky and egregious in their behavior. While this subset constitutes may be “only” one or two hundred such clinics out …Read More

2 min read

E. coli is a type of bacteria that can cause diseases such as serious GI illness if it ends up in the wrong place like in your food. You can spend the night in the bathroom or end up in the hospital or more rarely a grave depending on the subtype of E. coli. Some are harmless or maybe beneficial. You can imagine that if pathogenic E. coli or similar bacteria are present in a drug product (which can include stem cells) that is …Read More

3 min read

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 a major part of Liveyon’s business model, some wondered: could the company survive the recall? My sense at the time was that it would just find another source for …Read More