January 16, 2021

The Niche

Trusted stem cell blog & resources

perinatal stem cells

4 min read

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest untitled letter went to RichSource Stem Cells, Inc. and its CEO Sara Oracle, a firm which markets an unusual “combo” product described this way by the FDA, “a combination …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

2 min read

I’m relatively new to podcasts, but am enjoying a new stem cell-focused one called Bad Batch by medical journalist Laura Beil, which I’ve been listening to in the car as I commute. I just finished episode three. I’m curious to hear how the next few episodes of the story unfold. I talked and emailed with Beil as she worked on this project. Her rigorous approach impressed me and she clearly did her homework on it. Bad Batch comes from podcast network Wondery. It is …Read More

4 min read

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain suppliers are strong driving forces behind more patients being put at risk. Also, each supplier may enable dozens of clinics so there’s some logic here to the FDA putting …Read More

5 min read

Up until now Utah hasn’t immediately come to mind as a hub for stem cell issues, but things are heating up there in 2019. Utah? I was going to do a blog post here on The Niche last month about perinatal (birth-related) biologics and stem cell-related supply companies in Utah. Some of their customers appear to be unproven stem cell clinics so that concerned me. I even started writing a draft post many weekends ago. However, it’s taken some time to try to square …Read More

4 min read

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a lot of subtext in the FDA letter and accompanying PR, in my view none of it good for the company or its “centers of excellence.” The R3 website also …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

There’s a lot of questionable “stem cell” injections these days involving purported amniotic stem cell or other perinatal (birth-related) material. Regulators are taking note including the FTC, which took some unprecedented action last year on this front. Now the FTC has announced that more than half a million $USD have been returned to consumers who got dubious “amniotic stem cell” material. From the FTC announcement: “According to the agency’s October 2018 complaint, Dr. Bryn Jarald Henderson, D.O. and the companies he owns and operates, …Read More