July 13, 2020

The Niche

Knoepfler lab stem cell blog

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