July 10, 2020

The Niche

Knoepfler lab stem cell blog

FDA Warning Letter

5 min read

The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on lead-up to wave of FDA activity I count 7 letters in a less than two-month span from mid-March to now, which may be the most in history in the …Read More

3 min read

Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning letter went out to Invitrx mentioning almost as an aside an unapproved exosome product amongst many other products and issues. What’s the backstory with Invitrx? I wrote last year about …Read More

3 min read

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in supply. Why did Liveyon chose to halt sales at least for the moment? By comparison other clinic-related firms have continued business as usual despite various FDA actions against them …Read More

5 min read

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day for perinatal stem cell clinic and exosome suppliers. For general background on exosomes see these past The Niche posts. I’m sure there are a lot of hardworking folks at …Read More