September 27, 2020

The Niche

Knoepfler lab stem cell blog

Duncan Ross

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

A firm called Kimera labs just received an untitled letter from the FDA. The firm has been supplying non-FDA-approved exosomes to various customers including at least one stem cell clinic without sparking any obvious action from the agency, but on April 10th that changed with the letter, which in my view is quite serious. What sparked it? My sense is that a major trigger was Kimera Labs being linked some weeks back to an experimental infusion of exosomes into a COVID19 patient. The letter …Read More

7 min read

University of Minnesota bioethicist Leigh Turner has been threatened with a lawsuit by a stem cell clinic-related business. Lawsuit threats in this arena come up every so often and as much as they are unpleasant realities, they can also reveal some important aspects of the stem cell arena. Ars Technica reported yesterday that Leigh’s recent paper on stem cell clinics and businesses associated with them with listings of non-FDA approved offerings in Clinicaltrials.gov was the impetus for the threat of a lawsuit and intention of asking …Read More