June 2, 2020

The Niche

Knoepfler lab stem cell blog

Caroline Chen ProPublica

4 min read

Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. While the FDA didn’t send R3 Stem Cell a formal warning letter, in my view the agency made it very clear in the “untitled” letter that this firm should make some changes. The letter went out both to R3 Stem Cell and its dozens of …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

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