September 20, 2020

The Niche

Knoepfler lab stem cell blog

FDA

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

The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people have been hurt in Nebraska by some product involving exosomes. There is legit, exciting exosome research ongoing all over now. I believe these little cellular bubbles full of different …Read More

5 min read

In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgment against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a permanent injunction. You can read the new ruling here. The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of …Read More

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