October 24, 2020

The Niche

Knoepfler lab stem cell blog

FDA

4 min read

A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process. What’s going on? A number of states have been stepping up action related to stem cells and specifically stem cell clinics. The steps on unproven clinics range from bills, some of which have become law such as here in California and …Read More

4 min read

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a likely crackdown A subset of these clinics are particularly risky and egregious in their behavior. While this subset constitutes may be “only” one or two hundred such clinics out …Read More

3 min read

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class …Read More

4 min read

The stem cell clinic industry selling unapproved “therapies” is ubiquitous and yet somehow still growing it seems. Many of us are encountering more of them including via ads and the clinics are basically all over the place. What should someone do if they see a stem cell clinic that is particularly concerning? A lot of people are asking me this question lately. There are a variety of options depending on your level of concern, but below is a guide to possible actions you can …Read More