August 5, 2020

The Niche

Knoepfler lab stem cell blog

stem cell law

2 min read

California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved. At this point, 4+ months into the enforcement period, I’m not sure if anyone has looked into compliance. Anyone know? If you run a stem cell clinic, have you posted notices? Is you are a patient in California who has been to such a …Read More

7 min read

At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it play out? For some discussion and potential answers, I turned again to Professor Patricia Zettler of George State University School of Law, an expert on stem cell oversight, the …Read More

2 min read

There’s some also encouraging action at the state level on direct-to-consumer stem cell clinics operating without FDA approval including most recently in Washington State. Last year here in California we passed a bill into law that (1) requires stem cell clinics selling non-FDA approved therapies to post notices for patients and (2) instructs the state medical board to keep track of the situation. Democratic Senator and Dr. Ed Hernandez was the sponsor. More recently Republican lawmakers in the Florida State legislature sponsored a bill aiming …Read More

2 min read

Florida is a hot mess on the for-profit stem cell clinic front. My own state of California isn’t much better and actually has a great number of clinics, but more problems are coming to light in Florida, at least at this point. Now WLRN reports that a legislator in Florida has proposed a new bill to try to address some of the issues with the clinics. Many clinics in Florida are making money from vulnerable patients and in some cases have apparently caused them harm, including claimed …Read More