September 24, 2020

The Niche

Knoepfler lab stem cell blog

Florida stem cells

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

2 min read

If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a clearly non-compliant fashion? FDA Commissioner Scott Gottlieb has used very strong language to describe stem cell clinics including the phrase “bad actors”, but so far we haven’t seen much …Read More

2 min read

The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the alleged blinding of some of its customers in 2016, faced two lawsuits (now settled) on that front, and now has to deal with a third lawsuit. Second, probably in part …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