June 1, 2020

The Niche

Knoepfler lab stem cell blog

Florida stem cells

3 min read

A variety of states have stepped up to address unproven stem cell clinics within their borders and the latest is Vermont. According to the VTDigger and writer Anne Wallace Allen, the Vermont Medical Society is planning a number of steps to address this situation. For example, at their encouragement a Vermont lawmaker will introduce legislation to regulate stem cell clinics in the state: “Vermont lawmakers will be asked in the coming year to consider regulating stem cell clinics like Vitality Healthcare in Williston and …Read More

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

3 min read

There’s the batmobile for Batman, right, but what about a stem-cell-mobile? Every so often someone sends me some wild new stem cell clinic thing that they’ve seen that is both real and almost unbelievable at the same time. The latest is a mobile stem cell “clinic” business called RegenMed of Florida, which is what I’m calling the “stem-cell-mobile”. There isn’t much info on this company on the web including on their homepage, but I did find their Facebook page and a picture of what …Read More

5 min read

There’s a lot going on in Florida with non-FDA approved stem cell offerings even just related to stem cells for vision problems alone, but while US Stem Cell has drawn the most attention related to patient allegations of severe vision loss in Florida after fat stem cell injections in eyes, another group I’ll loosely call the “SCOTS Trial” has also been injecting investigational stem cells (in this case from bone marrow) into patients’ eyes and some patients have made allegations of harm there too in …Read More

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