October 19, 2020

The Niche

Knoepfler lab stem cell blog

fat stem cells

4 min read

Is “snake oil” too harsh a term for some of what is sold at some of the worst stem cell clinics? Is the phrase “stem cell clinics” itself accurate and useful in a broad sense? When we read or write the phrase “stem cell clinics”, most people generally know what we’re talking about, but it is not a very precise use of language, especially these days with so many different clinics out there, and there is a lot of room for error. There are …Read More

5 min read

In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to deal with the highest risk stem cell clinics, but unfortunately the FDA sent mixed messages on clinics in a broader sense and in some ways left the door open …Read More

2 min read

Sacramento’s Nervana stem cell clinic has been selling non-FDA approved stem cell therapies to patients for a variety of conditions including arthritis, pain, and neuropathy for a while now since last year, but in my opinion there isn’t good evidence to back up using amniotic or fat stem cells for such conditions. Further, my understanding is that if living amniotic stem cells are being used in this way, they would constitute a biological drug requiring FDA pre-approval. Nervana’s advertising is part of a larger …Read More

3 min read

In the total the FDA has held 3 days of public meetings on stem cells in the last few weeks ranging from science to policy and hearing from many parties including patients and even stem cell clinics so the big question now is, “what happens next?” The FDA has 4 draft guidances pertaining to investigational stem cell clinical procedures and these were the subject of the second meeting that last a couple of days. Soon the FDA’s online commenting period related to these issues …Read More