September 29, 2020

The Niche

Knoepfler lab stem cell blog

Regenerative Medicine Advanced Therapy (RMAT) Designation.

3 min read

New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in store. How might that unfold? In one of his first statements that includes stem cells and regenerative medicine as Commissioner, Gottlieb perhaps gave us some hints within a new …Read More

3 min read

Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some REGROW-related provisions, but more moderate ones? The status quo of how the FDA regulated stem cell-based regenerative medicine therapies wasn’t working so great in past years so some reforms …Read More