July 13, 2020

The Niche

Knoepfler lab stem cell blog

homologous use

6 min read

FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some surprises. The title of the article is “Balancing Safety and Innovation for Cell-Based Regenerative Medicine,” which really gets to the heart of what I think the FDA is trying …Read More

6 min read

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in draft form. There will be a 90-day comment period for the latter. Are today’s developments a good thing overall? I’d say “yes”, although there are still some ambiguities and …Read More

3 min read

Some stem cell clinics sometimes use questionable ideas to bypass FDA regulations and I’d go far as to say some of these are outright stem cell myths. One such argument that seems like a myth in my opinion relates to the idea of “homologous use”, which is one of the hottest issues in stem cells in the clinical arena right now. So what is homologous use and what is the clinic myth? The idea with homologous use goes that a stem cell product fitting that definition is similar to …Read More

2 min read

Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to reach out to the FDA to clarify the process. PK: When the FDA issues draft guidances is it a standard approach to have a public meeting of the kind …Read More