July 10, 2020

The Niche

Knoepfler lab stem cell blog

minimal manipulation

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

The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally thought in the for-profit stem cell clinic field. “Industry” apparently hasn’t been happy about this. For instance, December 2014 FDA draft guidance very clearly indicated that fat-related stem cell products …Read More

1 min read

In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances  (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has requested that the FDA clarify the term “main function” for human cell and tissue products (HCT/Ps). ARM rightly points out that HCT/Ps can have more than one function. For example, adipose …Read More