July 13, 2020

The Niche

Knoepfler lab stem cell blog

FDA stem cells

5 min read

It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other key points, some of which are newer and worth digging into on a deeper level. What’s new here from the FDA? The piece by CBER Director Dr. Peter Marks …Read More

5 min read

In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgment against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a permanent injunction. You can read the new ruling here. The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of …Read More

3 min read

Laurie McGinley and William Wan of the Washington Post broke the story this morning that Google has a new biomedical ad policy that may really shake things up for stem cell clinics. Google announced the new policy on its blog that will restrict advertisements for unproven stem cell clinics, cellular and gene therapies. This is great news. Google Ads for stem cell clinics have definitely driven hundreds if not thousands of customers to unproven stem cell clinics. It’s very likely that many of the …Read More

4 min read

It can be kind of a big deal when politicians, especially at the federal level, write the FDA about stem cells. Is this going to be good news or bad? Some combination? I tend to worry that some senators or representatives might pressure the FDA to weaken oversight. However, lately it seems like the opposite is happening. Perhaps pressure the other direction, for less oversight, doesn’t see the light of day. Last April Senator Grassley wrote the FDA about problematic stem cell clinics and …Read More