In a ruling that could turn FDA stem cell clinic oversight on its head, Federal District Court Judge Jesus Bernal last night ruled in favor of the stem cell clinic chain Cell Surgical Network and other defendants. The FDA had been seeking permanent injunction against them. Here’s the court ruling. Drs. Mark Berman and Elliot […]
Judge drops a bomb on FDA in Cell Surgical Network stem cell clinic case Read More »
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 judgement 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
I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them
FDA wins big in key federal stem cell clinic court case Read More »
I was able to watch some of the 9th Circuit Court hearing today on the FDA appeal of its loss in the Cell Surgical Network lawsuit. This post is my brief impressions as a scientist. What went down? Do the three judges seem to be leaning one way or another? The ruling in this case
9th Circuit hearing on FDA appeal of Cell Surgical Network case: maybe encouraging? Read More »
Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024. You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please
20 stem cell & regenerative medicine predictions for 2024 Read More »
The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The
Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »
The FDA has finally filed an appeal of the Cell Surgical Network lawsuit verdict. It took them a very long time for some reason. The stem cell clinic chain Cell Surgical Network and other defendants had prevailed in a federal district court here in California in front of Judge Jesus Bernal. Their adipose cell product, stromal
FDA appeals Cell Surgical Network lawsuit verdict Read More »
The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics. I believe the ruling was founded in part on
Weekly reads: CRISPR, FDA stem cell loss, pioneering AMD study, MS, Verve Therapeutics Read More »
The past year was all over the place for the stem cell and regenerative medicine field. As you can see in my scoring of my 21 predictions for 2021, quite a few things were surprises in terms of what did and didn’t happen. Here’s an overview of the top stories of the year in our
Top stem cell stories of 2021: COVID, diabetes, human embryos, clinics in court Read More »
A stem cell clinic in the Cell Surgical Network chain has just been sued allegedly for causing vision loss in a patient. By my count, across the U.S. this makes at least 5 patients who have said they were either totally blinded or had some major vision loss after getting stem cells injected into their
New suit for vision loss against Cell Surgical Network clinic Read More »