October 29, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: fda

4 min read

In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about previous such COVID-19 cell therapy clearances for the unproven clinic firms Celltex and GioStar here. The Stemedica trial is similar to some of the other cell therapy efforts for …Read More

3 min read

When you sit down to read science on the weekends lately, assuming you are not primarily a COVID-19 researcher, how much COVID stuff seeps into your reading? As I was going over some of this year’s recommended weekly reads posts here on The Niche, I’ve realized that an increasing amount of COVID-19 research has joined the list. Part of this is because of the explosion of cell therapy work and news on COVID, but also I’m just interested in the science of COVID. Before …Read More

4 min read

What’s been going on in the stem cell and regenerative medicine field over the past week and what are some worthwhile things to read? Today’s post has recommended recent reads from the scientific literature and the media. I’ve also got our weekly stem cell/regenerative medicine quiz question and the answer to last week’s. You can check out last week’s recommended reads here, which has last week’s quiz question. Toward the bottom of the post there’s also a “blast from the past” link to a piece …Read More

6 min read

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of cell therapy trials for COVID-19 mostly without much data, but the clearance of a few programs by for-profit stem cell clinics is especially problematic in my view. FDA on …Read More