November 30, 2020

The Niche

Knoepfler lab stem cell blog

celularity

3 min read

What a difference one day can make including in the types of questions I’m getting with this one rising to the top: should President Donald Trump get stem cells for his COVID-19? Whether he should or not, will he get them? This is more than a hypothetical as a surprising number of people in Trump’s orbit have promoted the idea of unproven stem cells more generally or specifically for COVID-19. Roger Stone For instance, Trump pal Roger Stone at some point reportedly was or …Read More

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

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

3 min read

What are you reading these days and does it include topics like cell therapies for COVID-19, ALS, regenerative potential of fibroblasts, and why Zoom meetings are so tiring for the brain? I cover those topics and more below with recommended reads including papers and media items. Here’s last week’s recommended reads. Here’s to fibroblasts, which have regenerative activities Distinct Regulatory Programs Control the Latent Regenerative Potential of Dermal Fibroblasts during Wound Healing. This work from a team led by Jeff Biernaskie was published in Cell Stem …Read More