September 30, 2020

The Niche

Knoepfler lab stem cell blog

Celltex

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

4 min read

Why is former Texas Governor/Trump Energy Secretary Rick Perry plugging unproven stem cells from a clinic firm called Celltex for COVID-19 prevention on Fox News? Perry follows in Giuliani’s footsteps? And more generally, what is it with conservative politicians promoting unproven therapies for COVID-19 and in particular stem cells for the novel coronavirus disease? First, we had Rudy Giuliani plugging what he called “stem cells” for COVID-19 on his webcast. This actually turned out to be natural killer (NK) cells, which are not stem …Read More

4 min read

When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow. Unfortunately, there are reasons to be increasingly concerned here. For instance, the idea that stem cells or exosomes could successfully treat COVID-19 is getting more buzz by clinics and other related firms. Sometimes it is getting hyped too in the …Read More

3 min read

Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by stem cell clinics using unproven fat stem cell injections, which are now clearly defined by the FDA as unapproved drug products being marketed unlawfully by clinics? First, let’s ask …Read More