#celltex

Politics & FDA clearance of 2 stem cell clinic COVID-19 efforts

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…

Rick Perry plugs Celltex MSCs on Fox for COVID-19 prevention

Rick Perry plugging unproven Celltex stem cells for COVID-19 on Fox News.

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…

Kimera Labs photo on their webpage about idea of exosomes for COVID-19.

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…

FDA needs to quickly act against IRBs enabling risky fat stem cell clinics

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.

Alphabet soup of stem cell acronyms; IRB needs to be added to future version of photo!

Why would specific IRBs approve…

Is clinic firm US Stem Cell sued by FDA prepping for fat-free future?

Is fat-free always a good thing…even for unproven stem cell clinics?

It must be a challenge for a stem cell clinic firm like US Stem Cell, Inc. (USRM) to face an imminent possible future where it cannot sell injections of its main product, fat stem cells, in the US.

After all, “US” and “Stem Cell” constitute its name. Ouch.

It’s probable that a year or so from now the FDA lawsuitagainst USRM will…

Placebo effect & “the fade” after stem cell clinic shots

Sometimes when I talked about possible placebo effects with fans of stem cell clinics I feel like placebo becomes akin to a bad word in the discussion. However, any kind of medical procedure can cause placebo effects in people. We’re all susceptible to it.

Placebo effect, expectations from hype, public domain image

I believe that many perceived positive outcomes at stem cell clinics are really…

Top 10 questions on FDA suits targeting stem cell clinics

The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally going to be a drug product requiring premarket…