January 26, 2021

The Niche

Trusted stem cell blog & resources

Celltex

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

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

2 min read

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 lawsuit against USRM will be over and the “fat stem cell lady” will have sung …Read More

3 min read

Sometimes when I talk 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. I believe that many perceived positive outcomes at stem cell clinics are really placebo effects. Why? For one thing, many patients have told me about a phenomenon I’ll call “the fade”. Stem cell clinics themselves know exactly what I mean …Read More

3 min read

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 approval. You can see my first quick take on these federal suits here as well as initial responses to the suits …Read More

4 min read

The recent news that Texas A&M University has inked a full-blown deal with the direct-to-consumer stem cell clinic firm Celltex struck me as an unusual development. Recently we’ve seen more universities exploring the use of stem cells outside of the traditional FDA clinical trial process that is fundamentally based on an investigational new drug application (IND). Some institutions apparently have even potentially started teaming up with clinics for patient treatments muddying the waters out there. However, in the case of Celltex and Texas A&M my guess …Read More