Celltex

FDA OK’s more COVID-19 efforts of unproven stem cell clinics

The-FDAs-big-COVID-stem-cell-clinic-can-of-worms-small

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 …

FDA OK’s more COVID-19 efforts of unproven stem cell clinics Read More »

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

Anand-Srivastava

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 …

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

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

Rick-Perry-plugging-Celltex-stem-cells-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 stem cells for the novel coronavirus disease? First, …

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

As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes?

Kimera-Labs-exosomes-COVID-19-novel-coronavirus-disease

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, …

As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes? Read More »

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

alphabet-soup-819x1024-239x3001

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 …

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

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

fat-free

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” …

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

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

placebo-effect-expectations-from-hype, science hype

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 …

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

10 questions on FDA suits targeting stem cell clinics

SVF2

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 …

10 questions on FDA suits targeting stem cell clinics Read More »

Why did Texas A&M ink big deal with stem cell clinic firm Celltex on exosomes?

Texas-AM-Celltex-deal

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 …

Why did Texas A&M ink big deal with stem cell clinic firm Celltex on exosomes? Read More »