January 17, 2021

The Niche

Trusted stem cell blog & resources

Weekly pubs & 2 stem cell clinics get bad news

Even in COVID times the FDA continues its stepped-up efforts against stem cell clinics and patients are suing clinics more too, which I cover in today’s post along with recommended stem cell research pubs. One of the papers at the top of my to-read list is on 3D chromatin in stem cells.

markiewicz potoczny nature 2020 trf2 es cells
Data from pub on Trf2 surprisingly being somewhat dispensable for telomere protection in mESCs. Fig. 1d. Representative immunofluorescence and fluorescence in situ hybridization (IF–FISH) for γH2AX (red) and telomeres (green) in Trf2f/f ES cells and FLICs treated as indicated. Scale bar, 4 μm. Markiewicz-Potoczny et al., Nature 2020.

FDA Warning Letter to Vibrant Health Care stem cell clinic on COVID-19

From the FDA letter to Edgar Suter, MD:

“The FDA has observed that you offer an umbilical cord derived cellular product in the United States to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people.”

The letter notes claims by Suter about somehow “fortifying” the lungs against COVID-19, which in my opinion is likely an unsupported claim. Where are the data?

We’ve seen the FDA especially active against iffy stem cell and exosome claims for COVID-19 in 2020. In this case, the CBER branch of the FDA, which has a COVID-19 task force, required that Vibrant Health Care respond within 48 hours, an unusually quick turnaround time. You can check out our full COVID resource page, mainly focused on cellular medicine developments but also other areas as well, here.

Stemgenex clinic loses bid to throw out class-action suit

La Jolla, CA-based Stemgenex is a stem cell clinic firm that has been sued related to their online marketing. The suit was given class status and that status was reaffirmed in a new court decision.

The ruling reportedly does narrow the class to those who actually saw the questionable claims about patient satisfaction on the Stemgenex website, but the good news is that the case will continue as a class action suit.

Readers here on The Niche may remember many years of posts about the firm and my concerns about their claims. Some former Stemgenex staff have also appeared to be trying their hand at starting up new stem cell-clinic type firms as well.

To-Read List of Pubs

Circling back to the iffy corner of the stem cell world, I wonder how many stem cell clinics are operating during the pandemic. A few months back I called some and found quite a few trying to maintain their profit streams.

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