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.
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 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
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
- The Transition from Quiescent to Activated States in Human Hematopoietic Stem Cells Is Governed by Dynamic 3D Genome Reorganization, Cell Stem Cell. CTCF, chromatin organization, and LT vs. ST hematopoietic stem cell states. It’s important to think more of DNA in its physiological 3D state rather than just as 2D linear models.
- BMP signaling: at the gate between activated melanocyte stem cells and differentiation, G&D. From the Fuchs lab. The pathways here are likely to play some roles in human melanoma.
- TRF2-mediated telomere protection is dispensable in pluripotent stem cells, Nature. Surprisingly, they report that telomeres in mouse ES cells are not dependent on Trf2/Terf2, but seem to have alternative mechanisms at work. I wonder about how analogous experiments in human ES cells would turn out? See one of the beautiful images from the paper in a screenshot of Fig. 1d above
- M. tuberculosis Reprograms Hematopoietic Stem Cells to Limit Myelopoiesis and Impair Trained Immunity, Cell. Many viruses and some cancers can strongly suppress the immune system and alter its function in striking ways. I wonder how many other bacteria might be able to do this particularly pathogenic “trick” of suppressing aspects of hematopoiesis to throw a monkey wrench into immunity.
- A stem cell reporter based platform to identify and target drug resistant stem cells in myeloid leukemia, Nature Communications. Disease modeling and drug screening is a growing and big area of stem cell impact may not so anticipated decades back
- Warburg-like Metabolic Reprogramming in Aging Intestinal Stem Cells Contributes to Tissue Hyperplasia, Cell Reports.
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.