Here are my recommended weekly reads for The Niche readership for early February 2021 including COVID-19 and stem cell lawsuit updates, papers, and more. How many papers do you end up reading each week or month these days? More or less than before the pandemic?
- New diabetes cases linked to covid-19, WaPo
- ICYMI from here on The Niche: Lawmaker indicted for selling fake stem cells for COVID & more
New Regenerative Medicine INDs; Korea rejects COVID one
IPSC-related IND. Factor Bioscience spins out a new cell therapy player with eyes on the clinic within 2 years, EndPoints
“The company will be unveiling a CD19-targeted CAR-T and CAR-NK, Fiore said, with ROR1 as its next target…The CEO says Exacis’ approach is what differentiates it from others in the crowded cell therapy field, beginning with mRNA technology in-licensed from Factor. The process starts with induced pluripotent stem cells (iPSC), which are blood or skin cells that have been engineered back into an embryonic-like stem cell state. They’re created with mRNA reprogramming, and then edited to avoid host immune surveillance, add a CAR and enhance the cells for potency against tumors.”
Vertex IND for Diabetes. Vertex Announces FDA Clearance of Investigational New Drug (IND) Application for VX-880, a Novel Cell Therapy for the Treatment of Type 1 Diabetes (T1D)
Organicell IND for COPD. Organicell Announces FDA Approval of IND Application for the Use of Zofin™ in the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A perinatal cellular medicine product.
Korea says no on COVID-19 cell therapy IND that FDA cleared. Korean regulators rejected an IND-like application from Nature Cell for a stem cell study in COVID-19 patients, citing too little data (HT, Leigh Turner). Notably, Nature Cell received an FDA IND clearance for a study of the same product. I believe the FDA has cleared way too many INDs of cellular medicines for COVID-19, including especially from stem cell clinic firms.
- H3.3-K27M drives neural stem cell-specific gliomagenesis in a human iPSC-derived model, Cancer Cell. This one is of special interest to my lab in our studies of mutant H3.3 in DIPG.
- Drosophila female germline stem cells undergo mitosis without nuclear breakdown, Current Biology. See screenshot of Fig. 1b above. What a striking difference in germline cells undergoing mitosis.
- Mesenchymal stem cell-derived interleukin-28 drives the selection of apoptosis resistant bone metastatic prostate cancer, Nature Communications
- Nature Genetics brings us, Metabolic control of DNA methylation in naive pluripotent cells
- The diversity and function of sourdough starter microbiomes, iLife
- Preclinical Efficacy and Safety of a Human Embryonic Stem Cell-Derived Midbrain Dopamine Progenitor Product, MSK-DA01, Cell Stem Cell
- Are your stem cell influenced by what you eat? Dietary interventions as regulators of stem cell behavior in homeostasis and disease, G&D, review. There’s been a great deal of attention given over the years to the idea that one’s diet may influence the numbers and/or functions of our stem cells. In another weekly recommended reads I highlighted a surprising paper linking spicy food and specifically capsaicin to stem cell function.
- Review: The evolving definition of salivary gland stem cells, npj Regenerative Medicine
Stem Cell Clinic Lawsuit Updates
- US Stem Cell, Florida Firm Under FDA Injunction, makes arguments in its appeal. Press Release: USRM Oral Argument in Appeal from FDA Enforcement Action. The stakes are very high here.
- For Cell Surgical Network the case is delayed likely until May. The Judge ruled about a year ago against the feds’ request for summary judgment, a small but important victory for the defendants. The COVID-19 pandemic has since delayed the trial. Readers of The Niche may recall that material from our site is included in the case by the DOJ.
- As best as I can tell, the proposed class action suit against the Lung Health Institute remains to be resolved, but likely has also been delayed by COVID. You can see a background post I did on this suit here. The newest media item I could find on the lawsuit is this from a local Tampa news channel last summer, which reports there could be up to 900 defendants.
- Several State AGs have suits pending against stem cell clinic firms, but I have not seen any major new developments with those cases recently.
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