Every year I make stem cell and regenerative medicine predictions. Looking at my predictions for 2023, they reflect a wild year but in many ways a good one overall. Below I have graded my 2023 predictions. Overall, my crystal ball gave solid results. Some of the predictions have been condensed to keep things concise, but you […]
2023 stem cell predictions grades reflect wild year for regenerative medicine Read More »
What is a woolly dog? Is it somehow related to the Woolly Mammoth? Before we get into that and the rest of my recommended reads, note that I’m finalizing my list of contenders for this year’s The Screamers Science Hype Awards. Last year The BBC won The Screamers for an article “Baby’s life ‘probably saved’
Holiday reads: woolly dog vs. mammoth, man eggs, designer B-cells, bluebird bio blues Read More »
The FDA has a unique mechanism called RMAT or regenerative medicine advanced therapy designation. It’s intended to move investigational regenerative therapies forward more effectively. RMAT data I recently updated The Niche RMAT list and it has jumped to 85. The FDA has approved many new RMATs this year. The data on how many applications the FDA
It’s kind of a tragedy that William P. Murphy, former chairman of unproven stem cell clinic firm, US Stem Cell, might be most remembered after his recent passing for his doings there. For example, I didn’t know until now of his prolific past as a biomedical inventor who did a lot of good. Instead, my impression of
Another kind of stem cell tragedy: William P. Murphy passes at 100 Read More »
The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for
For about as long as I’ve been writing The Niche, people have been asking about stem cells for MS. There’s a huge need for new therapies. While a chemo-based approach with autologous hematopoietic stem cell transplantation (HSCT) looks to work for certain cases of multiple sclerosis (although not yet approved in the US), other cell
Weekly reads: stem cells for MS, good news x2, extending dog years, Neuralink updates Read More »
The FDA issued a statement this week that there have been reports of new cases of blood cancer after patients received CAR-T therapies. The FDA specifically mentions T cell malignancies. New cancers in rare cases? In the announcement, FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell
Some CAR-T may very rarely cause new cancers Read More »
Cell therapy companies face many hurdles. I wrote recently about four cell therapy biotechs that have been really struggling. Blogging here at The Niche for more than a dozen years, I’ve seen many companies even go under. That’s bad news for the field, for patients, and for investors. Today I wanted to highlight some cell therapy
3 cell therapy companies doing well: Vertex, Vericel, & Regeneron Read More »
Paolo Macchiarini is one of a small group of people in the stem cell universe whose misconduct has blown up in the press. Piero Anversa, Haruko Obokata, Hwang Woo-Suk, and some operators in the unproven stem cell clinic sphere come to mind. Macchiarini published quite a few seriously problematic papers, some of which just hung
Weekly reads: late Macchiarini retractions, stem cells & Lululemon Read More »
There’s been much discussion about issues related to stem cells in the reproductive space such as human embryo models and differentiating stem cells into gametes, but there’s also interest in stem cell-assisted IVF. In this kind of method, stem cells are employed to make tissue cells such as ovarian stromal cells to support production of
Weekly reads: stem cell-assisted IVF, Takeda MSC trial, reporters getting stem cells Read More »