Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of […]
Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan Read More »
What happens if unproven stem cell clinic firms like GIOSTAR start getting okays from the FDA to do clinical trials? On the one hand, it could reflect a positive trend of stem cell clinic firms working with the FDA and toward compliance. Having more robust data. However, I worry about some of these types of
The cell therapy biotech Capricor recently released new data from their Duchenne Muscular Dystrophy (DMD) trial work. The data have generated excitement in the patient advocacy community. The stock has skyrocketed. How exciting are these new data? CEO Linda Marbán is quite upbeat and I think it’s justified. The firm is now seeking FDA approval
Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data Read More »
I’ve met people who are excited about using stem cells for Parkinson’s Disease. Some of these folks have Parkinson’s or are loved ones. Talking to them makes things real. It feel personal and not just scientific. The current treatment options are far away from what is needed for many people. I am optimistic that a
Weekly reads: Parkinson’s & the gut, sports, cat stem cells Read More »
How are things going with regenerative medicine and stem cells in Japan? It’s still an exciting time there, but I’ve noted a sense that it is a time of transition too in some ways. For example, government funding is perhaps less certain than in the past. Let’s start with a few articles on how the
Recommended reads: Stem cells in Japan, iPS cells for COVID & hearts, He Jiankui Read More »
Mesenchymal stromal/stem cells or MSCs are widely used by unproven clinics, but MSC research also suggests real promise in specific areas. Clinics mainly use adipose MSCs (often called SVF) or bone marrow MSCs. However, umbilical cord MSC preparations are getting more popular too. Many questions swirl around the use of MSCs including what exactly are
When I was first really getting into stem cells as a trainee the name Catherine Verfaillie came up as a scientist to watch in the adult stem cell area. It wasn’t too long after that though that I started hearing that some of the work from her lab at the University of Minnesota was being
Recommended reads: Nature Catherine Verfaillie retraction, Horvath paper, Vertex Read More »
Do many in the regenerative medicine field have favorite types of stem cells? Some seem to think there’s a tension between those working on pluripotent stem cells like iPS cells and those working with MSCs. I don’t see it that way, though. Whatever stem cells work best for a particular condition should be used and,
Weekly reads: diabetes, GvHD, Novo Nordisk & regenerative medicine, HDACs Read More »
A new paper on stem cells for paralysis from a Mayo Clinic team has sparked a bit of legitimate hope but also some hype in the media. The publication was in Nature Communications. It is entitled “Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial.” The approach was direct injection
Perspectives on new stem cells for paralysis paper & media coverage Read More »
The Mayo Clinic does some great research on stem cells and regenerative medicine. However, at times I’ve felt that a few Mayo researchers are overexuberant. This mainly relates to certain not-yet-proven stem cell and related offerings. Fitting with that perception, the Mayo website also has some inaccurate stem cell content that leans toward overstating things.
Key Mayo Clinic stem cell webpage is overexuberant & outdated Read More »