It’s been a long saga for the FDA and the unproven stem cell clinic group called Cell Surgical Network, headquartered in Beverly Hills. A court case involving the two has been unfolding for many years. It has big implications for agency authority and the hundreds of stem cell clinics across the U.S. The case took […]
What are the most significant stem cell and regenerative medicine good news stories of 2024? Since it has been an eventful year, there are many possibilities. Please see our poll at the bottom of this post and weigh in on what you think is the most important encouraging news. If you don’t see your choice
Poll on stem cell & regenerative medicine good news of 2024 Read More »
This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve
Big spike in FDA warning letters to unproven biologics firms Read More »
I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them
FDA wins big in key federal stem cell clinic court case Read More »
The FDA just warned a Florida stem cell clinic firm called Mother Stem Institute run by Dr. Alvaro Skupin. Background: Mother Stem Institute past issues I’ve written about this clinic and Dr. Skupin in the last few years. Just about a year ago I blogged the news that a patient suit against the clinic was
FDA warns Mother Stem Institute & Alvaro Skupin 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
I’ve only met one scientist who was openly a Trump fan, but I’m sure there are more out there. Still, it seems most scientists are no fans of the former president. A new WaPo piece highlights how federal scientists are worrying about a possible second term for the former president. Government scientists & a second
Recommended reads: gov scientists fear Trump 2nd term, MYCT1 in HSCs, in vivo editing 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 »
I was able to watch some of the 9th Circuit Court hearing today on the FDA appeal of its loss in the Cell Surgical Network lawsuit. This post is my brief impressions as a scientist. What went down? Do the three judges seem to be leaning one way or another? The ruling in this case
9th Circuit hearing on FDA appeal of Cell Surgical Network case: maybe encouraging? Read More »
There has been a steady stream of encouraging data on stem cells for MS. Particularly for certain kinds of MS. A new study adds to this upbeat direction. Good news on stem cells for MS Haematopoietic stem cell transplantation for treatment of relapsing-remitting multiple sclerosis in Sweden: an observational cohort study, Journal of Neurology, Neurosurgery,
Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit Read More »