One of the most contentious areas in the regenerative medicine arena is whether a fat tissue product called stromal vascular fraction or SVF is a drug. The FDA says SVF, even in autologous form, is a drug. It is seeking an injunction against a California-based network of SVF clinics but lost the initial case. That […]
Recommend reads: FDA SVF warning, big Aspen grant, CSI finale invokes stem cells Read More »
I was interested to see that an organization called The Perinatal Stem Cell Society seems to have been upbeat about the new Utah stem cell law. That law sets up a likely conflict with the FDA and federal law over stem cells. In a nutshell, Utah now says you can sell non-FDA-approved stem cells in
Q&A with Kyle Cetrulo of The Perinatal Stem Cell Society on the FDA, state laws, & more Read More »
It takes a lot to surprise me these days in the cell therapy and regenerative medicine space, but some news from Walgreens stopped me in my tracks yesterday. The firm most well known for its drug stores and pharmacies has been struggling recently. Perhaps as a way to try to turn things around, they recently
New Walgreens shopping list: q-tips, aspirin, & cutting-edge gene & cell therapies Read More »
Looking for some stem cell good news? You’ll like today’s post. One mission of this blog The Niche is to promote rigorous science-based regenerative medicine, which can lead to investigating and writing about not-so-upbeat stuff. Risky clinics. People getting hurt. Patient lawsuits. Serious FDA, FTC, or state AG regulatory developments. Such actions can be good
Recent stem cell & regenerative medicine good news Read More »
If you remember Monty Python, then you probably recall John Cleese. We’ll start with Cleese’s stem cell baloney. Not spam. Secret to eternal youth? John Cleese extols virtues of stem cell treatment, The Guardian. I’ve written before about John Cleese’s stem cell anti-aging efforts. As I told the author of The Guardian piece, I love
I wrote a few weeks ago about a firm called RGCC or Research Genetic Cancer Center, which sells what I see as an unproven RNA therapy to clinics throughout the US. The approach is called supportive oligonucleotide therapy or SOT. After buying it from RGCC, the clinics then sell SOT injections for Lyme disease, other
US clinics selling unproven RGCC cell therapies in addition to SOT Read More »
A few dozen clinics in the US sell an unproven RNA therapy called supportive oligonucleotide therapy or SOT. The product comes from a Greek firm RGCC or Research Genetic Cancer Center, which also pre-tests patients’ gene expression to design the RNA product. Clinics marketing SOT in the US say it is intended to act by
Anti-aging might already be the big regenerative medicine story of 2024 and it’s only early March. Anti-aging hype going to the dogs? One of my 20 stem cell and regenerative medicine predictions for 2024 was that longevity would continue to make big news including in some not-so-great ways. In just over two months there has
Utah appears ready to pass a new stem cell law that would explicitly allow clinical use of non-FDA-approved placental cell drug therapies in the state. Bill 199 seems likely to set up a conflict with the FDA that may land in court. The key part of the bill says: “A health care provider whose scope
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 »