When I first saw the new FDA warning on stem cells for pets and the logo for the company that received it, I was surprised in a few ways. I don’t recall ever seeing such a letter and the logo is something else. We’ll get into all of that in a moment, but first, since […]
Recommended reads: FDA warning on stem cells for pets, chromatin, aging & HSCs Read More »
I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah
Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society Read More »
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’ve been wondering how the new Google AI overviews feature on its search platform would turn out for various stem cell searches. Frankly, I had a bad feeling that Google was going to blow this. Unfortunately, it seems even worse than I anticipated. Let’s go through three examples and talk about why this is so
Google AI overviews on stem cells are a bust so far & endanger public health 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 »
Stem cell hype is a big problem these days. It’s been going on for decades. Even some generally good citizens of the stem cell and regenerative medicine arena engage in it at times. Maybe a few of them don’t even realize what they are doing. I think a few journalists occasionally fall into the hype
Recommended reads: 3 infected in Mexico, stem cell hype, hearing restoration Read More »
We’ve known that most organs have resident stem cell populations for decades, but things have been less clear in the lung and it has only been relatively recently that lung stem cells have been definitively characterized. Why is so important? Lung stem cells, whether endogenous or made in the lab, have the potential to help
Recommended reads: lung stem cells, Utah stem cell law, Ozzy gets cells 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 »
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 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 »