Remember the Lung Institute? Many patients raised red flags about their experiences there. It was also once known as the Lung Health Institute. More generally, patients who have been harmed by stem cell clinics have had to rely on other ways beyond the FDA to try to do something about it. The FDA has been […]
Lung Institute stem cell clinic loses class action suit, patients awarded $9M Read More »
FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I
Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »
The idea of mesenchymal cells or MSCs for MS has been around for a long time. However, there haven’t been that many strong clinical trials testing it. There’s a new paper out that reports one of the stronger MSC-related trials for MS in terms of design. In this case, they didn’t use just MSCs but
Mostly discouraging trial of MSC-NPs or purported neural cells from MSCs for MS Read More »
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 »
Can researchers use CAR-T for lupus? It’s always exciting when one’s home institution has an interesting new therapy in development. Here at UC Davis Health, there has been an increasing stream of such encouraging trials in the pipeline. I’ve written before about the promising trial of stem cells for spina bifida. Now there’s news related
Recommended reads: CAR-T for Lupus, CRISPR vision, journal closures 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 »