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 »
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 »