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 »
People often ask me what is the most promising new cell therapy and while it is difficult to choose just one, I often highlight the promise of stem cells for diabetes. Here in the U.S., early data from diabetes clinical trials by Vertex look encouraging. Other teams worldwide are also working in this space and
It’s always fun to see startups with cool ideas in the regenerative medicine space and a new one called GC Therapeutics got some nice coverage this week. What do you think the name of this firm stands for? I have one main idea I mention below. Before we jump into it, I want to introduce
What do you get when you mix Doritos and mice? Apparently see-through mice. Of course, it’s not that simple but the finding related to Doritos has captured people’s attention. Doritos and mice I’ve had several people ask me about the Doritos orange dye and “transparent mice” paper. It is interesting that the orange dye in
Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely. They are not scientifically or medically proven to work or be safe so they could lead to substantial harm. This is yet another early step in a likely growing trend of states challenging FDA authority
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 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 »