The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for …
Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the …
FDA warns Neil Riordan U.S. perinatal firm Signature Biologics Read More »
The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The …
Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »
Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this …
FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity Read More »
Cells including stem cells are grown in liquid solutions called media and stem cell culture medium composition is crucial since the ingredients have a powerful impact on the cells. The media affects the cells’ identities and functions. It also impacts the risks of using specific regenerative products. My first job in science was isolating and …
Why stem cell culture medium composition is such a big deal Read More »
What could go wrong with celebrities desperately hunting for stem cells as a fountain of youth? A flaskful of problems. Some famous folks can’t seem to get enough of stem cells, even if those supposed therapies are unproven and risky. In recent years, dozens of celebs have gotten stem cell procedures of various kinds. The …
Desperately seeking stem cells: celeb quests for elixirs often mislead Read More »
Dr. Paolo Macchiarini exemplifies how things can change quickly in the stem cell world and go from sky highs to deep lows. Stem cell rollercoasters Over the years, a few academic stem cell researchers as well as some operators in the unproven clinic sphere have had dizzying ups and downs. There’s John Kosolcharoen. His company …
Paolo Macchiarini guilty in criminal stem cell case but does a Houdini again Read More »
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
The site Top Class Actions reports that StemGenex, a former stem cell clinic in LaJolla, CA will have to pay out big in a settlement for a class-action lawsuit alleging fraud. Who gets what in StemGenex lawsuit settlement? In the piece, StemGenex, Lead Doctor to Pay $3.65M for Fraudulent Stem Cell Therapy Scheme, we learn that …
Clinic StemGenex & doc face $3.6 million class action settlement Read More »
When I read about Elizabeth Holmes and her blood testing startup Theranos I see parallels to hucksters in the arena of stem cells and cell therapy. I’m thinking especially of the unproven stem cell clinics out there. It goes farther than that though too, including people who aren’t hucksters at all but get caught up …
Elizabeth Holmes, Theranos, & lessons for the stem cell field Read More »