The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? I’ve been hearing the name Liveyon pop up […]
FDA recalls Liveyon stem cell product: blow to big clinic supplier? Read More »
How is research looking on stem cells for diabetes? I’m feeling more encouraged about the clinical research in that area. Before we jump into that let’s talk about two other things. The big news of the week was the felony plea deal by Liveyon’s John Kosolcharoen to charges related to marketing an unapproved cell therapy
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 »
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 »