The FDA warning letter that Celltex received in late September (but that just went public yesterday–see my initial reaction here) is a possible game-changer for that company in my opinion. Why? The letter outlined in great detail the FDA’s concerns with how Celltex manufactures its stem cell product ranging from lack of documentation to concerns about aseptic/sterile technique issues to failure to control temperature. The FDA list goes on and on…and on….and almost every item starts with the word “Failure”. However, in addition, the FDA unambiguously …Read More
Sugarland, Texas stem cell clinic, Celltex, is most well known for having done the stem cell treatment on Texas Governor Rick Perry. What’s up with Celltex this week? There has a lot of talk behind the scenes that something big has happened. Very recently Celltex put out a PR recently saying it had received a “letter” from the FDA. What exactly was this letter? An untitled letter or a more serious “warning letter” as I speculated on October 1? It was indeed a warning letter. …Read More
I’ve been working with volunteer translators to make available a white paper on stem cells to as many people across the globe as possible. I call the project, Stem Cell Outreach Program for Education (SCOPE). SCOPE has been a big success and we are now at 21 languages! I want to again say my thanks to the amazing team of translators who have made this possible. SCOPE has opened the door to learning about stem cells to many more people around the world. It …Read More
The Japanese government reportedly (also here) is now investigating Moriguchi and also government funded research projects linked to him. These projects were funded in the millions of U.S. dollars. Meanwhile, the major Japanese newspapers are pointing out how the others (and to be fair, sometimes how they themselves) ran articles on Moriguchi over the years sometimes describing him inaccurately as from Harvard.