Today was day one of the Houston Stem Cell Summit, at which Guv Rick Perry was a keynote speaker. I thank the organizer for inviting me to attend and I wish I could have, but I’ve spent a good chunk of the day today teaching medical students right here in Sacramento, CA so I could […]
Rick Perry on Celltex: I disagree with the FDA Read More »
The Houston Chronicle has posted the response letter from Celltex to the FDA in regard to the FDA Warning Letter issued to Celltex. The Chronicle also has a piece up on the warning letter that is a great read here. My thoughts on the possible paths for Celltex moving forward can be found here. The
Celltex response to FDA says transplants stopped: what are the other key points? Read More »
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
Will stem cell clinic Celltex reinvent itself after game-changing FDA warning letter? 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
Did Celltex just get an FDA warning letter? I’m not sure. We may find out tomorrow as the FDA updates their public warning letter list early in the week. What’s Celltex? Celltex is that famous stem cell company in Sugarland, Texas that gave Guv Rick Perry stem cell transplants. It was inspected by the FDA
Did Celltex just get an FDA warning letter? Read More »
The Texas Tribune held a liveblog regarding Health & Human Services at festival they were sponsoring. A particularly testy, interesting exchange on stem cells occurred (see starting around 2:51PM) involving Andrea Ferrenz of Celltex and Dr. Leigh Turner of University of Minnesota as well as Texas State Rep. Rick Hardcastle and David Bales of Texans
Stem cell shootout at the Texas Trib Festival including Celltex Read More »
The Texas stem cell clinic, Celltex, is lately becoming a model of transparency in the biotech industry. They are willing to answer many (if not all) questions I’ve been asking them. Celltex is involved in stem cell isolation and multiplication, and banking (see post here on the pros and cons of stem cell banking) as
Interesting new insights into Celltex’s business model Read More »
I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below: Dear Dr. Knoepfler, Thank you for your interest
Celltex unsure if FDA agrees product isn’t a drug, but expects 2nd FDA visit soon Read More »
I’m enjoying Celltex’s new website and I’m appreciative of their great responsiveness to my questions. Transparency is a beautiful thing! My latest question to them was whether they, given that the FDA called them a “drug manufacturer”, are now planning to or have already filed an IND. An IND is an application for an investigational
More Celltex Q&A: we are not a drug manufacturer Read More »
How does Texas stem cell clinic Celltex make their stem cell drug? This is a very key question as the answers will help the stem cell field evaluate this drug’s potential safety and efficacy. I’m calling it a “drug” because the FDA called Celltex a “drug manufacturer” and by all past FDA precedent as well
My ongoing Q&A with Celltex on their stem cell drug production methods Read More »