What does the future hold for the privately-held Texas stem cell clinic, Celltex, that had given Governor Perry a stem cell transplant? I put up a poll a few days ago asking this question and the results have been striking. By way of background, it’s been a complicated few weeks for Celltex. Almost a month ago, I […]
Poll indicates major pessimism on future of Texas stem cell clinic, Celltex Read More »
It’s only Wednesday and it’s already been a big, bumpy week for Texas stem cell company, Celltex. On Monday, the FDA report of their two-week visit to/audit of Celltex became public thanks to the efforts of Dr. Leigh Turner and Houston Chronicle reporter, Todd Ackerman. Now there is more complicated news for the company. A
Celltex is sued by former employee Read More »
As I first reported, the FDA conducted a two-week audit of Texas adult stem cell firm, Celltex, sometime in April. Today I received a copy of the so-called “483 report” of that audit. It is basically a summary of problematic issues that the FDA says need to addressed. The FDA report is cause for some
Surprising FDA audit report of Celltex a blow to dubious stem cell clinics Read More »
Celltex is an adult stem cell company in the great state of Texas that reportedly has produced adult stem cell products used for the treatment of more than 100 patients with stem cells. We don’t know much about Celltex (e.g. it has no website), but I was hoping to change that in part via a
Predictions heat up on FDA audit of Celltex Read More »
What are the top 10 stem cell events of a crazy 2012 to date? Based on this wild list in just over 3 months, I would say 2012 overall will prove to be a memorable one. 1. Celltex and McGee versus University of Minnesota’s Turner and Elliott. Glenn McGee, at one point both editor of American
Stem cell stories of a crazy 2012 so far including Celltex Read More »
The Texas State Medical Board reportedly approved new rules for the use of adult stem cells. The ruling was at least in part a result of Texas Governor and former GOP presidential hopeful, Rick Perry, strongly pushing the issue. Perry himself received a controversial, non-FDA approved stem cell transplant in 2011 as part of a
Rick Perry’s Texas two step spin on stem cells Read More »
Are stem cells a drug? Should the FDA regulate them? Technically, the FDA calls stem cells “biologics”, but the FDA regulates stem cell products with the goal of ensuring safety and efficacy much the same as traditionally define chemical “drugs”. You can learn more about the FDA’s view of and concerns about stem cells here and here.
Are stem cells drugs? Read More »
In a strange, but fascinating tale recounted by Antonio Regalado in an article over at MIT Tech Review, we hear the first claim of a do-it-yourself (DIY) gene therapy involving a firm called BioViva and its leader Liz Parrish. Liz Parrish and BioViva The owner of a small biotech called BioViva, Liz Parrish, reportedly traveled
Claim of Liz Parrish DIY gene therapy linked to unlicensed stem cell clinic Read More »
This is the fourth post in a series I’m doing on an FOIA release of letters between Texas stem cell clinic Celltex and the FDA. The first three posts, which include helpful background and discussion of other FOIA material from Celltex, can be found here, here, and here. Today’s post is focused on a newly
Celltex FDA FOIA Letter #3 Raises Key New Questions Read More »