Celltex is that adult stem cell company that treated Governor Perry and upwards of 80 other people with stem cell products that they grew in their lab in Texas.
I wonder what the leadership of Celltex is thinking right now about its FDA audit, their future, and that pesky professor/blogger in California…what’s his name?
I can’t be sure because Celltex won’t talk to me, but I think they’re having to deal with a totally new reality since Monday brought their FDA inspection report to light.
They and their stem cell products both are under the microscope. An uncomfortable position to be sure.
Their press release yesterday in reaction to their FDA audit has caused a lot of buzz and public speculation about what’s next for them.
The outlook, according to others who have gone on the record, seems gloomy.
Texas A&M Daily Post (TM Daily Post) has an article with the title:
Why Celltex Might be In Trouble
Biopolitical Times asks in an article:
Will the FDA Close Down Celltex?
In an article from Nature titled “US drug regulator audits Texas stem-cell company” the authors say (amongst a slew of negative statements):
Another shoe is yet to drop (on Celltex).
The Chronicle of Higher Education lead on a story on Celltex with the title:
FDA Inspectors Pound Celltex
Since Celltex won’t talk to me, I asked some people in the field for their perspectives on what this all means.
Still today most won’t go on the record, which says something.
However, a longtime, very famous (and hence anonymous) stem cell expert told me this:
Remember XCell and how we wondered how on earth they could perform untested stem cell “therapies” in a first-world country? I learned from my German colleagues that they were working legally under a system that allows physicians to have a great deal of leeway in how they treat their patients. This allowed physicians in Germany to transplant stem cells to patients if they said that they thought it might be in the best interest of their patients. This is what worries me- Texas is sounding a great deal like Germany- putting faith in physicians to treat patients by whatever means they think might help. Physicians are not experts in stem cells and there is no expert body (short of the FDA) that can legitimately give useful guidance to them. Germany had oversight over XCell in much the same way that Texas proposes to have oversight over CellTex and its kin. XCell, in spite of their oversight, killed at least two patients, and only then did the government shut them down. It was quite an embarrassment for Germany. The founder of XCell has moved his operations to Lebanon- I don’t think that is because he expects to receive better oversight there…
I don’t necessarily agree with this comparison, but it is interesting and raises the important broader question: what is the appropriate level of oversight?
It may take years to answer that question.
So a more pressing, immediate question is what’s next for Celltex.
The consensus is that there is a second boot yet to fall on Celltex from the FDA and I could not find one person who thought the Celltex spin in their press release did them any good. If anything it might just accelerate further steps by the FDA.
Note. I want to take this opportunity to point out that there are numerous other adult stem cell companies that are doing their utmost to comply with regulatory guidelines and always have and in my earlier posts of this week and quote to the Houston Chronicle I did not mean to suggest otherwise.