Is the Sugar Land-based company Celltex associated with Governor Rick Perry’s stem cell operation at risk of shutting down? It’s possible.
A preliminary report published after an extensive U.S. Food and Drug Administration investigation sheds light on 79 of Celltex Therepeutics Corp.’s transgressions, reported the Houston Chronicle’s Todd Ackerman. Among the operation’s faults is its failure to “assure batch uniformity and integrity” of the mesenchymal stem cells it has stored.
What exactly does Celltex do?
Basically, it specializes in the storage and processing of stem cells to be reinjected into patients upon a doctor’s request. David Eller, cofounder and CEO of Celltex, told the Chronicle in March that the company does not “administer” stem cells. Rather, the company “stores and processes them at the behest of doctors who later reinject them into patients,” Ackerman wrote.
So wait, why did the FDA investigate Celltex?
Back in February, a University of Minnesota bioethicist named Leigh Turner * wrote an eight-page letter to the government agency urging them to investigate the nature of Celltex’ procedures, saying “It appears their business plan involves injecting or infusing on a for-profit, commercial basis non- FDA-approved adult stem cells into paying customers.” He wrote on February 21 that “this plan conflicts with FDA regulations governing human stem cells.”
The FDA report, released to the Chronicle on Monday in response to a Freedom of Information Act request, contains fourteen observations about Celltex’ operations further explained in 79 bullet points.
Paul Knoepfler is an associate professor in Cell Biology and Human Anatomy at the