The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.
In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.
"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.
The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.
The report, partially redacted, was not accompanied by a warning letter.
A former FDA official who read it, however, said the deficiencies -- 79 in all, from incorrectly labeled products to failed sterility tests -- are so serious that Celltex risks being shut down if it does not remedy the problems quickly. The former official asked not to be identified.
Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.
Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.
Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.
In April, the Texas Medical Board approved rules regulating the therapy, which isn't approved by the FDA. The rules allow doctors to use stem cells as long as they get the approval of a review board that evaluates clinical research for safety. The board members were all appointed by Perry.
Those rules will be published in the Texas Register and begin taking effect Friday.
A spokesperson for Perry called the report a matter "between the company and FDA." In a statement, she said Perry's surgery was "a success" and "he remains committed to supporting adult stem cell research and the safe implementation of its therapies in Texas, which hold the promise of improving and saving lives."