FDA issues warning to Sugar Land stem cell company

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

The subject of many nonprofit academic clinical trials, they are also being used as therapy by some for-profit companies, at steep prices.

Celltex, for instance, charges $20,000 and up.

It has attracted attention since it was revealed Dr. Stanley Jones treated Perry with his own stem cells during back surgery in July 2011 and in follow-up appointments. Before their reinjection, Perry's stem cells were stored and grown at Celltex.

A Perry spokeswoman called the matter "between Celltex and the FDA."

Review board warned

The FDA letter could affect a controversial decision by the Texas Medical Board allowing doctors to use stem cell therapy as long as they get the consent of the patient and the approval of a review board that evaluates clinical research for safety.

"I think this FDA letter sends the message that the FDA isn't going to tolerate the unlicensed use of stem cells as therapy," said Paul Knoepfler, a University of California Davis School of Medicine professor of biology who conducts research on stem cells. "Obviously, federal law supersedes state law."

The FDA also sent a warning letter to Texas Applied Biomedical Services, the review board that Celltex has used to comply with the state regulations. Citing a conflict of interest involving two members who participated in the drafting of protocol documents and their review and approval, the letter said the FDA would withhold approval of all new studies reviewed by Texas Applied Biomedical Services and ordered it not to enroll new subjects in clinical trials.

Eller said in the news release that Celltex has enrolled 200 patients in such trials.

A Texas Medical Board spokeswoman said the agency could reopen the matter at its November meeting. Until then, she said, it would require a complaint to investigate unlicensed stem cell therapy.

todd.ackerman@chron.com