Under fire from the Food and Drug Administration, the Houston-area company that facilitated Gov. Rick Perry's controversial 2011 stem-cell treatment has stopped providing doctors with the cells patients banked at its facility for the procedure.
In a response to an FDA warning that it is acting illegally by marketing the unlicensed therapy, Celltex Therapeutics Corp. wrote the federal agency this week that it has ceased enrolling patients in the clinical trials the state requires of stem-cell providers. Celltex was the Houston area's primary sponsor of such for-profit trials.
"We're telling potential patients that we will still bank their stem cells but that we can't sponsor the required trials until we're in compliance with the FDA," said Andrea Ferrenz, Celltex's executive vice president and legal counsel. "We hope that will be in a matter of months."
Ferrenz called the FDA warning letter, publicly posted Tuesday, "a disappointment" but said it actually just moves up Celltex's plan to move into agency-approved trials targeting specific disease conditions. The Sugar Land company had been operating for nearly 18 months facilitating adult stem-cell procedures with little regulation.
The Texas Medical Board in July began requiring that any stem-cell procedure be reviewed for patient safety by a board expert at such evaluations. The board used by Celltex, Texas Applied Biomedical Services, last month received an FDA warning letter of its own, informing it the agency will withhold approval of all its reviews because of problems with the review board's operations, such as members with conflicts of interest.
FDA warning letters are considered big deals in drug regulation, the federal agency's principal means of achieving compliance. They include language that failure to take corrective action can result in company seizure or shutdown.
It is unclear if the FDA letters to Celltex and the review board will have an effect on the new medical board rules, meant to regulate the experimental therapy in the absence of oversight from the FDA. A medical board spokeswoman said this week that the board could reopen the matter at its November meeting.
Leigh Turner, a University of Minnesota bioethicist who writes frequently about stem-cell tourism and in February complained to the FDA that Celltex is "a potential danger to patients" and not in compliance with federal law, said he thinks it's "highly unlikely" that Celltex could quickly meet FDA requirements for research trials. He said Celltex would need to make a dramatic reconfiguration considering all the deficiencies an FDA inspection found in April.
Those included numerous basic manufacturing problems, all reiterated in the warning letter. Ferrenz said Celltex is eager to meet with FDA officials to learn what they still want to know beyond the "tons of information" the company has already sent.
Celltex had argued stem-cell injections are like bone marrow transplants and not subject to the FDA's jurisdiction. But in its warning letter, the FDA said Celltex's processing "alters the original relevant characteristics" of the cells and hence doesn't meet its requirement that living cells only be "minimally manipulated." It categorized the stem cells stored and treated at Celltex as biologic drugs.
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Houston company ceases supplying stem cells