Celltex Therapeutics — the Sugar Land company involved in governor Rick Perry's controversial stem-cell procedure in 2011 — has been issued a stern warning from the Food and Drug Administration for illegally selling an unlicensed product.
Filed Sept. 24 but only made public this week, the FDA warning letter came with a laundry list of other manufacturing infractions, which were noted by federal investigators during a 10-day inspection in April 2012. Failure to address these issues, ranging from poor record-keeping to unsterile lab conditions, could result in seizure or injunction.
"The FDA said our process causes the cells to be consider ed biological drugs and thus is subject to those regulations."
The crux of Celltex's troubles revolve around a federal ruling in July that allows the FDA to regulate stem-cell therapies as drugs, a decision that now permits the agency to enforce regulations against an ever-growing number of stem cell clinics and banks across the country.
"The FDA said our process causes the cells to be considered biological drugs and thus is subject to those regulations," Celltex president and CEO David Eller said in a statement. "We respectfully but firmly disagree with the FDA and intend to contest the agency’s opinion within its administrative procedures."
The company's 15,000-square-foot Sugar Land facility, which opened last December, is the largest adult stem cell lab and bank in North America, providing clients with an advanced culturing process licensed from RNL Bio — the Korean firm best known for creating Snuppy, the world's first cloned dog.
According to a price list released in late 2011, fees at Celltex start with an introductory charge of $4,873. Patients can withdraw 50 million stem cells for $1,759.
A public relations firm representing Celltex told CultureMap on Wednesday that the company will work closely with federal officials to consider its options, as it moves towards a viable resolution.
Editor's note: For a look inside Celltex, read Tyler Rudick's CultureMap exclusive.