Austin | Dallas | Houston
Science Battle

Controversial Sugar Land stem cell lab to fight FDA warning: Rick Perry's boys not backing down

Enlarge
Slideshow
News_Tyler_stem cell clinic_Sugar Land
Celltex, the Sugar Land company behind Rick Perry's unlicensed stem-cell treatment in 2011, is under fire by the FDA. Photo by Tyler Rudick
Snuppy, cloned dog, clone
Celltex offers an advanced culturing procedure developed by RNL Bio — the lab behind Snuffy, the world's first cloned dog (see puppy to the right). Nature.com
News_Tyler_stem cell clinic_Sugar Land
The company's Houston area facility is the largest in North American at 15,000 square feet. Photo by Tyler Rudick
News_Tyler_stem cell clinic_Sugar Land
Snuppy, cloned dog, clone
News_Tyler_stem cell clinic_Sugar Land

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.

Newsletters for exploring your city

Daily Digest

Houston news, views + events

The Dining Report

News you can eat

Insider Offers

Curated experiences at exclusive prices

Promo Alerts

Special offers + exclusive deals

We will not share or sell your email address