Science Battle

Controversial Sugar Land stem cell lab to fight FDA warning: Rick Perry's boysnot backing down

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

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 considered 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.

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Thanks, Queen Bey

Pop icon Beyoncé donates $100,000 to University of Houston Law School

Photo by Erza Shaw Getty Images

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Pop megastar Beyoncé Knowles-Carter has donated $100,000 to the University of Houston Law Center Criminal Justice Clinic through her BeyGOOD Foundation. The gift will allow the clinic to hire fill-time faculty to head it, benefiting the students who study there.

“I am delighted that the BeyGOOD Foundation has made this very generous gift to the UH Law Center,” said Leonard Baynes, dean of the UH Law Center. “Not only will this funding help establish a full-time criminal justice clinic that provides pro bono legal services in our community, but it will also supercharge our already excellent criminal law and justice programming.”

The clinic is one of nine at UHLC. It helps students learn to navigate the criminal justice system, especially on behalf of clients that are underserved by skilled attorneys. People of color are affected disproportionately by a lack of good, ethical representation.

Beyoncé, the most decorated artist in Grammy history and easily the biggest musical star native to Houston, has a long history of advocating for criminal justice reform. She was a staunch supporter of the police reform following the deaths of Alton Sterling and Philando Castile, asking law enforcement to “stop killing us” in a web post. In 2020, she penned an open letter to the Kentucky attorney general asking for justice in the death of Breonna Taylor.

Through her BeyGOOD Foundation, established in 2013, Beyoncé has focused mostly on expanding the prospects of Black-owned business and offering education opportunities to students. Forwarding the cause of legal representation in Texas while also helping out marginalized communities compliments her other philanthropic work.

“At UH Law, we envision a legal profession where ‘everyone has the opportunity to prosper,’ as BeyGOOD envisions, and we will achieve this vision by providing access to strong and effective legal representation in criminal proceedings,” Baynes said. “And together, through this gift, the BeyGOOD Foundation and UHLC will shepherd the next generation of criminal justice attorneys in the city of Houston, the state of Texas and the nation.”

Science Battle

Controversial Sugar Land stem cell lab to fight FDA warning: Rick Perry's boysnot backing down

Thanks, Queen Bey

Pop icon Beyoncé donates $100,000 to University of Houston Law School

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