HOUSTON (AP) – The U.S. Food and Drug Administration has issued a new report criticizing the Texas company that stored adult stem cells from Texas Gov. Rick Perry for use in an experimental procedure for his back pain, according to a newspaper report Monday.
An FDA report obtained by the Houston Chronicle said CellTex Therapeutics cannot guarantee the stem cells it takes from patients remain sterile and alive. The nine-page report dated April 27 says the lab, located in the Houston suburb of Sugar Land, does not have procedures to prevent contamination of products that are supposed to be sterile.
The report also says the lab didn’t have written records of investigations into the failure of a batch of cells. It also says the lab has not marked some lab products properly.
“The deficiencies identified reflect significant problems, serious issues,” said Paul Knoepfler, an associate professor at the University of California-Davis School of Medicine, in an interview with the newspaper. “If I were a patient, they would scare me off big time.”
CellTex was thrust into the news last year when Perry, then running for the Republican nomination for president, revealed that he had stem cells taken from fat in his body, grown in a lab and then injected into his back during a July operation to address his back pain.
Perry’s stem cells were stored and grown at CellTex, the Chronicle reported. The firm is co-owned by Dr. Stanley Jones, Perry’s friend who performed the operation.
Subsequently, the Texas Medical Board approved new rules on similar experimental stem cell therapies. Perry appointed the board. The FDA has not approved any adult stem cell therapies for orthopedic use, but experimentation by doctors in the U.S. and abroad is common.
Some scientists tout possible benefits of stem cell treatments, including treatment for heart disease, diabetes and some cancers. Others argue adult stem cell experimentation actually increases the risk of cancer and can cause blood clots.
A Perry spokeswoman called Perry’s surgery a “success” and reaffirmed his commitment to adult stem cell research. She said the FDA report was between the agency and CellTex.
CellTex CEO David Eller said the company invited the FDA inspection, which took place over nearly two weeks in April, according to the report.
“The FDA is already aware we have resolved many of its observations and we are working to address the remainder,” Eller said in a statement.
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