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Texas considers change to stem cell regulations

stem cells

A Texas agency will vote Friday on whether to enact new rules that would make it easier for doctors to offer experimental treatments using adult stem cells without federal approval.

The Texas Medical Board, which licenses and disciplines doctors in the state, recently drafted stem-cell rules at the behest of Stanley Jones, of Houston, the doctor who in July injected Gov. Rick Perry with the governor's own stem cells to try to aid his recovery from a back injury.

The governor, who appoints all the members of the Medical Board, has encouraged the agency to create rules governing adult stem-cell treatments, which involve removing a patient's stem cells and reinserting them in the hopes of aiding muscle, nerve or blood cells damaged by such conditions as cancer, osteoarthritis or multiple sclerosis.

"It is my hope that Texas will become the world's leader in the research and use of adult stem cells," Perry wrote in a July letter to the president of the Texas Medical Board.

But critics say the proposed rules give doctors too much leeway to perform stem-cell procedures that haven't been proved safe or effective.

"The guidelines are skewed to favor business interests instead of patient safety," said Leigh Turner, a bioethics professor at the University of Minnesota. Many adult stem-cell procedures, he said, are experimental and can give rise to blood clots and other complications.

The procedures in question are different from embryonic stem-cell research, which some religious and political groups oppose on the grounds that it can destroy human embryos.

But adult stem-cell procedures also have been controversial. Some, such as bone-marrow transplants, have a proven track record, but physicians increasingly seek to offer more innovative treatments that can cost thousands of dollars.

One obstacle to doctors has been the Food and Drug Administration, which requires physicians to seek the agency's approval before offering experimental, adult stem-cell treatments. Doctors complain the FDA approval process can be costly and time-consuming.

The FDA said in a statement it doesn't comment on state regulations or proposed regulations. "Our position on stem cells remains the same. The FDA has regulatory authority over human cells, tissues and/or cellular and tissue-based products."

The proposed Texas rules would allow doctors to bypass the FDA so long as they satisfy other conditions before offering certain experimental adult stem-cell treatments, including obtaining patient consent and securing approval from an independent review board.

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