Medical board approves controversial adult stem-cell rules

By Dr. Matthew Watson

AUSTIN - The Texas Medical Board Friday approved rules regulating adult stem cell therapy, concerned that the proliferation of the experimental treatment constitutes "an emergency state."

Despite opposition from some board members concerned that its action could wind up putting more patients in danger of harm from the unproven, unlicensed therapy, the board approved a policy that allows doctors to use it as long as they get the patient's consent and the approval of a review board that evaluates clinical research for safety. The therapy has been in the news since Gov. Rick Perry received it for an ailing back last year.

"We know this is far from a perfect policy, but our hope is that this affords people in Texas seeking this therapy some protection," said Dr. Irwin Zeitler, the board president. "The wheels of the federal government move so slowly - we're not willing to wait to protect our patients."

The board, which voted 10-4 to approve the regulations, promised it would work to improve them, pledging to bring revisions to its June meeting. No date has been set for when the policy approved Friday will take effect, but it will be at least 30 days, board staff said.

The policy, thought to be the first of its kind, has drawn criticism nationally and internationally for appearing to circumvent the Food and Drug Administration and for making the therapy commercially available before it has been proven safe and effective. The treatment is not approved by the FDA and patients typically must pay tens of thousands of dollars for it.

Adult stem cells, which multiply to replenish dying cells, have long been used to treat leukemia and other cancers, but in the last decade they have shown promise for tissue repair in many other diseases. Less versatile than embryonic stem cells, they are championed by many as a more ethical alternative because no embryo is destroyed.

But they are mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

The therapy gained national attention after it was revealed Perry received it last summer. Houston surgeon Stanley Jones injected the governor during his July 1 back surgery and intravenously in follow-up appointments.

todd.ackerman@chron.com

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Medical board approves controversial adult stem-cell rules



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