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Texas Medical Board advances regulations on experimental stem cell use
NEWS IN BRIEF — Posted Feb. 27, 2012
The Texas Medical Board is revising its standards for use of investigational agents to encompass experimental human stem cell use.
The proposed rule lists investigational agents as medications, biological agents, devices, diagnostic products and treatment regimens not approved by the Food and Drug Administration.
"Use of stem cells in humans shall be considered investigational unless they are used in the conduct of an FDA-approved protocol or until such time as they are approved by the FDA," the rule says.
The change comes after Texas Gov. Rick Perry underwent experimental therapy in which he had his stem cells injected into his back during spinal surgery in July 2011, sparking debate about the efficacy of such treatments.
Under the rule, physicians using investigative agents must follow protocols approved by the FDA, National Institutes of Health or an Institutional Review Board. Studies must be overseen by a principal investigator, with written objectives disclosed to patients.
The board gave the changes initial approval Feb. 10. The proposed revisions will be published in the Texas Register for public comment probably on March 9, a board spokeswoman said.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/02/27/prbf0227.htm.
