TEXAS — The Texas Medical Board today approved controversial new rules on the use of adult stem cells that have raised concerns over the possibility that Texans could receive therapies that have not yet been proven to work and that could be unsafe.
Researchers say the evidence of success of stem cell injections is anecdotal, and they advocate waiting for clinical trial results before allowing physicians to charge patients — typically tens of thousands of dollars — for the procedures.
The new guidelines allow for stem cell procedures as long as they are done for research and receive approval from an institutional review board, which can be private and for-profit. The rules also require that patients sign informed consent forms.
“I think there are some real problems with these rules,” Leigh Turner, a professor at the University of Minnesota’s Center for Bioethics told the board. “The protective mechanism that they’re focusing on isn’t going to do very much.”
The rules’ supporters acknowledged the need for changes, such as better defining “stem cells,” but they said the rules would better protect Texas patients. Procedures are being performed now without oversight.
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