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Scientists at the University of Michigan (U-M) have developed a method of gene delivery that appears safe for regenerating tooth-supporting gum tissue. This discovery assuages one of the biggest safety concerns surrounding gene therapy research and tissue engineering. Gene therapy is an accepted, viable therapeutic concept, but safety is a major hurdle, said William Giannobile, DDS, professor at the U-M School of Dentistry. A few years ago, a teenager died when given the adenovirus during a gene therapy clinical trial at the University of Pennsylvania. The U-M therapy also uses the adenovirus, Dr. Giannobile said, but the approach uses local application and a much lower dose. Instead of injecting the genes into the blood vessels, where they can then travel through the bloodstream and result in unexpected and sometimes fatal reactions, U-M scientists put the genes on a localized area, directly on the tissue during surgery much like a paste. Dr. Giannobile said what the U-M study showed is this topical method is well contained and doesn’t distribute throughout the body, which alleviates the safety concern about negative reactions within the body. When the teenager died, it got into his bloodstream and he reacted to it. This is the first study of periodontal disease therapy that demonstrates the distribution of these genes is very safe, suggesting that it could be used in the clinic for clinical application. The next step for the U-M team is to use the new gene delivery approach in human clinical trials. The planning stages for these studies will commence in the next year. The study was supported by the NIH and the AO Foundation.
(Source: U-M School of Dentistry news release, April 7, 2009)
