Gene therapy appears safe to regenerate oral bone tissue
20 May 2009
With the support of the AO ResearchAdvisory Council among others, scientists at the University of Michigan (U-M) have developed amethod of gene delivery that appears safe for regenerating tooth-supportingbone tissue—a discovery that assuages one of the biggest safety concernssurrounding gene therapy research and tissue engineering.
“What the U-M study showed is (the topical method) is very well containedand doesn’t distribute throughout the body,” said Giannobile, who also directsthe Michigan Center for Oral Health Research and has an appointment at the U-MCollege of Engineering’s Department of Biomedical Engineering. “This approachalleviates the safety concern about negative reactions within the body.”
“When the teenager died, it got into his bloodstream and he reacted to it.It was tragic. This is the first study of periodontal disease therapy thatdemonstrates the distribution of these genes is very safe, suggesting that itcould be used in the clinic for clinical application.”
“Our study doesn’t look at all the safety concerns, but certainly this isvery important to the field. The two clinical applications to date where itshows potential are periodontal disease and diabetic wounds. Maybe the reasonfor this is that both diseases result from a compromised or a defective healingenvironment.”
“The next step for the U-M team is to use the new gene delivery approach inhuman clinical trials,” Giannobile said. The planning stages for these studieswill commence in the next year.
The paper, called “Adenovirus Encoding Human Platelet-Derived Growth Factor-B Delivered to Alveolar Bone Defects Exhibits Safety and Biodistribution Profiles Favorable for Clinical Use,” is now available online for free as part of the May 2009 issue of the journal Human Gene Therapy.
Co-authors include Po-Chun Chang, Joni Cirelli, Yang-Jo Seol, Qiming Jin, Jim Sugai, Nisha D’Silva and Theodora Danciu.