U-M prof to address FDA for approval of periodontal tissue engineering

ANN ARBOR—University of Michigan professor William Giannobile is one of three presenters slated to address a Food and Drug Administration (FDA) committee Tuesday seeking approval for a new treatment for periodontal disease using human growth factors.

Giannobile began working with the research team that would become BioMimetic Pharmaceuticals while he was a graduate student at Harvard in the early 1990s. Today the

U-M professor of dentistry is a founding scientific advisory board member for BioMimetic, which is seeking the FDA approval.

BioMimetic will meet for a full day with the Dental Products Panel of the Medical Devices Advisory Committee of the FDA. The panel will consider a fully synthetic regeneration system developed to treat bone defects of the jaw in patients with advanced periodontal disease, as well as other cranio-maxillofacial needs. Using human growth factors and a scaffolding that the body eventually reabsorbs, the method is intended to help the body regrow bone where the original has deteriorated.

The company recently completed and filed with the FDA a 180-patient double-blind, randomized controlled trial to evaluate the safety and efficacy of the tissue engineering approach to the regeneration of bone and other periodontal tissues. The human trials were conducted at 11 clinical centers, including the University of Michigan under the direction of David Sarment, a clinical assistant professor of dentistry.

As an investigator of the technology, Giannobile plans to present the FDA with comments about the safety and biological basis for this kind of treatment. He is not the inventor of the technology the FDA will review; he did develop a new diagnostic tool used in the human trials.

"The big challenge with existing therapies is they aren’t predictable," said Giannobile, also an associate professor of biomedical engineering and director of the Michigan Center for Oral Health Research. "They don’t work the same way every time, and the magnitude of the results are suboptimal."

This system, licensed to BioMimetic by Harvard, aims to stimulate clinical reattachment of the tissue around the teeth through regeneration of new bone.

Related links:

For more on Giannobile, visit: http://ipumich.temppublish.com/public/experts/ExpDisplay.php?ExpID=286

The Federal Register for the FDA meeting: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-13726.pdf

BioMimetic: http://www.biomimetics.com/