NIDCR announces two new cooperative agreements aimed at developing resources and strategies for regenerating dental, oral, and craniofacial (DOC) tissues that have been damaged by disease or injury. Totaling $24 million over three years, these awards support the development of two Resource Centers as part of the NIDCR’s Dental, Oral, and Craniofacial Tissue Regeneration Consortium (DOCTRC), an initiative designed to shepherd new therapies through pre-clinical studies and into human clinical trials. The ultimate goal is to develop strategies and devices that could help repair or regenerate damaged DOC tissues, including craniofacial bone, muscle and blood vessels, nerves, teeth, and salivary glands.
"By establishing this research consortium, NIDCR seeks to lead national efforts to accelerate the translation of promising DOC regenerative medicine therapies into the clinic," said NIDCR Director Martha J. Somerman, D.D.S., Ph.D. "DOCTRC is designed as a model for optimizing translation of scientific advances in this field."
To date, few DOC therapies based on regenerative medicine have been commercialized and reached the clinic. A careful analysis of NIDCR's research portfolio identified barriers to the process, and the DOCTRC was established to address them and build on the strength of existing research, using approaches such as:
- Enhanced focus on clinical needs and involvement of practicing clinicians to inform the design of new therapies
- Development of approaches to generate multi-tissue composites rather than using a single tissue type
- Targeted translational research and early regulatory guidance
- Coordination among investigators and industry to develop, validate, and commercialize new tools and technologies
DOCTRC is composed of three Stages. Stage 1, a one-year planning phase, was successfully completed in 2016. Among proposals submitted for Stage 2, two groups received awards to develop the Resource Centers over the next three years. The Centers will bring together clinical, scientific, industrial, and regulatory experts to develop an infrastructure to deliver high-quality support to Interdisciplinary Translational Projects to be launched during Stages 2 and 3. This support will entail development of standard assays, procedures, and study models to ensure that investigators can uniformly and reliably validate the technologies.
In Stage 3, the Resource Centers will collaborate with both internal and external investigators to move projects to the point of filing Investigational New Drug or Investigational Device Exemption (IND/IDE) applications with the U.S. Food and Drug Administration and launching human clinical trials.
"The DOCTRC consortium aims to streamline translation of dental, oral, and craniofacial regenerative therapies by leveraging multidisciplinary expertise to establish a systematic and uniform research process," said Nadya Lumelsky, Ph.D., Program Director of NIDCR's Tissue Engineering and Regenerative Medicine Research Program. "By establishing two national cores to support the regenerative medicine research community, DOCTRC represents a new paradigm in translational medicine."
The following RCs will be funded for up to three years:
- Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration (C-DOCTOR)
Jeffrey C. Lotz (University of California, San Francisco), Yang Chai (University of Southern California), Yong Chen (University of Southern California), Kevin E. Healy (University of California, Berkeley), Ophir D. Klein (University of California, San Francisco), Nancy E. Lane (University of California, Davis), Michael Longaker (Stanford University), Mark M. Urata (University of Southern California), and Benjamin M. Wu (University of California, Los Angeles)
- Michigan-Pittsburgh-Wyss Resource Center: Supporting Regenerative Medicine in Dental, Oral, and Craniofacial Technologies
David H. Kohn (University of Michigan), William V. Giannobile (University of Michigan), David J. Mooney (Harvard University/Wyss Institute), Charles Sfeir (University of Pittsburgh), and William R. Wagner (University of Pittsburgh)