The National Institute of Dental and Craniofacial Research (NIDCR) has formed a pair of 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, these 3-year awards will support the development of 2 resource centers as part of the NIDCR’s Dental, Oral, and Craniofacial Tissue Regeneration Consortium (DOCTRC), an initiative designed to shepherd new therapies through preclinical studies and into human clinical trials.
DOCTRC’s ultimate goal is to develop strategies and devices to 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, DDS, PhD. “DOCTRC is designed as a model for optimizing translation of scientific advances in the field.”
Few DOC therapies based on regenerative medicine have been commercialized and reached the clinic to date. An analysis of NIDCR’s research portfolio has identified barriers to the process, and DOCTRC was established to address them and build on the strength of existing research using approaches such as the following:
An enhanced focus on clinical needs and involvement of practicing clinicians to inform the design of new therapies;
Development of approaches to generate multitissue 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 comprises 3 stages. Stage 1, a one-year planning stage, was successfully completed in 2016. Among proposals submitted for Stage 2, a pair of groups received awards to develop the resource centers during the next 3 years.
These 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 the 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 applications with the Food and Drug Administration (FDA) 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, PhD, program director of NIDCR’s Tissue Engineering and Regenerative Medicine Research Program.
“By establishing 2 national cores to support the regenerative medicine research community, DOCTRC represents a new paradigm in translational medicine,” said Lumelsky.
Research strategies can be material-based, cell-based, drug delivery, or combinations of these approaches. Some current research, for example, uses tiny polymer-based scaffolds that are implanted to promote the growth of damaged bone or periodontal tissue that supports teeth or tooth replacement dental implants.
The funding will support the Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration (C-DOCTOR), driven by an alliance of 6 California universities and private partners, and the Michigan-Pittsburgh-Wyss Resource Center: Supporting Regenerative Medicine in Dental, Oral, and Craniofacial Technologies, comprising academic and corporate entities.
“The institutions in the C-DOCTOR consortiums are pioneers in stem cells and regenerative medicine, and many projects at various stages of research and development at the University of California Los Angeles (UCLA) and other institutions and companies nationwide will benefit from the amazing C-DOCTOR resources,” said Ben Wu, DDS, PhD, UCLA’s principal investigator and chair of its division of advanced prosthodontics.
“We are hopeful that these efforts will improve the lives of our patients who suffer from birth defects, trauma, and other conditions that affect the skull, facial bones, teeth, and facial soft tissue structures,” said Ophir Klein, MD, PhD, director of the program in craniofacial biology at the University of California San Francisco School of Dentistry, a member of C-DOCTOR.
“The purpose of the center is to vet technologies. And not only vet them scientifically but vet them clinically: Is this scaffold going to solve a compelling clinical problem?” said David Kohn of the University of Michigan’s department of biologic and materials sciences and its College of Engineering. The university is part of the Michigan-Pittsburgh-Wyss Resource Center.
“Vet them in terms of manufacturing: Can this be manufactured?” Kohn continued. “Can it be manufactured to FDA standards? Vet them in terms of commercialization: Is anyone going to invest and buy this?”