Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration (C-DOCTOR)

项目摘要/摘要

PROJECT SUMMARY / ABSTRACT The Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C-DOCTOR) is a public-private consortium focused on accelerating promising tissue engineering/regenerative medicine (TE/RM) therapies for dental, oral, and craniofacial (DOC) tissue and organ regeneration to human clinical trials. Our overall vision for C-DOCTOR is to be a comprehensive national resource center for the clinical translation of innovative regenerative technologies to replace DOC tissues or organs lost to congenital disorders, traumatic injuries, diseases, and medical procedures. We have recruited interdisciplinary teams with promising DOC regeneration therapies and developed the comprehensive, customized infrastructure through which we provide these teams the necessary clinical, scientific, technical, regulatory, financial, business-oriented, and managerial resources to facilitate their IND/IDE-enabling activities. We now propose to direct the Center's considerable resources to advance only those technologies that optimally align with unmet clinical needs, market potential, anticipated patient value, and high probability of clinical adoption. We will continue to provide ITP teams with fully customized support from expert scientists, clinicians, commercialization strategists and regulatory advisors as the teams refine their products, complete their IND/IDE-enabling preclinical studies, transition to current good laboratory/manufacturing practices for scale-up, develop clinical study protocols, form strategic partnerships, and interact with the FDA ahead of Phase I clinical trials. As such, C-DOCTOR will create positive outcomes for ITP teams that may not otherwise have access to the requisite knowledgebase and resources necessary to be successful. To achieve this vision, we propose the following four Specific Aims: Specific Aim 1: To coordinate and integrate C-DOCTOR infrastructure and strategic partnerships to support ITPs and overall DOCTRC programmatic function Specific Aim 2: To assemble a balanced ITP portfolio and provide comprehensive support to ITPs for pre-clinical scientific studies, protocol/technical methodology development, commercialization strategy, and regulatory interactions supporting IDE/IND submission and associated clinical study protocols Specific Aim 3: To validate key ITP results and perform preclinical testing, developing a shared knowledge base of standard operating procedures, protocols, best practices, and educational resources to ensure rigor and reproducibility of ITP research and serve as a knowledge hub for the scientific community Specific Aim 4: To build a strong and sustainable collaboration between C-DOCTOR and MPWRM to support the development and commercialization of ITPs Achieving these aims will make C-DOCTOR a comprehensive resource network to support DOC TE/RM that will be sustainable and have a long-lasting impact on our efforts to improve human health.