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

牙科、口腔、颅面组织和器官再生中心 (C-DOCTOR)

• 批准号: 10617717
• 负责人: Yang Chai
• 金额: $ 652.35万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-07 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617717
• 关键词: Acceleration; Adoption; Advocate; Biocompatible Materials; Biomedical Research; Brain; Businesses; California; Center for Translational Science Activities; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Congenital Disorders; Craniofacial Abnormalities; Dental; Dentists; Development; Disease; Ecosystem; Ensure; Face; Goals; Health; Human; Incentives; Industry; Infrastructure; Institution; Laboratories; Life Experience; Los Angeles; Marketing; Medical; Methodology; Methods; Mission; National Institute of Dental and Craniofacial Research; Oral; Organ; Outcome; Patient Care; Patients; Phase I Clinical Trials; Preclinical Testing; Privatization; Probability; Procedures; Process; Protocols documentation; Regenerative Medicine; Regulation; Reproducibility; Research Personnel; Research Project Grants; Resources; San Francisco; Scientist; Sense Organs; Series; Shapes; Surgeon; Technology; Tissue Engineering; Trauma; Traumatic injury; Universities; Vision; clinical center; clinical translation; commercialization; craniofacial; craniofacial tissue; cranium; education resources; experience; improved; innovation; knowledge base; knowledge hub; knowledgebase; manufacture; oral tissue; organ regeneration; pre-clinical; preclinical study; programs; recruit; regenerative; regenerative therapy; scale up; scientific hub; success; tissue regeneration

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.

项目摘要 /摘要 牙科，口服和颅面组织和器官再生中心（C-Doctor）是公私的 联盟的重点是加速有前途的组织工程/再生医学（TE/RM）疗法 牙齿，口服和颅面（DOC）组织和器官再生到人类临床试验。我们对 C-Doctor将成为创新临床翻译的综合国家资源中心 再生技术替代对先天性疾病，创伤性损伤失去的DOC组织或器官 疾病和医疗程序。我们已经招募了具有有希望的DOC再生的跨学科团队 疗法并开发了我们为这些团队提供的全面，定制的基础设施 必要的临床，科学，技术，法规，财务，面向业务和管理资源 促进他们的IND/IDE增强活动。现在，我们建议将中心的大量资源引导到 仅推进那些最适合未满足的临床需求，市场潜力，预期的技术 患者价值和临床采用的概率很高。我们将继续为ITP团队提供充分的 专家科学家，临床医生，商业化战略家和监管顾问的定制支持为 团队完善他们的产品，完成他们的IND/IDE临床前研究，过渡到当前的良好 实验室/制造实践，用于扩大规模，制定临床研究方案，形成战略伙伴关系， 并在I期临床试验之前与FDA相互作用。因此，c- doctor将创造积极的结果 对于ITP团队，否则可能无法访问必要的知识库和所需的资源 成功。为了实现这一愿景，我们提出以下四个特定目标： 特定目的1：协调和集成C- doctor基础架构和战略合作伙伴关系 支持ITP和整体Doctrc编程函数 特定目标2：组装平衡的ITP投资组合并为ITP提供全面的支持 临床前科学研究，方案/技术方法发展，商业化策略， 以及支持IDE/IND提交和相关临床研究方案的监管相互作用 特定目标3：验证关键ITP结果并执行临床前测试，开发共享 标准操作程序，协议，最佳实践和教育的知识库 确保ITP研究的严格性和可重复性的资源，并作为知识中心 科学界 特定目的4：在C-Doctor和MPWRM之间建立强大而可持续的合作 支持ITP的开发和商业化 实现这些目标将使c doctor成为一个全面的资源网络，以支持文档te/rm 将是可持续的，并对我们改善人类健康的努力产生持久影响。