Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center: Advancing Dental, Oral, and Craniofacial Regeneration to Clinical Trial Initiation

项目总结 牙科、口腔和颅面(DOC)组织的组织工程和再生重建 医学(RM)是牙科的一个主要目标。尽管rm的持续成功和商业可行性 在选定的医学领域，将RM概念应用于DOC问题一直不是很好。 在临床实践中实施。为了满足这种需求，密歇根-匹兹堡-威斯再生医学 资源中心(MPWRM RC)是作为加州大学之间的跨学科伙伴关系而建立的 密歇根大学、匹兹堡大学和怀斯研究所，以及技术、临床、监管、 来自私人执业和行业的市场营销和商业翻译专家。通过此协作 努力，我们将通过提供跨学科的专业知识来加速有前途的技术的临床采用 和资源，以指导技术向FDA提交。 该RC的愿景是安全有效地再生、重建和恢复功能性DOC组织。 为了实现这一愿景和实现DOC组织再生联盟(DOCTRC)的目标，我们将继续 此与NIDCR的合作协议第三阶段：1)实施所开发的RC结构和流程 在第二阶段催化跨学科转换项目(ITP)走向临床采用；2)指导临床 ITP技术的翻译和商业化；以及3)扩大DOCTRC的影响和建立可持续性。 每一项工作都将与口腔和颅面组织中心合作进行 器官再生(C-医生)，我们的同伴RC。 根据与NIDCR的合作协议和伙伴关系，我们建立了战略伙伴关系，建立了 基础设施以及综合评估和咨询进程，以支持DOCTRC第二阶段的19个信息技术方案 主动权。所有项目都超越了基本发现，并迅速进行了可证明的临床前概念验证 成熟的产品开发和商业翻译路线图，以及强大的临床影响潜力。从… 这一套，7个项目已被确定为第三阶段ITP方案的初始队列的候选项目，具有 进入第三阶段的其他项目的子集，随着它们的成熟。这些项目代表了一个平衡的投资组合， 针对临床需求和技术类型，以及相应的产品开发路径。 在DOCTRC计划的第三阶段完成后，我们将通过 FDA提交和商业化以及最终临床采用的相关风险范围。我们 将努力为ITP争取杠杆和后续资金，以便它们可以进入人体临床试验。最后， RC将与RM社区分享我们的方法，而不仅仅是我们投资组合中的项目。其影响 这些努力中的一项将是在DOC舞台上催化翻译，这是NIH以前从未实现的 校外计划，导致牙科、口腔和颅面医学的变革。

PROJECT SUMMARY Reconstruction of dental, oral, and craniofacial (DOC) tissues through tissue engineering and regenerative medicine (RM) is a major goal in dentistry. Despite the continuing success and commercial viability of RM approaches in selected areas of medicine, the application of RM concepts to DOC problems has not been well- implemented in clinical practice. To meet this need, the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center (MPWRM RC) was established as an interdisciplinary partnership amongst the University of Michigan, the University of Pittsburgh, and the Wyss Institute, along with technology, clinical, regulatory, marketing, and commercial translation experts from private practice and industry. Through this collaborative effort, we will accelerate clinical adoption of promising technologies by providing the interdisciplinary expertise and resources to guide technologies towards FDA submissions. The vision of this RC is to safely and effectively regenerate, reconstruct, and restore functional DOC tissues. To achieve this vision and fulfill the goals of DOC Tissue Regeneration Consortium (DOCTRC), we will continue this cooperative agreement with NIDCR for Stage 3 to: 1) implement the RC structure and processes developed in Stage 2 to catalyze Interdisciplinary Translational Projects (ITPs) towards clinical adoption; 2) direct clinical translation and commercialization of ITP technologies; and 3) broaden DOCTRC impact and build sustainability. Each of these endeavors will be done in partnership with the Center for Dental Oral and Craniofacial Tissue and Organ Regeneration (C-DOCTOR), our companion RC. Under a cooperative agreement and partnership with NIDCR, we have forged strategic partnerships, built infrastructure, and integrated assessment and advising processes, to support 19 ITPs in Stage 2 of the DOCTRC initiative. All projects are beyond basic discovery with demonstrable preclinical proof-of-concept, rapidly maturing product development and commercial translation roadmaps, and strong clinical impact potential. From this set, 7 projects have been identified as candidates for the initial cohort of the Stage 3 ITP program with a subset of other projects entering Stage 3 as they mature. These projects represent a balanced portfolio with respect to clinical needs addressed and technology types, with corresponding product development pathways. Upon completion of Stage 3 of the DOCTRC initiative, we will have advanced a portfolio of technologies with a spectrum of associated risk to FDA submissions and commercialization, towards eventual clinical adoption. We will work to secure leveraged and follow-on funding for ITPs so they may progress to human clinical trials. Finally, the RC will share our approach with the RM communities beyond solely the projects in our portfolio. The impact of these efforts will be a catalysis of translation in the DOC arena never previously achieved in an NIH extramural program, resulting in the transformation of dental, oral, and craniofacial medicine.