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

项目摘要 通过组织工程和再生技术重建牙齿、口腔和颅面（DOC）组织 医学（RM）是牙科学的主要目标。尽管RM的持续成功和商业可行性 在选定的医学领域的方法中，RM概念在DOC问题中的应用并不好- 在临床实践中实施。为了满足这一需求，匹兹堡再生医学中心（Pittsburgh Regenerative Medicine） 资源中心（MPWRM RC）是作为一个跨学科的合作伙伴关系之间的大学， 密歇根大学，匹兹堡大学，和威斯康星研究所，沿着技术，临床，监管， 市场营销和商业翻译专家从私人执业和行业。通过这次合作 通过努力，我们将通过提供跨学科的专业知识， 和资源，以指导技术向FDA提交。 本RC的愿景是安全有效地再生、重建和恢复功能性DOC组织。 为了实现这一愿景并实现DOC组织再生联盟（DOCTRC）的目标，我们将继续 与NIDCR在第3阶段的合作协议：1）实施RC结构和开发的过程 在第2阶段，促进跨学科转化项目（ITP）走向临床采用; 2）指导临床 ITP技术的转化和商业化;以及3）扩大DOCTRC的影响并建立可持续性。 每一项工作都将与牙科口腔和颅面组织中心合作完成， 器官再生（C-DOCTOR），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， 基础设施，以及综合评估和咨询程序，以支持DOCTRC第二阶段的19个ITP 倡议所有项目都超越了基本的发现，具有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 在这一系列项目中，有7个项目被确定为ITP计划第三阶段初始队列的候选项目， 其他项目的子集在成熟时进入第三阶段。这些项目代表了一个平衡的投资组合， 针对所解决的临床需求和技术类型，以及相应的产品开发途径。 在DOCTRC计划的第三阶段完成后，我们将推进一系列技术， FDA提交和商业化的相关风险范围，以最终临床采用。我们 将努力为ITP获得杠杆和后续资金，以便他们可以进行人体临床试验。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。的影响 这些努力将成为美国国立卫生研究院以前从未实现过的DOC竞技场翻译的催化剂 校外计划，导致牙科，口腔和颅面医学的转变。

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.