Michigan Regenerative Medicine Resource Center

 描述(由申请人提供)：修复因疾病、损伤或先天性疾病而丢失的牙齿、口腔和颅面(DOC)组织是口腔重建治疗的主要目标。组织工程(TE)和再生医学(RM)提供了强大的潜力，为患者提供更可预测、更少侵入性和个性化的治疗。该资源中心(RC)的目标是通过开发和翻译与临床相关的TE/RM技术来改变因疾病或损伤而导致的DOC畸形的治疗。我们实现这一目标的愿景是整合生命科学和工程技术的进步，在具有翻译基础设施的环境中解决临床定义的问题。履行 这一愿景将使牙科行业发生变革，使密歇根州成为再生DOC疗法的全国领先者，并将成为该地区的经济引擎。为了推动TE/RM技术向临床领域的转化，并实现这一RFA的目标，需要对TE/RM的实践进行转变。为此，我们将建立一个由密歇根州、临床实践社区和哈佛/威斯研究所的研究人员组成的互动、多学科团队。该团队将制定一个组织结构和操作程序，以建立一个集中的RC，以确定最有希望用于临床应用的TE/RM技术。通过建立致力于共同愿景的多学科团队，我们的RC将使技术在翻译管道中取得进展。为了实现这一愿景，在这项规划拨款中，我们将：1)开发一个组织结构，以选择可再生的策略，以转化为临床实践。中国证监会将利用 密歇根大学现有的优秀临床实践关键意见领袖(KOL)和哈佛/威斯研究所，以及密歇根州TE/RM的翻译基础设施和行业合作伙伴组成了一个协调的团队。该团队将致力于选择最科学、临床和商业适用的DOC组织再生策略。2)建立一支支持和基础设施团队，以推动选定战略的技术进步。RC将协调高质量的技术支持和研究基础设施，致力于指导密歇根州和其他RC的TE/RM调查人员如何测试和验证技术，标准化程序并与现有技术进行比较，以及定义适当的端点和功能结果。3)建立团队和操作程序，以支持选定TE/RM技术的临床翻译。我们将组织：a)总结人类疾病和损伤情况的临床相关临床前动物模型的应用；b)制作方案；c)FDA的法规专业知识和I/II期试验方案的开发；d)临床实践翻译的临床DOC专业知识。

 DESCRIPTION (provided by applicant): Restoration of dental, oral and craniofacial (DOC) tissues lost to disease, injury or congenital disorders is a major goal of oral reconstructive therapy. Tissue engineering (TE) and regenerative medicine (RM) offer strong potential to yield more predictable, less invasive and personalized treatments for patients. The goal of this Resource Center (RC) is to transform the treatment of DOC deformities due to disease or injury through the development and translation of clinically-relevant TE/RM technologies. Our vision to achieve this goal is to integrate advances in life science and engineering technologies to solve clinically-defined problems in an environment having a translational infrastructure. Fulfillment of this vision will enable dentistry to be transformed, will establish Michigan as a national leader i regenerative DOC therapies, and will serve as an economic engine for the region. To advance translation of TE/RM technologies to the clinical arena and fulfill the goals of this RFA, a shift n thought regarding the practice of TE/RM is required. Towards this end, we will establish an interactive, multidisciplinary team comprised of investigators at Michigan, the Clinical Practice Community and Harvard/Wyss Institute. This team will develop an organizational structure and operational procedures for establishing a centralized RC for identifying the most promising TE/RM technologies for clinical application. By establishing multidisciplinary teams working toward a common vision, our RC will enable technologies to progress through the translational pipeline. To achieve this vision, in this planning grant, we will: 1) Develop an organizational structure to select regenerative strategies to translate to clinical practice. The RC will leverage existing excellence at the University of Michigan, Clinical Practice Key Opinion Leaders (KOLs) and Harvard/Wyss Institute, along with Michigan's translational infrastructure in TE/RM and industrial partners to form a coordinated team. This team will be dedicated to selecting the most scientifically sound, clinically and commercially applicable strategies for the regeneration of DOC tissues. 2) Develop a support and infrastructure team for technical advancement of selected strategies. The RC will orchestrate high quality technical support and a research infrastructure dedicated to guiding TE/RM investigators at Michigan and other RCs on how to test and validate technologies, standardize procedures and compare to existing technologies, and define appropriate endpoints and functional outcomes. 3) Develop teams and operating procedures to support the clinical translation of selected TE/RM technologies. We will organize: a) the application of clinically relevant pre-clinical animal models that recapitulate human disease and injury conditions; b) manufacturing protocols; c) FDA regulatory expertise and protocol development for Phase I/II trials and d) clinical DOC expertise for clinical practice translation.