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

密歇根-匹兹堡-维斯再生医学资源中心：推进牙科、口腔和颅面再生以启动临床试验

• 批准号: 10615889
• 负责人: WILLIAM V GIANNOBILE
• 金额: $ 628.23万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10615889
• 关键词: Acceleration; Address; Adoption; Area; California; Catalysis; Clinical; Clinical Trials; Collaborations; Communities; Community Medicine; Companions; Congenital Disorders; Dental; Dentistry; Development Plans; Disease; Extramural Activities; Funding; Goals; Human; Industrialization; Industry; Infrastructure; Injury; Institution; Marketing; Medicine; Michigan; National Institute of Dental and Craniofacial Research; Natural regeneration; Oral; Pathway interactions; Patient Care; Private Practice; Probability; Process; Regenerative Medicine; Resources; Risk; Secure; Services; Standardization; Structure; System; Technology; Tissue Engineering; Translating; Translations; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Vision; Work; clinical development; clinical implementation; clinical practice; clinical translation; cohort; commercialization; craniofacial; craniofacial tissue; empowerment; first-in-human; forging; functional restoration; innovation; novel; oral tissue; organ regeneration; organizational structure; outreach program; pre-clinical; preclinical study; product development; programs; reconstruction; restorative dentistry; success; technology validation; tissue regeneration; training opportunity

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.

项目概要 通过组织工程和再生重建牙齿、口腔和颅面 (DOC) 组织 医学（RM）是牙科的一个主要目标。尽管 RM 持续取得成功并具有商业可行性 在某些医学领域中，RM 概念在 DOC 问题上的应用尚未得到很好的应用。 落实到临床实践中。为了满足这一需求，密歇根-匹兹堡-维斯再生医学中心 资源中心（MPWRM RC）是作为大学之间的跨学科合作伙伴关系而建立的 密歇根州、匹兹堡大学和 Wyss 研究所，以及技术、临床、监管、 来自私人执业和行业的营销和商业翻译专家。通过这次合作 努力，我们将通过提供跨学科专业知识来加速有前景技术的临床应用 以及指导技术向 FDA 提交的资源。 该 RC 的愿景是安全有效地再生、重建和恢复功能性 DOC 组织。 为了实现这一愿景并实现 DOC 组织再生联盟 (DOCTRC) 的目标，我们将继续 与 NIDCR 签订的第 3 阶段合作协议旨在：1) 实施已开发的 RC 结构和流程 在第二阶段，促进跨学科转化项目（ITP）走向临床应用； 2）直接临床 ITP技术的转化和商业化； 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，我们建立了战略合作伙伴关系，建立了 基础设施以及综合评估和咨询流程，以支持 DOCTRC 第 2 阶段的 19 个 ITP 倡议。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 在这组项目中，有 7 个项目已被确定为第 3 阶段 ITP 计划第一批的候选项目，其中 成熟后进入第三阶段的其他项目的子集。这些项目代表了一个平衡的投资组合 尊重所解决的临床需求和技术类​​型，以及相应的产品开发途径。 DOCTRC 计划第三阶段完成后，我们将推出一系列具有以下特点的技术： FDA 提交和商业化的相关风险范围，直至最终的临床采用。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。影响 这些努力将促进 DOC 领域的翻译，以前在 NIH 中从未实现过 校外项目，导致牙科、口腔和颅面医学的变革。

项目成果

A Quantification of Scalp Thickness before and after Posterior Vault Distraction Osteogenesis.

后穹窿牵引成骨前后头皮厚度的量化。

• DOI: 10.1097/prs.0000000000008767
• 发表时间: 2022
• 期刊: Plastic and reconstructive surgery
• 影响因子: 3.6
• 作者: Zapatero,ZacharyD;Morales,CarrieZ;Wes,AriM;Kalmar,ChristopherL;Kosyk,MychajloS;Swanson,JordanW;Bartlett,ScottP;Taylor,JesseA
• 通讯作者: Taylor,JesseA

Biodegradable Nerve Guide with Glial Cell Line-Derived Neurotrophic Factor Improves Recovery After Facial Nerve Injury in Rats.

含有胶质细胞系衍生神经营养因子的可生物降解神经导管可改善大鼠面神经损伤后的恢复。

• DOI: 10.1089/fpsam.2022.0346
• 发表时间: 2023
• 期刊: Facial plastic surgery & aesthetic medicine
• 影响因子: 2
• 作者: Bengur,FuatBaris;Komatsu,Chiaki;Fedor,CarolineNadia;Loder,Shawn;Baker,JocelynS;Totwani,Aanchal;Irgebay,Zhazira;Nerone,WVincent;Solari,MarioG;Marra,KaceyG
• 通讯作者: Marra,KaceyG