Tufts Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC)

塔夫茨大学牙科、口腔和颅面组织再生联盟 (DOCTRC)

• 批准号: 9001516
• 负责人: Andrew Hoffman
• 金额: $ 20.63万
• 依托单位: TUFTS UNIVERSITY BOSTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-08 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9001516
• 关键词: Achievement; Address; Animal Model; Area; Award; Biocompatible Materials; Biological Assay; Biomedical Engineering; Cells; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Communication; Complex; Conduct Clinical Trials; Craniofacial Abnormalities; Dental; Dental Schools; Development; Development Plans; Devices; Disease; Engineering; Ensure; Environment; Equilibrium; Equipment; FDA approved; Faculty; Goals; Grant; Human; Industry; Injury; Investigational Drugs; Knowledge; Marketing; Medical center; Natural regeneration; Nursing Faculty; Oral; Outcome; Output; Patient Care; Patients; Phase I Clinical Trials; Positioning Attribute; Preclinical Testing; Procedures; Process; Production; Productivity; Protocols documentation; Records; Recruitment Activity; Regenerative Medicine; Research; Research Infrastructure; Research Personnel; Research Support; Resources; Scientist; Side; Source; Staging; Standardization; Stem cells; Structure; Time; TimeLine; Tissue Engineering; Tissues; Tooth structure; Training; Universities; Validation; Veterinary Medicine; Vision; Work; Xerostomia; base; bench to bedside; clinical application; clinical practice; craniofacial; craniofacial repair; efficacy testing; improved; innovation; manufacturing scale-up; medical schools; meetings; member; organizational structure; preclinical study; product development; public health relevance; repaired; scale up; success; tissue regeneration; translational medicine

 DESCRIPTION (provided by applicant): This Stage 1 Planning Grant will develop an overall vision, roadmap, organizational structure and operational procedures for a centralized Tufts Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC) Resource Center (RC). At the completion of this 1-Year Stage 1 Grant, the Tufts DOCTRC organizers will have developed detailed plans for establishing interactive, interdisciplinary DOC-RC teams of biologists, bioengineers, clinicians and other technical experts. This effort will be driven by practicing clinicians involved in everyday DOC patient care in order to ensure building a successful RC infrastructure. Academic clinicians, basic scientist engineers, stem cell biologists, developmental biologists, and industrial liaisons also have been included in the proposed Tufts RC in order to ensure a successful outcome. This Stage 1 Planning Grant will set the stage for the 3-year Stage 2 Award that will be used to establish the Tufts Centralized DOCTRC RC, developing a robust infrastructure to deliver uniform, high-quality technical support and research capacities for preclinical studies. The Stage 2 period will also be used to organize, recruit and integrate several Interdisciplinary Translational Project (ITP) teams into the Tufts Centralized RC. Each of these ITP teams will have identified and developed a specific tissue engineering and regenerative medicine (TE/RM) approach for regeneration of a functional DOC tissue that synergizes with the expertise of one of the Tufts DOC-RC teams. Finally, we anticipate submitting a competitive Stage 3 Consortium Stage application, which will utilize the resources developed in Stage 2 to work with the DOC-RCs and the FDA to advance specific TE/RM clinical applications. The Stage 3 Consortium Stage will complete validation, manufacturing and preclinical testing of the most likely to succeed TE/RM products, and develop Investigational New Drugs/Investigational Devices (IND/IDs) for submission to FDA. The outcome of the DOCTRC-TE/RM will be products and associated protocols ready for initiation of Phase I clinical trials.

 描述（由应用程序提供）：此阶段1规划赠款将为集中式塔夫茨牙科，口腔和颅面组织再生财团（Doctrc）资源中心（RC）的集中式塔夫茨牙科，口头和颅面的整体愿景，路线图，组织结构和操作程序。在这项为期一年的1阶段赠款完成时，Tufts Doctrc组织者将制定详细的计划，以建立互动，跨学科的DOC-RC团队的生物学家，生物工程师，临床医生和其他技术专家。这项工作将由参与DOC患者护理的每天的执业临床医生驱动，以确保建立成功的RC基础设施。学术临床医生，基础科学工程师，干细胞生物学家， 开发人员生物学家和工业联络员也已包含在拟议的塔夫茨RC中，以确保成功的结果。这一第1阶段规划赠款将为3年阶段2奖奠定阶段，该奖项将用于建立塔夫茨集中式Doctrc RC，开发出强大的基础设施，以提供统一，高质量的技术支持和临床前研究的研究能力。第2阶段时期还将用于组织，招募和整合几个跨学科翻译项目（ITP）团队中的塔夫茨集中式RC。这些ITP团队中的每一个都将确定并开发了一种特定的组织工程和再生医学（TE/RM）方法，用于与塔夫茨DOC-RC团队的专家协同工作的功能性DOC组织再生。最后，我们预计将提交一个竞争激烈的第三阶段财团阶段应用程序，该阶段将利用第2阶段中开发的资源与DOC-RCS和FDA合作，以推进特定的TE/RM临床应用。第三阶段财团阶段将完成最有可能成功的TE/RM产品的验证，制造和临床前测试，并开发研究性新药/研究设备（IND/IDS）以提交FDA。 Doctrc-Te/RM的结果将是准备I期临床试验的产品和相关方案。