Establishing a Resource Center for Tissue Engineered Craniofacial Technologies

建立组织工程颅面技术资源中心

• 批准号: 9000902
• 负责人: ALBERT D DONNENBERG
• 金额: $ 19.25万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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/9000902
• 关键词: Achievement; Animal Model; Applications Grants; Area; Biocompatible Materials; Businesses; Cephalic; Clinical; Clinical Research; Clinical Sciences; Consultations; Cyclic GMP; Dental; Development; Documentation; Educational process of instructing; Engineering; Environment; Esthetics; Evaluation; Face; Foundations; Funding; Goals; Gold; Grant; Guidelines; Hematopoietic stem cells; Home environment; Human; In Vitro; Industry; Injury; Institutes; Laboratories; Learning; Medical Device; Medical center; Methods; Mission; Modeling; Monitor; National Institute of Dental and Craniofacial Research; Natural regeneration; Operative Surgical Procedures; Oral; Phase; Play; Positioning Attribute; Procedures; Process; Protocols documentation; Quality Control; Recording of previous events; Regenerative Medicine; Research Infrastructure; Research Personnel; Resources; Risk; Role; Side; Social Interaction; Staging; Structure; Technology; Technology Assessment; Therapeutic; Tissue Engineering; Tissues; Training; Translating; Translational Research; Translations; Universities; Validation; craniofacial; craniomaxillofacial; high risk; in vivo; innovation; member; new technology; preclinical study; programs; prototype; public health relevance; quality assurance; research study; social; sound; success; tissue regeneration; tumor

 DESCRIPTION (provided by applicant): There is a growing demand for tissue engineered therapies especially for the craniomaxillofacial since it is one of the most exposed areas of the body creating significant high risk of injuries. Additionally, the craniomaxillofacial region is unfortunately home to a host of tumors and other entities that require management requiring significant deformation of the structures. These issues in turn potentially cause aesthetic and functional deficits. As the most visible part of the human form, the face plays a significant role n social interaction and when deformed by injury or after ablative surgery, serious psycho-social issues arise. The field of regenerative medicine has been growing with many exciting technologies, but unfortunately only few became clinical therapies. This planning grant application will implement what industry taught us that the most successful path to achieve regulatory approval is to establish complementary scientific and business processes within a structured environment. With this grant application, we plan to augment the existing extensive foundation of scientific and translational development expertise in the tissue engineering/regenerative medicine (TE/RM) field available at the University of Pittsburgh. Through the robust and coordinated infrastructure of the McGowan Institute for Regenerative Medicine and its Center for Craniofacial Regeneration, we plan to fulfill the mission to catalyze, nurture and expedite the advancement of the most promising technologies in TE/RM to safely and effectively regenerate, reconstruct and restore dental, oral and craniofacial tissue and function. This will be achieved through the following two specific aims: Specific Aim 1: Formalize Resource Center's infrastructure, processes and methods for implementation. This aim will be divided in 3 sub aims: Aim 1A. Adapt current industry standard to academic- industry model. Aim 1B: Strengthen our Network of subject matter experts and partnerships. Aim 1C: Further develop our validation and GLP/quality control assessment. Specific Aim 2: Implement action plans to facilitate cGLP/cGMP activities for FDA submission. Our long standing tissue engineering history combined with our achievement and our passion to translate TE/RM technologies positions us to be one of the major players to successfully fulfill NIDCR's goals of transitioning DOCTRC to FDA submission stage.

 描述（由申请人提供）：对组织工程治疗的需求日益增长，尤其是颅颌面，因为它是身体最暴露的区域之一，造成显著的高损伤风险。此外，颅颌面区域不幸地是许多肿瘤和其他实体的家园，这些肿瘤和其他实体需要管理，需要结构的显著变形。这些问题反过来又可能导致美学和功能缺陷。作为人类形体中最明显的部分，面部在社会交往中起着重要的作用，当因受伤或消融手术而变形时，会出现严重的心理社会问题。再生医学领域一直在发展许多令人兴奋的技术，但不幸的是，只有少数成为临床治疗。这项规划补助金申请将实施行业告诉我们的，实现监管批准的最成功途径是在结构化环境中建立互补的科学和业务流程。有了这项资助申请，我们计划扩大匹兹堡大学现有的组织工程/再生医学（TE/RM）领域的科学和转化发展专业知识的广泛基础。通过McGowan再生医学研究所及其颅面再生中心强大而协调的基础设施，我们计划履行使命，促进，培育和加快TE/RM中最有前途的技术的进步，以安全有效地再生，重建和恢复牙齿，口腔和颅面组织和功能。这将通过以下两个具体目标实现：具体目标1：规范资源中心的基础设施、流程和实施方法。这一目标将分为三个子目标：目标1A。使当前的行业标准适应学术-行业模型。目标1B：加强我们的主题专家和伙伴关系网络。目标1C：进一步发展我们的验证和GLP/质量控制评估。具体目标2：实施行动计划，以促进向FDA提交的cGLP/cGMP活动。我们悠久的组织工程历史，加上我们的成就和我们对TE/RM技术转化的热情，使我们成为成功实现NIDCR将DOCTRC过渡到FDA提交阶段的目标的主要参与者之一。