Establishing a Resource Center for Tissue Engineered Craniofacial Technologies

 描述(申请人提供)：组织工程疗法的需求越来越大，尤其是颅颌面部，因为它是身体暴露最严重的区域之一，造成显著的高伤害风险。此外，不幸的是，颅颌面部是许多肿瘤和其他实体的所在地，这些肿瘤和实体需要处理，需要结构的显著变形。这些问题反过来又可能导致审美和功能缺陷。面部作为人类形态中最明显的部分，在社会交往中起着重要的作用，当面部因损伤或消融手术而变形时，就会出现严重的心理社会问题。再生医学领域随着许多令人兴奋的技术而不断增长，但不幸的是，很少有技术成为临床疗法。这一规划拨款申请将实现行业教会我们的东西，即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商业流程。通过这项拨款申请，我们计划扩大匹兹堡大学现有的组织工程/再生医学(TE/RM)领域科学和翻译开发专业知识的广泛基础。通过麦高恩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，我们计划完成使命，催化、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来实现：具体目标1：正式确定资源中心的基础设施、流程和实施方法。这一目标将分为3个子目标：目标1A。使现行行业标准适应学术-行业模式。目标1B：加强我们的专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：执行行动计划，促进cGLP/cGMP活动提交FDA。我们悠久的组织工程历史，加上我们的成就和对转化TE/RM技术的热情，使我们成为成功实现NIDCR将DOCTRC过渡到FDA提交阶段的主要参与者之一。

 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.