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（由适用提供）：对组织工程疗法的需求不断增长，尤其是针对颅面上的毛骨子，因为它是人体最暴露的区域之一，造成了严重的高伤害风险。此外，不幸的是，颅颌面区域是许多肿瘤和其他需要严重变形结构的实体的家园。这些问题反过来可能引起美学和功能性不足。作为人类形式中最明显的部分，面部发挥了重要的作用，n社会互动，当因伤害或消融手术后变形时，就会出现严重的心理社会问题。通过许多令人兴奋的技术，再生医学领域一直在增长，但不幸的是，只有很少的技术成为临床疗法。该计划赠款应用程序将实施行业教给我们的，即获得监管批准的最成功途径是在结构化的环境中建立完整性科学和业务流程。通过此赠款，我们计划增强匹兹堡大学提供的组织工程/再生医学（TE/RM）领域的科学和翻译发展专业知识的广泛基础。 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, nurse 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.这将通过以下两个特定目的来实现：特定目标1：正式化资源中心的基础架构，过程和实施方法。这个目标将分为3个子目标：目标1A。将当前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合作伙伴关系网络。目标1C：进一步开发我们的验证和GLP/质量控制评估。具体目标2：实施行动计划，以支持FDA提交的CGLP/CGMP活动。我们长期存在的组织工程历史，加上我们的成就和对翻译TE/RM技术的热情，将我们定位为成功实现NIDCR将Doctrc转变为FDA提交阶段的目标的主要参与者之一。