Human Tissue Engineered Matrix Constructs for Repair

用于修复的人体组织工程基质构建体

• 批准号: 7156285
• 负责人: ANTHONY RATCLIFFE
• 金额: $ 80.6万
• 依托单位: SYNTHASOME, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7156285
• 关键词: dogs; extracellular matrix; human; human tissue; injury; model; tendons; tissue engineering

DESCRIPTION (provided by applicant): Surgical repair of rotator cuff injury is a common procedure, however structural failure of the surgical repair is a common complication of the surgery, and may be a frequent occurrence. There is therefore a recognized need to enhance the surgical repair of rotator cuff injuries. Recently, extracellular matrices have been used to aid surgical repair of connective tissues, although they have very modest mechanical properties and do not represent optimal designs of a product for their application. The objective of this program is to develop a product that has characteristics specifically designed to aid the surgical repair of rotator cuff injuries. A functional tissue engineering approach is being used to develop a device that will enhance the surgical repair of rotator cuff tendons. The device will be generated using the application of new technologies that have recently been developed at Synthasome, for which patent applications have been filed. The final product will be a device composed of a biomaterial with mechanical properties similar to native human rotator cuff tendon (designed to stabilize the repair site and confer mechanical functionality during the repair process), coated with a human extracellular matrix (to support in vivo biological repair). The overall long term hypothesis that this program will test is that a tissue engineered acellular construct composed of a functional scaffold and an extracellular matrix, designed to provide mechanical stability and functionality and support biologic repair, will enhance the quality of surgical repair for rotator cuff injury. The objectives of a previous Phase I application have been achieved. The objectives of this Phase II project are to determine the device effectiveness and safety in vivo (using a canine model of rotator cuff repair), and develop a human extracellular matrix-based repair product and test its safety in vivo (using a standardized biocompatibility model). Specific Aim 1. Determine effectiveness of the device in vivo, using a canine model of rotator cuff repair. Specific Aim 2. Prepare a human repair construct, and determine biocompatibility of the device. The successful outcome of these Aims will be the development of an acellular, human-based tissue engineered construct with the demonstrated ability to enhance the repair of rotator cuff injury, and with demonstrated safety. The successful outcome of this project will be the development of an acellular, human-based tissue engineered construct with the demonstrated safety and ability to enhance the repair of rotator cuff injury. The results obtained will provide the data necessary for a regulatory submission to the FDA to market the product.

描述（由申请人提供）： 肩袖损伤的手术修复是一种常见的手术，但是手术修复的结构性失败是手术的常见并发症，并且可能经常发生。因此，人们认识到需要加强肩袖损伤的手术修复。最近，细胞外基质已被用于辅助结缔组织的手术修复，尽管它们具有非常适度的机械性能并且并不代表其应用的产品的最佳设计。该计划的目标是开发一种具有专门设计用于帮助修复肩袖损伤的特性的产品。功能性组织工程方法被用来开发一种装置，该装置将增强肩袖肌腱的手术修复。该设备将使用 Synthasome 最近开发的新技术应用来生成，并已提交专利申请。最终产品将是一种由生物材料组成的装置，其机械性能类似于天然人类肩袖肌腱（旨在稳定修复部位并在修复过程中赋予机械功能），并涂有人类细胞外基质（以支持体内生物维修）。该计划将测试的总体长期假设是，由功能支架和细胞外基质组成的组织工程无细胞结构，旨在提供机械稳定性和功能并支持生物修复，将提高肩袖损伤的手术修复质量。之前第一阶段申请的目标已经实现。该二期项目的目标是确定装置的体内有效性和安全性（使用犬肩袖修复模型），开发基于人体细胞外基质的修复产品并测试其体内安全性（使用标准化生物相容性模型） ）。具体目标 1. 使用肩袖修复的犬模型确定装置在体内的有效性。具体目标 2. 制备人体修复结构，并确定设备的生物相容性。这些目标的成功结果将是开发一种无细胞的、基于人体的组织工程结构，该结构具有增强肩袖损伤修复的能力，并且具有安全性。该项目的成功成果将是开发一种无细胞的、基于人体的组织工程结构，其安全性和增强肩袖损伤修复能力的能力已得到证实。获得的结果将为向 FDA 提交监管申请以销售该产品提供必要的数据。