COLLAGEN BASED LIGAMENT TEMPLATE FOR ACL RECONSTRUCTION

描述（改编自申请人的摘要）：总体目标 这项研究的一个重要部分是设计、开发和体内测试一种 基于I型胶原蛋白的工程化韧带模板，以支持 膝关节前交叉韧带（ACL）的再生。 在第一阶段，我们已经实现了大部分目标。 具体而言，我们设计并开发了一种挤出设备， 胶原纤维的挤出;我们已经测试了挤出 生产均匀和可重复的长丝的变量：我们 研究了各种交联剂的毒性， 各种交联材料的细胞相容性，并定义了 用于交联长丝的最合适的交联剂;我们有 定义了韧带的总体机械强度要求 用于犬类植入的模板;我们已经植入了原型 8个犬膝关节进行ACL重建。 在第二阶段，我们会继续改善设计， 制造程序，并评估安全性和有效性参数 胶原韧带模板。 我们将进行一次大型动物实验 对最佳定义原型的研究，以评估长期效果 通过吸收-再生-重塑-成熟 第二阶段研究的成功结果 将可能导致临床试验和商业化的 产品 仅在美国，每年就有近110，000例ACL损伤， 三分之一的伤者需要修复和重建。 AC：重建通常通过自体移植（骨-髌骨）进行 腱-骨）。 除了造成第二处损伤外， 自体移植通常导致疼痛和股四头肌力量丧失 并且需要延长康复时间。 没有理想的方法 确保膝盖恢复正常功能 拟议商业应用：不可用

DESCRIPTION (Adapted from the applicant's abstract): The overall goal of this research is the design, development and in vivo testing of an engineering type I collagen based ligament template to support the regeneration of the anterior cruciate ligament (ACL) of the knee joint. In the Phase I period, we have accomplished most of the objectives. Specifically, we have designed and developed an extrusion apparatus for the extrusion of collagen filaments; we have tested the extrusion variables for the production of uniform and reproducible filaments: we have studied various crosslinking agents for the toxicity and cytocompatiblity of the various crosslinked materials and defined the most suitable crosslinking agent for crosslinking the filaments; we have defined the overall mechanical strength requirement of the ligament template for canine implantation; and we have implanted the prototypes into eight canin knee joints for ACL reconstruction. During the Phase II, we will continue to improve the design and fabrication procedures and evaluate the safety and efficacy parameters of the collagen ligament template. We will conduct a large scale animal study on the best-defined prototype to evaluate the longer term effects of the implant through the resorption-regeneration-remodeling-maturation phase of the implant The successful results of this Phase II research will likely lead to a clinica trial and commercialization of the product. Nearly 110,000 ACL injuries per year in the U.S. alone and greater than one-third of the injured patients require repair and reconstruction. AC: reconstruction is generally performed by autografting (bone-patellar tendon-bone). In addition to the creation of a second injury site, autograftin often results in pain and strength loss in the quadriceps and requires extende rehabilitation times. There is no ideal method that ensures the restoration of a normal functioning knee. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE