HARVESTING AUTOLOGOUS GROWTH FACTORS FOR WOUND HEALING

收获自体生长因子以促进伤口愈合

• 批准号: 6645197
• 负责人: Don B. Olsen
• 金额: $ 32.26万
• 依托单位: HEMOGENESIS, LLC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-01 至 2005-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6645197
• 关键词: biotherapeutic agent; cell sorting; centrifugation; clinical research; cytotoxicity; drug design /synthesis /production; growth factor; human tissue; platelets; protein purification; surgery material /equipment; swine; technology /technique development; tissue /cell preparation; wound healing

DESCRIPTION (provided by applicant): An emerging clinical approach for augmenting wound healing involves the use of recombinant or autologous growth factors for improved therapeutic outcomes in various surgical and outpatient situations. However, currently available growth factor-based wound healing therapies are relatively expensive and often cumbersome to use. The applicants have developed a simple and inexpensive technique obviates the need for cumbersome equipment. Phase I studies have demonstrated that high platelet yields with included growth factors can be obtained using a disposable device that allows controlled delivery of platelet growth factors with significant mitogenic activity resulting accelerated cell growth. In this Phase II study, the applicants proposes to undertake and complete pre-commercialization investigations of a convenient and inexpensive intraoperative process to harvest and concentrate platelets with contained growth factors from autologous for enhancing wound healing. Optimization and characterization of key parameters associated with obtaining platelet concentrates from autologous blood using the applicants' method will be conducted. A prototype device-kit that simplifies and automates the applicants' process will be developed and tested. The prototype will consist of a base unit and disposable components that will integrate and execute the Hemogenesis process in a simple, and automated fashion. The in-vivo wound healing activity of platelets retrieved by the applicants' technique will be tested in soft and hard tissue animal models. A procine skin wound model will be utilized to simulate soft-tissue wounds, and a porcine bone defect (by osteotomy) model will be used to simulate hard tissue wounds. The efficacy of autlogous platelet growth factors will be tested in these animal models using various carrier substrates such as alginate, fibrin, hydrogel, and chitosan-calcium phosphate sponge. These studies will be an important precursor to commercialization efforts and clinical investigations that will eventually test the efficacy of the autologous platelet growth factor product that is obtained by the Hemogenesis technique.

描述（由申请人提供）： 一种增加伤口愈合的新兴临床方法涉及使用重组或自体生长因子，以改善各种手术和门诊患者的治疗结果。但是，目前可用的基于生长因子的伤口愈合疗法相对昂贵，并且通常很麻烦。申请人开发了一种简单且廉价的技术，可以避免对繁琐的设备的需求。第一阶段的研究表明，可以使用一次性装置获得具有包括生长因子的高血小板产量，该装置允许控制血小板生长因子具有显着有丝分裂活性的血小板生长因子，从而加速了细胞生长。在这项II阶段的研究中，申请人提议对方便且廉价的术中过程进行和完整的商业前研究，以收获和浓缩血小板，其中包含自体的生长因子，以增强伤口愈合。将使用申请人的方法进行与从自体血中获得血小板浓缩物相关的关键参数的优化和表征。将开发和测试简化和自动化申请人过程的原型设备套件。该原型将由基本单元和一次性组件组成，这些组件将以简单且自动化的方式整合和执行血液发生过程。申请人技术检索到的血小板的体内伤口愈合活性将在软组织动物模型中进行测试。 Procine皮肤伤口模型将用于模拟软组织伤口，并将使用猪骨缺损（通过截骨切开术）模拟硬组织伤口。在这些动物模型中，将使用各种载体底物（例如藻酸盐，纤维蛋白，水凝胶和壳聚糖 - 磷酸盐海绵）测试肾脏血小板生长因子的功效。这些研究将是商业化工作和临床研究的重要先驱，最终将测试由血小板技术获得的自体血小板生长因子产物的功效。