HARVESTING AUTOLOGOUS GROWTH FACTORS FOR WOUND HEALING

描述（由申请人提供）： 一种用于增强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在各种手术和门诊情况下改善治疗结果。然而，目前可用的基于生长因子的伤口愈合疗法相对昂贵，并且使用起来通常很麻烦。申请人已经开发了一种简单且廉价的技术，避免了对笨重设备的需要。I期研究已经证明，使用一次性装置可以获得包含生长因子的高血小板产量，所述一次性装置允许具有显著促有丝分裂活性的血小板生长因子的受控递送，从而导致加速的细胞生长。在该II期研究中，申请人提出进行并完成对方便且廉价的术中过程的商业化前研究，以从自体中收获并浓缩含有生长因子的血小板，以促进伤口愈合。将对使用申请人的方法从自体血液中获得血小板浓缩物相关的关键参数进行优化和表征。将开发和测试一个简化和自动化申请人程序的原型设备包。原型将由一个基本单元和一次性组件组成，这些组件将以简单的自动化方式集成和执行造血过程。将在软组织和硬组织动物模型中测试通过申请人的技术回收的血小板的体内伤口愈合活性。猪皮肤伤口模型将用于模拟软组织伤口，猪骨缺损（截骨术）模型将用于模拟硬组织伤口。将在这些动物模型中使用各种载体基质（如藻酸盐、纤维蛋白、水凝胶和壳聚糖-磷酸钙海绵）测试自体血小板生长因子的功效。这些研究将是商业化努力和临床研究的重要先驱，最终将测试通过造血技术获得的自体血小板生长因子产品的有效性。

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.