HARVESTING AUTOLOGOUS GROWTH FACTORS FOR WOUND HEALING

描述(由申请人提供)： 一种新的促进伤口愈合的临床方法涉及在各种外科和门诊情况下使用重组或自体生长因子来改善治疗结果。然而，目前可用的基于生长因子的伤口愈合疗法相对昂贵，而且使用起来往往很麻烦。申请者开发了一种简单而廉价的技术，消除了对笨重设备的需要。I期研究已经证明，使用一次性设备可以获得包含生长因子的高血小板产量，该设备允许受控地输送具有显著有丝分裂活性的血小板生长因子，从而加速细胞生长。在这项第二阶段研究中，申请人提议开展并完成一种方便且廉价的术中过程的商业化前调查，以从自体体内采集和浓缩含有生长因子的血小板，以促进伤口愈合。将使用申请人的方法对与从自体血液中获得浓缩血小板相关的关键参数进行优化和表征。将开发和测试简化申请者过程并使其自动化的原型设备套件。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、自动化的方式整合和执行血液生成过程。通过申请人的技术提取的血小板的体内伤口愈合活性将在软组织和硬组织动物模型中进行测试。皮肤创伤模型将被用来模拟软组织创伤，猪骨缺损(通过截骨)模型将被用来模拟硬组织创伤。自体血小板生长因子的有效性将在这些动物模型中使用不同的载体底物进行测试，如海藻酸盐、纤维蛋白、水凝胶和壳聚糖-磷酸钙海绵。这些研究将是商业化努力和临床研究的重要先驱，最终将测试通过血液生成技术获得的自体血小板生长因子产品的疗效。

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.