? 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. ? ?
