Improved understanding of the role of growth factors as biochemical mediators of wound healing has paved the way for a new family of bioactive therapeutic products to expedite wound healing. Delivery of growth factors (recombinant or as autologous platelets) has emerged as a possible commercial opportunity for improving the clinical outcomes of soft, bone, and connective tissue repair. However, wide acceptance of growth factors to accelerate wound healing has been hampered because current recombinant and autologous platelet growth factor-based products are prohibitively expensive and current methods for procurement of autologous platelets are cumbersome and time consuming. Moreover, none of the current platelet harvesting devices has FDA approved claims for wound healing. The applicants have developed a simple and inexpensive technique to rapidly obtain autologous platelet concentrate from blood (<10 min) without the need for expensive equipment. The process has been characterized and optimized to achieve high yields of platelets with normal growth factor content, and the safety and efficacy of the resulting platelet concentrate in accelerating cell proliferation in vitro and improved wound healing in animal models in vivo has been demonstrated. The objectives of this Phase II continuation application are to: (i) design and manufacture an automated device that is fully disposable to improve the robustness of platelet recovery and to further minimize operator involvement, and (ii) to establish clinical efficacy of the harvested platelet concentrate in promoting cutaneous wound healing. Product development activities will include computer aided design and manufacturing, rapid prototyping, molding, assembly, preclinical testing, and establishing a quality assurance program leading to Good Manufacturing Practices for limited production of the device. The clinical study will focus on treating acute skin wounds and venous ulcers with the obtained platelet concentrates using a protocol based on FDA guidance documents for wound healing studies. Results of this study using a convenient and affordable device could indicate, for the first time, the clinical utility of autologous platelet concentrates in accelerating cutaneous wound closure based on a prospective, randomized, controlled clinical trial. Successful outcome of this trial is expected to lead to the first autologous platelet concentrate with FDA approved wound healing claims, which could encourage widespread use of the applicants' device to augment wound healing. The affordability and convenience of the product being developed in this project will allow growth factor-mediated wound healing to reach diverse patient populations in a wide variety of situations from well-equipped operating rooms to minimally equipped remote battlefield medical units. ? ? ?
