SBIR-STTR Award

The main goal of this proposal is to develop stabilized freeze-dried Yucatan pig platelets that will retain the majority of platelet biological properties, but can be stored in the dry state for years. These platelets will be incorporated into a hemostatic dressing that will control bleeding in the Yucatan pig wound and bone healing model. This proposal is based on the extensive amount of work already performed at Adlyfe, where stored human freeze-drying trehelose-loaded platelets, upon reconstitution with water, demonstrated normal response to physiological agonists as well as able to release growth factors in controlled spatial and temporal manner. In phase I, key structural and functional parameters will be measured in vitro to determine the efficacy of the freeze-dried Yucatan pig platelets as hemostatic agent. These studies will be critical toward the pre-clinical and clinical development of this important hemostat therapeutic proposed for Phase II

Blood loss due to uncontrolled hemorrhage is a major contribution to at least 90% of the combat death before reaching the field hospital. The ability to control heavy bleeding in the injured soldier is critical and will vastly improve the survival outcome in the theater. Furthermore, complications from uncontrolled bleeding in the microvasculature contribute significantly to increased morbidity. Finally, disruption of the vasculature during trauma can limit healing and soft tissue repair and regenerative phases once bleeding has subsided. Our goal is to address these critical aspects of combat casualty care, providing first echelon care that will have significant impact on acute events as well as improved outcome late into the time course of treatment and recovery. Our approach to developing next generation hemostatic products for combat casualty care is to exploit the natural properties of platelets which contain both hemostatic and healing properties.

Keywords:
FREEZE-DRIED PLATELETS, HEMOSTASIS, WOUND HEALING, FDP-BANDAGES, INTERNAL AND EXTERNAL ANIMAL BLEEDING MODELS, ACCELERATED CLOT TIMES, TREHALOSE STABI