SymClot: synthetic platelet mimetic particles for augmenting hemostasis in patients requiring extracorporeal support

This proposal focuses on the evaluation of SymClot, a synthetic platelet therapy for use in treating ECMO-associated hemorrhage. We propose to optimize SymClot formulation for reliable and efficient lyophilization and reconstitution facilitating transport to and usage in military hospitals and to evaluate its ability to mitigate bleeding in a preclinical sheep ECMO model. SelSym Biotech has obtained extensive in vitro and preclinical data establishing SymClot efficacy in reducing bleeding in wildtype models of trauma and Dr. Enkhbaatar at UTMB has an established ovine smoke inhalation ECMO model to allow the study of bleeding event in ECMO patients. Dr. Enkhbaatar will serve as PI of the UTMB subaward and will conduct preclinical work in the ECMO model using SymClot particles provided by SelSym Biotech. The proposed structure of the tasks in this proposal for UTMB are as follows: Dr. Enkhbaatar's lab will provide SelSym Biotech with ovine blood from ECMO patients for in vitro analysis of SymClot efficacy in improving clot stability and strength in this plasma type. Dr. Enkhbaatar’s lab will also perform preclinical work utilizing their ovine smoke inhalation EMCO model to assess SelSym’s synthetic platelet technology in reducing bleeding in ECMO patients. This will be determined via evaluation of clotting parameter throughout the study period and via histological analysis of tissues particularly lung tissues obtained at the conclusion of the study. The data acquisition and reporting will be done as per DOD guidelines. It is hypothesized that the proposed work would allow translation of innovative PLP to develop a novel hemostatic agent for use in the clinically unmet area of mitigating adverse bleeding events for patients undergoing extracorporeal life support.