Fibrin sealant, a bioadhesive prepared from the coagulation proteins fibrinogen, factor XIII and thrombin, has been used extensively in surgery for the control of bleeding, gluing tissues and enhancing wound repair. Mixing and delivery of the major components, fibrinogen and thrombin, is currently achieved using two syringes or spray containers dispensed alternately or simultaneously to deliver fibrin sealant onto the wound site. These systems of delivery are unsatisfactory due to inadequate mixing of the solutions and inconsistent clot formation. A chamber can be attached to the syringes to facilitate mixing, but clogging occurs and frequent replacement of the needle, chamber and syringes are required. The long-term objective of the project has been to provide the medical community with a safe, easy-to-use alternative for promoting wound repair. Under a SBIR Phase I grant, a unique fibrin sealant formulation (patent pending) was developed for the mixing and delivery of fibrin sealant in a single syringe or container system, which results in the formation of a reproducible, strong clot.
Specific aims for Phase II include 1) develop viral inactivation processes for components derived from human plasma to minimize the transmission of infectious agents; 2) equip a pilot facility and scale up production of all components for preclinical and clinical studies; and 3) evaluate the formulation in preclinical trials.
