I-Corps: Autologous Thrombin Device

University Enterprises, Incorporated, Sacramento CA

Investigators

Abstract

Thrombin is the blood protein that is capable of stopping bleeding (hemostasis) and activating platelets to release growth factors that promote bone growth and healing. Current thrombin products all have one or more safety issues, including antigenicity, risk of transmitting infectious diseases, and cytotoxicity. The existing market for thrombin products worldwide is $1.4 billion annually. The team has developed a technology that provides surgeons the means to prepare thrombin from the patient's own blood without including cytotoxic chemical stabilizers. The proposed innovation enables a new thrombin therapeutic to be generated not only for hemostasis applications, but also for regenerative medicine applications as cell delivery scaffolds. This team is the first to create autologous thrombin that poses no risk of an immune response, transmitting an infectious disease, or causing a cytotoxic reaction at the site of placement. Currently, there are four thrombin products on the market: 1) Thrombin-JMI from King Pharmaceuticals, Inc., which is derived from cow's blood; 2) EVITHROM from Ethicon, Inc., a Johnson & Johnson Company, which is derived from pooled plasma from 60,000 human donors; 3) RECOTHROM from ZymoGenetics, Inc. which is rDNA derived from cultured mammalian cells; and 4) CLOTALYST from Biomet, Inc., which is autologous thrombin containing 20% ethanol added as a chemical stabilizer. The team has validated the chemistry for preparing thrombin from either whole blood or plasma, devised a practical (alpha prototype) Autologous Thrombin Device that is assembled from commercially available materials suitable for human use to practice the chemistry at the point of care, written an 'instructions for use' document, generated a comprehensive Product Requirements Document, and has filed provisional and utility patent applications.