VIRALLY INACTIVATED HUMAN RED CELLS FOR TRANSFUSION

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The long-term goal is to increase the safety of red blood cell transfusions by reducing the possibility of blood-borne virus infections. In the United States alone, there are over 12,000,000 red blood cell transfusions annually and there is no virus inactivation procedure available to decontaminate them. Thus, an effective virus decontamination procedure would address a significant unmet health need. The INACTINE TM virus inactivation technology is currently in Phase 1 Clinical Trials. This proposal describes steps to develop this technology further toward a practical commercial procedure for decontaminating human red blood cells for transfusion. These studies include: 1 - Virus validation studies to support a pivotal clinical trial and pre- product license application; 2. Testing the sensitivity of a panel of potential bacterial contaminants to the treatment; 3. Design and manufacture of the disposable parts of the inactivation apparatus; 4. Studies of treated red blood cells in animals to confirm lack of neoantigenicity; 5. Additional toxicology studies to confirm the safety of treated red blood cells. The results of these studies will set the stage for pivotal clinical trials to be carried out during the five year time-frame of this proposal.