Feasibility-Phase Development of a Next-Generation (Reduced Processing Time) Pathogen Reduction and Blood Safety System
Abstract
This program of work directly addresses the Fiscal Year 2016 Peer Reviewed Medical Research Program Area of Encouragement under the Pathogen Inactivated Dried Plasma Topic Area that states: ?Development of a next-generation pathogen reduction device with increased throughput for donor center production of whole blood, platelets, and plasma in support of contingency/combat operations.? Blood is a critical resource for the care of soldiers injured in battle, but there are risks associated with transfusion, including the risk of transfusion-transmitted infections from pathogens such as viruses, bacteria, and parasites, and the risk of immunologic complications due to the introduction of foreign white blood cells (WBC). Pathogen reduction is a proactive strategy by which these risks can be reduced in blood products intended for transfusion. The Mirasol System for Whole Blood is a pathogen reduction device that has been developed with US Department of Defense (DoD) support for implementation in combat zone mobile medical facilities. Mirasol Pathogen Reduction Technology is a Program of Record for the US DoD that is moving forward with a pivotal clinical trial to support US Food and Drug Administration approval for red blood cells derived from Mirasol-treated whole blood (WB). The Mirasol system utilizes a non-toxic photosensitizer, riboflavin (vitamin B2), and ultraviolet (UV) light to inflict irreparable damage to the nucleic acids found in pathogens and donor WBCs. The first-generation system has been implemented as a transportable device, suitable for treatment of emergency fresh whole blood donations collected by mobile military units for resuscitation of severely injured soldiers in theater. The size, weight, and other operational constraints supporting transportability drove compromises in treatment capacity and throughput. The proposed next-generation device will maintain the core riboflavin + UV light Mirasol pathogen reduction technology while exploring the optimization of system throughput to better suit the production needs of military and civilian blood centers. During this feasibility phase project, the applicant proposes to integrate technical improvements that have been demonstrated on a standalone basis into a prototype batch processing module that can be expanded or replicated to produce a higher throughput pathogen reduction system. This design concept will address not only the device hardware and software but also disposables, with the goal of producing a lower-cost, easier-to-use kit for the treatment of WB. A parallel effort will focus upon user requirements research at both military and civilian blood centers around the world. Taken together, these efforts will answer the question, ?Can a commercially viable, higher-throughput pathogen reduction device be designed for the treatment of WB?? If successful, the proposed program of work will define a pathway for widely available, safer blood products for treatment of both military and civilian patient populations.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Aug 07, 2017
- Source ID
- W81XWH1710381
Entities
People
- Heather Pidcoke
Organizations
- Terumo BCT (United States)
- United States Army