Anaerobically stored red blood cells with extended shelf-life.

Period of Performance: 06/06/2007 - 08/05/2008

$133K

Phase 1 SBIR

Recipient Firm

NEW Health Sciences, Inc.
BETHESDA, MD 20817
Principal Investigator

Research Topics

Abstract

DESCRIPTION (provided by applicant): The long-term objective of this project is to develop a novel blood storage bag that will extend the shelf life of additive system red cell units, and at the same time, deliver red cells of higher efficacy for transfusion therapy. In this system, red cells are stored in a modified additive solution under oxygen- depleted conditions. The final product will have extended shelf-life (12 weeks or more) as well as higher efficacy compared to same-aged blood stored by conventional methods (more viable cells, higher oxygen delivery capacity immediately after transfusion and more deformable cells for better capillary perfusion). The new storage system will be readily accommodated by the current blood banking operation without incurring major alteration in procedures or equipments. In this Phase I proposal, a novel anaerobic storage system will be tested for its ability to extend shelf life by 50%(to 9 weeks) and to yield red cells with higher post-transfusion recovery compared to the conventional method (AS-1 additive system) after 6 weeks of storage. In a cross over clinical trial (8 volunteers), a unit of red cells will be collected and stored under anaerobic condition in an experimental additive solution (test) or in a conventional method (control). A small fraction of stored cells will be labeled and transfused back to the donor to assess the quality of the stored cells by measuring the 24 hr post- transfusion recovery and long-term survival. These measurements will be taken after 6 weeks of storage to assess whether the proposed system has higher recovery compared to the control. They will be also measured after 9 weeks for the test units to assess its ability to extend shelf life by 50%. Stored red cells with higher post-transfusion viability and oxygen delivery capacity will improve the efficacy of transfusion therapy and reduce associated side effects. Moreover, transfusion of such red cells will reduce the frequency- and time-averaged blood transfusion volume and total iron burden in subjects who require chronic transfusion (e.g., sickle cell disease or beta-thalassemia). Extended shelf-life will improve the logistics of general blood banking, alleviate the periodic blood shortages and enhance the utility of pre-operative autologous blood collection.