DirectlyTransfusable Cryopreserved Red Blood Cells

This program is designed to establish the feasibility of developing a directly transfusable cryopreserved Red Blood cell (RBC) product. The approach of Lifecell's program is to utilize oxidative control and specific biocompatible water-structuring molecules to induce the formulation of non-damaging vitreous ice when frozen. These concepts will reduce the requirement for non-specific cryoprotection, thereby allowing the replacement of glycerol with ultimate transfusable cryoprotectants at low concentration. The resulting RBC product will be directly transfusable following thaw. Eliminating the necessary post-thaw wash protocol provides significant benefits over any preservation technologies that are not directly transfusable. These benefits include decreased cost, immediate availability, improved transportability and extend post-thaw storage time. The development of a simple, directly-transfusable RBC product will represent an important contribution to solving the critical blood banking problems associated with delivering safe and effective blood transfusions in variety of medical situations, both civilian and military. Successful development of this product will deliver a cryopreserved RBC having the following properties: 1. Logistically simple processing which integrates standard blood banking methods 2. Direct transfusion following storage, requiring no post-thaw wash 3. Non-toxic components, allowing for direct transfusidn 4. High recovery of cell number with normal circulatory half-life, efficient oxygen delivery and low hemolysis Successful completion of this RBC program (following Phase II and III development) will provide a means for cost-effective and convenient cryopreservation of RBC. The final RBC product, being directly-transfusable without cryoprotectant removal, will solve a major problem in civilian and military blood banking.