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Research Progress Report Submitted to the U.S. Naval Medical R&D Command

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The Basic Research section of this report outlines our progress in studying the total cation content and osmotic stability in saline of lyophilized reconstituted human red cells. Using stractan density gradients, we have identified fractions of recovered cells that exhibit improved osmotic stability and cation levels over our earlier formulations. The Clinical Research section outlines our recent low dose, autologous safety tests using lyophilized reconstituted red cells in normal adult male volunteers. Although we knew that the average in vitro osmotic stability of lyophilized human red cells in saline was lower than fresh red cells, we expected to observe a more stable sub- population of perhaps 10-20 of the injected dose circulating in vivo. The results of the initial two clinical studies indicate that fewer cells 2-4 appear to survive the initial few hours post-infusion. These results, confirmed by whole body radiation scans of the second volunteer, suggest that initial intravascular lysis is followed by splenic sequestration of the remaining intact cells and removal of free hemoglobin in the liver. As described in the Basic Research section, we have identified conditions that yield cells with significantly higher osmotic stability than were available for the first clinical studies. TTL

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  • Medicine and Medical Research

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