Freeze-Dried Human Red Blood Cells.
Abstract
A preliminary clinical evaluation of in vivo circulation of autologous, lyophilized and reconstituted human red blood cells was undertaken to establish a baseline level of in vivo performance of lyophilized red blood cells from both human volunteers and cynomolgus monkeys. The cell survival results demonstrated that reconstituted, lyophilized red cells remained in circulation in vivo for the same period as normal non-lyophilized red blood cells. Since our last progress report we have obtained additional in vivo survival data from a total of four healthy volunteers. The design of the clinical study protocol followed accepted procedures for red cell in vivo survival studies. In all of the four volunteers, no changes in vital signs occurred after an infusion os a small dose of the autologous lyophilized red blood cells and no associated adverse side effects were observed during the study and through the final follow-up examination conducted one week post infusion. In all four volunteers, peripheral blood samples were collected in citrate-phosphate-dextrose and adenine-1 (CPDA-1) for up to 6 days post infusion to measure the level of circulating chromium labeled red cells and to allow accurate estimation of the circulating half lives of the cells. Urine sample collection was also carried out during the first 24 hours post infusion for measurement of the levels of chromium clearance by the kidneys. Each volunteer was subjected to gamma imaging and external probe counts over the heart, spleen and liver at 4 hours and 24 hours post-infusion to determine the organ distribution of the radiolabeled reconstituted red blood cells.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 15, 1992
- Accession Number
- ADA253295