Randomized Study to Evaluate Recovery and Lifespan of Autologous INTERCEPT-Treated Red Blood Cells Stored for 35 Days Compared to Untreated RBCs

What this Trial Is About

Researchers are evaluating the recovery and lifespan of autologous red blood cells RBCs treated with the INTERCEPT Blood System for RBCs with AS-1 in healthy adult subjects. This Phase 2, randomized, controlled, single-blind study compares 35-day-old INTERCEPT-treated RBCs to untreated RBCs stored for the same period. The objective is to measure the 24-hour post-infusion recovery and the lifespan of these RBCs to assess their viability after storage and treatment. Participants will donate a unit of whole blood that is processed to produce RBC components treated either with the INTERCEPT Blood System Test group or untreated as per standard procedures Control group. These RBCs are stored at 1C to 6C for 35 days. On Day 35, subjects receive a single intravenous infusion of approximately 10 to 30 mL of their own radiolabeled RBCs. The study involves infusions of 51Cr-labeled RBCs from treated or untreated blood, alongside 99mTc-labeled fresh RBCs, to measure recovery and blood volume. Participants will provide multiple blood samples at various times after infusion to measure RBC recovery, volume, and lifespan up to 35 days post-infusion. Safety is monitored for 24 hours after blood donation and infusion, focusing on adverse events and transfusion reactions. Additional laboratory testing of RBC samples at different stages will evaluate in vitro RBC properties. The total study duration and detailed monitoring ensure comprehensive evaluation of RBC viability and safety.

A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1