The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to conventional untreated RBCs stored for 35 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
42
Each subject will receive one intravenous infusion of autologous radiolabeled S303 Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.
Each subject will receive one intravenous infusion of autologous radiolabeled Conventional, untreated Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.
Hoxworth Blood Center
Cincinnati, Ohio, United States
BloodCenter of Wisconsin Inc.
Milwaukee, Wisconsin, United States
Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days
24 hour post-infusion recovery of autologous RBCs stored for 35 days (assessed using the Food and Drug Administration (FDA)) criteria for evaluation of in vivo RBC studies)
Time frame: 70 Days
Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)
Incidence of antibody specific to S 303 treated RBCs
Time frame: 70 days
Secondary Safety: Incidence of adverse events
Incidence of adverse events
Time frame: 70 Days
Secondary Efficacy Endpoint
Mean lifespan of autologous red blood cells (RBCs)
Time frame: 70 days
Secondary Efficacy Endpoint:
Median lifespan (T50) of autologous red blood cells (RBCs)
Time frame: 70 days
Secondary Efficacy Endpoint
Area under the curve (AUC) derived from data points collected for the red blood cell (RBC) lifespan
Time frame: 70 days
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