The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.
Age ≥18 years
Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.
Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.
History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)
Positive DAT or IAT at study entry
Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
Parallel
INTERCEPT Blood System for RBCs
DeviceRBCs treated with the INTERCEPT Blood System for RBCs
Infusion of autologous radiolabeled RBCs
Other interventionSubject will receive a single intravenous infusion of approximately 10 to 30 mL of autologous Day 35 51Cr radiolabeled RBCs and fresh 99mTc RBCs.
The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion
The 24-hour recovery will be calculated using the subject's blood volume derived from infusion of 99mTc-labeled fresh RBCs.
. The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion
The 24-hour recovery will be calculated using the subject's blood volume derived the subject's height and weight.
. The number of days 51Cr-labeled Test/INTERCEPT or Control RBCs remain in circulation up to post-infusion
The value will be derived by measurement of detectable 51Cr- labeled RBC with time
Hemolysis (<1%)
Proportion of RBC component hemolysis on Day 35 (\<1%).
Adverse Events
Incidence of treatment emergent adverse events possibly, probably, or definitely related to the study RBCs over the course of the study.
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