About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- INTERCEPT Blood System for RBCs
- Infusion of autologous radiolabeled RBCs