Cerus Corporation
This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC clearance, and/or evidence of hemolysis. Because the recovery and survival of fresh allogeneic INTERCEPT RBCs in patients with a diverse group of diseases is poorly characterized, a Control group of subjects without a history or evidence of antibodies to INTERCEPT RBCs may be evaluated as a comparator (Control group subjects may or may not have previously been transfused with INTERCEPT RBCs). The study will also compare and correlate results from anti-human globulin (AHG) crossmatch using INTERCEPT RBCs prepared for transfusion, with results from indirect antiglobulin testing (IAT) with S 303 treated reagent RBCs (i.e., INTERCEPT RBC screening assay, as used in previous studies) to assess the utility of the AHG crossmatch to define the compatibility of transfused INTERCEPT RBCs
This is a prospective, open-label, controlled Phase 2 study. Consented subjects will be screened for currently detectable or previously documented allogeneic, autologous, and INTERCEPT RBC-specific antibodies, assigned to a study arm, then receive a small volume transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs under careful clinical oversight for adverse events including evidence of hemolysis. Subjects will have blood samples drawn pre-transfusion and over 90 days after transfusion (Days 0, 1, 7, 14, 30, 60, and 90) to detect evidence of primary or secondary immune responses to I…
Inclusion Criteria: * Age ≥4 years in children who meet the requirement of US Code of Federal Regulation (CFR) Title 21, §50.53 as determined by the local Institutional Review Board (IRB). * Control subjects shall have no current or previously documented antibodies to INTERCEPT RBC. * Test subjects shall have current or previously documented natural or treatment-emergent antibodies to INTERCEPT RBCs. * History of prior transfusion with allogeneic blood products (INTERCEPT or non-INTERCEPT treated). * \>120 days from the subjects most recent exposure to Study RBCs (pathogen reduced or non-path…
Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or \~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.
Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or \~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.