22
Participants
Start Date
October 29, 2021
Primary Completion Date
April 30, 2025
Study Completion Date
April 30, 2025
Biotin Labeled Red Blood Cells
On the day of transfusion, a 20 mL aliquot will be sterilely withdrawn from each RBC unit, washed and labeled with sulfo-NHS-biotin for 30 minutes, washed to stop the labeling reaction, then resuspended in plasma to a hematocrit of \~60%. The biotin-labeled RBC (BioRBC) will be transfused along with the remainder of the RBC unit (unlabeled volume). Standard blood bank and CTT protocols and minor antigen matching for SCD patients will be followed. Exact transfusion volume will be determined based on pre-transfusion hemoglobin (Hb), sickle cell hemoglobin (HbS), and body weight, per clinical protocol.
INTERCEPT Blood System
In addition to the blood drawn for the main study, individuals participating in this optional intervention will have additional tubes of peripheral venous blood will be drawn for evaluating treatment-emergent antibodies specific to INTERCEPT RBCs and acridine surface label monitoring. Tests for treatment-emergent antibodies specific to INTERCEPT RBCs will be performed according to procedures developed by Cerus Corporation.
Hughes Spalding Children's Hospital, Atlanta
Childrens Healthcare of Atlanta, Atlanta
Grady Health System, Atlanta
Collaborators (1)
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Cerus Corporation
INDUSTRY
Marianne Yee
OTHER