Red Blood Cell Survival in Sickle Cell Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 29, 2021

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Sickle Cell Disease
Interventions
DRUG

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On the day of transfusion, a 20 mL aliquot will be sterilely withdrawn from each RBC unit, washed and labeled with sulfo-NHS-biotin for 30 minutes, washed to stop the labeling reaction, then resuspended in plasma to a hematocrit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.

DEVICE

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.

Trial Locations (3)

30303

Hughes Spalding Children's Hospital, Atlanta

30322

Childrens Healthcare of Atlanta, Atlanta

Grady Health System, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Cerus Corporation

INDUSTRY

lead

Marianne Yee

OTHER

NCT04426591 - Red Blood Cell Survival in Sickle Cell Disease | Biotech Hunter | Biotech Hunter