Status:
COMPLETED
Red Blood Cell Survival in Sickle Cell Disease
Lead Sponsor:
Marianne Yee
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Cerus Corporation
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
Brief Summary
This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease (SCD) receivi...
Detailed Description
Sickle cell disease (SCD) carries significant morbidity as a result of red blood cell (RBC) sickling and hemolysis. Stroke is one of the most devastating sequelae of SCD. Chronic transfusion therapy (...
Eligibility Criteria
Inclusion
- Hemoglobinopathy:
- Any sickle cell disease genotype, or
- Transfusion-dependent thalassemia (TDT)
- Receiving CTT for ≥3 months prior to enrollment.
- For participants with past BioRBC transfusion exposure, BioRBC antibody screens must have been conducted through at least 6 months post exposure, with negative results.
Exclusion
- Anticipated cessation of CTT in the next ≤2 months
- Ongoing consumption of biotin or raw egg dietary supplements
- Antibody specific of INTERCEPT RBCs at baseline (for subjects consenting to the optional arm)
- BioRBC-specific antibodies ever detected in the past, or detected on post-enrollment screening prior to first infusion of Bio-RBC.
Key Trial Info
Start Date :
October 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04426591
Start Date
October 29 2021
End Date
April 30 2025
Last Update
June 8 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hughes Spalding Children's Hospital
Atlanta, Georgia, United States, 30303
2
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
3
Grady Health System
Atlanta, Georgia, United States, 30322