At a glance
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Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
In Brief
A Phase 4 clinical trial evaluating Rejuvesol and Blood transfusion for Sickle Cell Disease. Completed, enrolled 4 participants across 2 sites.
Detailed Summary
The objective of this proposal is to test the feasibility of red blood cell (RBC) rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of RBC rejuvenation in this population to determine if a larger clinical trial powered to definitively characterize the benefits of rejuvenation is warranted. This is a small pilot study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6 transfusions (over approximately a 6-month period) in a pre-defined order to maximize detection of any signal.
Study Details
Timeline
Interventions
Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.