Clinical Trial

Hypoxic Red Blood Cells in Sickle Cell Anemia

Not Yet Recruiting
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Summary
The overall objective of this study is to evaluate the effectiveness and safety of transfusing hypoxic red blood cells manufactured with the Hemanext ONE system in patients with sickle cell anemia. The Hemanext ONE device was cleared through the De Novo process in September 2023.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-04 -> 2029-04 2026-08-12
minor Completion pushed: 2028-09 -> 2029-10 2026-08-12
Trial Details
NCT Number NCT06743113
Lead Sponsor Hemanext
Collaborators: Emory University, University of Connecticut, University of Pittsburgh Medical Center, Johns Hopkins University, University of Illinois at Chicago, National Heart, Lung, and Blood Institute (NHLBI)
Conditions Sickle Cell Anaemia, Sickle Cell Anemia Crisis, Sickle Cell Anemia in Children, Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
Enrollment 48 participants
Start Date 2026-09
Primary Completion 2029-04 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-11