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.
Male or female at least 7 years of age;
Are able to provide informed consent, and assent as applicable, to participate in the study;
Diagnosis of Sickle Cell Anemia (SCA) (HbSS, HbSβ0 thalassemia) with participation in a chronic transfusion program and have undergone regular transfusions during at least 6 months prior to Screening;
Have had an average interval of at least 14 days between RBC transfusions over the past 6 months;
Are not exclusively transfused at the site;
Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)
Are routinely transfused with washed, packed RBC units;
Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;
Hemanext
Lead sponsor
Emory University
Collaborator
University of Connecticut
Collaborator
University of Pittsburgh Medical Center
Collaborator
Johns Hopkins All Children's Hospital
Collaborator
Johns Hopkins University
Collaborator