Tests oxygen-treated blood cell transfusions in people with sickle cell anemia
Compares hypoxic red blood cell transfusions with conventional transfusions in transfusion-dependent sickle cell anemia patients.
Plain-language title generated from the registry record
Registry title: Hypoxic Red Blood Cells in Sickle Cell Anemia
Key facts
- Where
- Atlanta, Baltimore, Chicago, Farmington, and Pittsburgh, United StatesSee the 5 sites
Where in United States
- Emory University School of MedicineAtlanta, United StatesNo longer taking part
- John Hopkins University School of MedicineBaltimore, United StatesNo longer taking part
- University of Illinois at ChicagoChicago, United StatesNo longer taking part
- New England Sickle Cell Institute, University of ConnecticutFarmington, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hemanext
- Trial code
- NCT06743113
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
A Multi-Center, Randomized, Controlled, Cross-Over Study to Evaluate the Effectiveness of Hypoxic Red Blood Cells Processed With the Hemanext ONE® System Versus Conventional Red Blood Cells in Patients With Transfusion Dependent Sickle Cell Anemia
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.
Inclusion: 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; If on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening.
Exclusion: Are currently being evaluated for gene therapy; Have any clinically significant pulmonary, cardiovascular, endocrine, hepatic, gastrointestinal, renal, infectious, immunological (including significant allo- or auto-immunization) disease, considered not adequately controlled prior to the study; Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia); Have a history of allo-immunization that cannot be managed by the local blood bank; Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening; Are not exclusively transfused at the site; Are routinely transfused with washed, packed RBC units; Are a female of child-bearing potential who is pregnant or planning to become pregnant in the next 14 months; Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol; Is a ward of the state, prisoner, or transient.