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
Hemanext
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.
Description
In this Direct-to-Phase II study, Hemanext Inc. will carry out a prospective, multi-center, single-blind, randomized, cross-over study in patients with Sickle Cell Anemia, comparing the efficacy of transfusion of hypoxic red blood cells (HRBCs) to transfusions with conventional RBCs. The primary efficacy objective is to demonstrate an increase in %HbA between red cell exchange transfusions (RCE) of HRBCs compared to conventional RBCs. The increases in %HbA (normal Hb) from RCE will be accompanied by a concomitant decrease in sickle Hb (%HbS). The persistence of %HbA will allow for a decrease i…
Eligibility
- Age range
- 7+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female at least 7 years of age; 2. Are able to provide informed consent, and assent as applicable, to participate in the study; 3. 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; 4. Have had an average interval of at least 14 days between RBC transfusions over the past 6 months; 5. If on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening; Exclusion Criteria: 1. Are not exclusiv…
Interventions
- DeviceHemanext ONE System
Hypoxic red blood cells
- DeviceConventional RBCs
Conventional red blood cells
Locations (6)
- New England Sickle Cell Institute, University of ConnecticutFarmington, Connecticut
- Johns Hopkins All Children's HospitalSt. Petersburg, Florida
- Emory University School of MedicineAtlanta, Georgia
- John Hopkins University School of MedicineBaltimore, Maryland
- University of PittsburghPittsburgh, Pennsylvania
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania