Hypoxic Red Blood Cells in Sickle Cell Anemia

Starting soon · Not applicable

Conditions studied: Sickle Cell Anaemia, Sickle Cell Anemia Crisis, Sickle Cell Anemia in Children, Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)

In brief

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.

Key facts

Study ID

NCT06743113

Run by

Hemanext

People needed

48

Starts

2026-03-01

Expected to finish

2028-09-01

Last updated by the study team

2026-01-07

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;
• 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;
• Are a female of child-bearing potential who is pregnant or planning to become pregnant in the next 14 months;
• Have a history of allo-immunization that cannot be managed by the local blood bank;
• 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

Where it is running

• New England Sickle Cell Institute, University of Connecticut — Farmington, Connecticut, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• John Hopkins University School of Medicine — Baltimore, Maryland, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.