Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
48 participants
INTERVENTIONAL
2026-01-31
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment A (Hypoxic RBCs)
Transfusion of hypoxic red blood cells manufactured with Hemanext ONE system
Hemanext ONE System
Hypoxic red blood cells
Treatment B (Conventional RBCs)
Transfusion of conventional red blood cells
Conventional RBCs
Conventional red blood cells
Interventions
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Hemanext ONE System
Hypoxic red blood cells
Conventional RBCs
Conventional red blood cells
Eligibility Criteria
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Inclusion Criteria
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
2. Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)
3. Are routinely transfused with washed, packed RBC units;
4. Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;
5. Are currently being evaluated for gene therapy;
6. 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;
7. Are a female of child-bearing potential who is pregnant or planning to become pregnant in the next 14 months;
8. Have a history of allo-immunization that cannot be managed by the local blood bank;
9. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
10. Is a ward of the state, prisoner, or transient
7 Years
ALL
No
Sponsors
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Emory University
OTHER
University of Connecticut
OTHER
University of Pittsburgh Medical Center
OTHER
Johns Hopkins All Children's Hospital
OTHER
Johns Hopkins University
OTHER
Hemanext
INDUSTRY
Responsible Party
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Principal Investigators
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Enrico Novelli, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Biree Andemariam, MD
Role: PRINCIPAL_INVESTIGATOR
New England Sickle Cell Institute, University of Connecticut
Laurel Omert, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Hemanext Inc.
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Biree Andemariam, MD
Role: primary
Cassandra Josephson, MD
Role: primary
Ross Fasano, MD
Role: primary
Elizabeth Crowe, MD, PhD
Role: primary
Alesia Kaplan, MD
Role: primary
Enrico Novelli, MD, MS
Role: primary
Other Identifiers
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PRO-CLIN-0017
Identifier Type: -
Identifier Source: org_study_id