Hypoxic Red Blood Cells in Sickle Cell Anemia

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Hemanext
Study ID
NCT06743113
Status
Not Yet Recruiting

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Conditions

  • Sickle Cell Anaemia
  • Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
  • Sickle Cell Anemia Crisis
  • Sickle Cell Anemia in Children

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hemanext ONE System — DEVICE
    Hypoxic red blood cells
  • Conventional RBCs — DEVICE
    Conventional red blood cells

Study Details

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 Dates

Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A (Hypoxic RBCs)
    Transfusion of hypoxic red blood cells manufactured with Hemanext ONE system
  • Active Comparator: Treatment B (Conventional RBCs)
    Transfusion of conventional red blood cells

Primary Outcome Measure

%HbA Rate of Decline [ Time Frame: Through study completion, an average of 14 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
New England Sickle Cell Institute, University of ConnecticutFarmingtonConnecticut06030
Biree Andemariam, MD
[email protected]
860-679-2100
Biree Andemariam, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701
Cassandra Josephson, MD
[email protected]
727-767-8884
Cassandra Josephson, MD (PRINCIPAL_INVESTIGATOR)
Emory University School of MedicineAtlantaGeorgia30322
Ross Fasano, MD
[email protected]
404-727-5910
Ross Fasano, MD (PRINCIPAL_INVESTIGATOR)
John Hopkins University School of MedicineBaltimoreMaryland21287
Elizabeth Crowe, MD, PhD
[email protected]
443-287-6854
Elizabeth Crowe, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213
Alesia Kaplan, MD
[email protected]
412-209-7238
Alesia Kaplan, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15260
Enrico Novelli, MD, MS
[email protected]
412-624-2591
Enrico Novelli, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Farmington, CT

By research site
New England Sickle Cell Institute, University of Connecticut· Farmington, CTJohns Hopkins All Children's Hospital· St. Petersburg, FLEmory University School of Medicine· Atlanta, GAJohn Hopkins University School of Medicine· Baltimore, MDUniversity of Pittsburgh· Pittsburgh, PAUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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