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

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

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

First listed
Dec 19, 2024
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Apr 1, 2029
Completion
Oct 1, 2029

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 (5)

FacilityCityStateZIPSite coordinators
New England Sickle Cell Institute, University of ConnecticutFarmingtonConnecticut06030
Biree Andemariam, MD
[email protected]
860-679-2100
Biree Andemariam, MD (PRINCIPAL_INVESTIGATOR)
Emory University School of MedicineAtlantaGeorgia30322
Ross Fasano, MD
[email protected]
404-727-5910
Ross Fasano, MD (PRINCIPAL_INVESTIGATOR)
University of Illinois at ChicagoChicagoIllinois60612
Sally A Campbell-Lee, MD, FCAP, CABP
[email protected]
312-996-3150
John Hopkins University School of MedicineBaltimoreMaryland21287
Elizabeth Crowe, MD, PhD
[email protected]
443-287-6854
Elizabeth Crowe, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15260
Olubusola B Oluwole, MD
[email protected]
(412) 586-9875
Olubusola B Oluwole, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Farmington, CT

By research site
New England Sickle Cell Institute, University of Connecticut· Farmington, CTEmory University School of Medicine· Atlanta, GAUniversity of Illinois at Chicago· Chicago, ILJohn Hopkins University School of Medicine· Baltimore, MDUniversity of Pittsburgh Medical Center· Pittsburgh, PA

Related Studies