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Hypoxic Red Blood Cells in Sickle Cell Anemia

NCT06743113 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Hemanext ONE System

Hypoxic red blood cells

DEVICE

Conventional RBCs

Conventional red blood cells

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • University of Connecticut

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Johns Hopkins All Children's Hospital

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Hemanext

    lead INDUSTRY

Principal Investigators

  • Enrico Novelli, MD, MS · University of Pittsburgh Medical Center

  • Biree Andemariam, MD · New England Sickle Cell Institute, University of Connecticut

  • Laurel Omert, MD, FACS · Hemanext Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-04-30
Completion
2028-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06743113 on ClinicalTrials.gov