Hemanext ONE System for Sickle Cell Anemia
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on iron chelation therapy, you must have been on a stable dose for at least 3 months before joining the study.
Is the Hemanext ONE System safe for humans?
How does the Hemanext ONE System treatment for sickle cell anemia differ from other treatments?
The Hemanext ONE System uses hypoxic red blood cells, which are red blood cells with reduced oxygen levels, to potentially improve their deformability and reduce sickling. This approach is unique because it focuses on altering the oxygen environment of the red blood cells, which is different from traditional treatments that often aim to increase fetal hemoglobin or use medications to prevent sickling.678910
What data supports the effectiveness of the Hemanext ONE System treatment for sickle cell anemia?
Research shows that using hypoxic red blood cells in transfusions is effective and well-tolerated in patients with blood disorders, improving hemoglobin levels. Additionally, treatments that increase hemoglobin's ability to hold onto oxygen have been shown to improve oxygen delivery and reduce sickling in sickle cell disease, suggesting potential benefits for the Hemanext ONE System.17111213
Who Is on the Research Team?
Biree Andemariam, MD
Principal Investigator
New England Sickle Cell Institute, University of Connecticut
Laurel Omert, MD, FACS
Principal Investigator
Hemanext Inc.
Enrico Novelli, MD
Principal Investigator
University of Pittsburgh Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with sickle cell anemia who require red blood cell transfusions. Participants should not have other health conditions that could interfere with the study or be pregnant. The full list of eligibility criteria is detailed in the study's documentation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transfusions of hypoxic red blood cells or conventional red blood cells in a cross-over design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hypoxic Red Blood Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hemanext
Lead Sponsor
University of Connecticut
Collaborator
University of Pittsburgh Medical Center
Collaborator
Johns Hopkins All Children's Hospital
Collaborator
Johns Hopkins University
Collaborator
Emory University
Collaborator