Hemanext ONE System for Sickle Cell Anemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for sickle cell anemia using specially prepared red blood cells. Researchers aim to determine if these hypoxic red blood cells—created with the Hemanext ONE system—are safe and more effective than regular ones. Individuals with sickle cell anemia who receive regular blood transfusions may qualify if they haven't needed blood more frequently than every two weeks in the past six months. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in sickle cell anemia treatment.
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.
What prior data suggests that the Hemanext ONE system is safe for patients with sickle cell anemia?
Research has shown that special red blood cells, called hypoxic RBCs, are safe. In earlier studies, patients tolerated these RBCs well. For example, one study found that using these RBCs increased hemoglobin levels by 17%, and these levels remained elevated. This suggests they are both effective and safe.
Hypoxic RBCs are also designed to be of better quality and last longer in the body than regular red blood cells. This means they might function more effectively and persist longer in the body. These findings offer promising evidence that the treatment could be safe for individuals with sickle cell anemia.12345Why are researchers excited about this trial's treatment?
Most treatments for sickle cell anemia involve the transfusion of conventional red blood cells (RBCs) to relieve symptoms and prevent complications. However, the Hemanext ONE System introduces a novel approach by utilizing hypoxic red blood cells. This method creates RBCs under low-oxygen conditions, which researchers believe could enhance the cells’ lifespan and functionality once transfused. Unlike traditional RBC transfusions, this could potentially reduce the frequency of transfusions and improve the overall health outcomes for patients with sickle cell anemia. Researchers are excited about the possibility of these hypoxic RBCs offering more effective management of the disease, with fewer side effects and complications.
What evidence suggests that the Hemanext ONE system is effective for sickle cell anemia?
Research has shown that red blood cells stored with less oxygen, known as hypoxic red blood cells, recover better after transfusion. Studies have found that these cells maintain their energy and function more effectively, leading to improved recovery in healthy individuals. An early review indicated that transfusions with hypoxic red blood cells are both effective and safe for patients. Additionally, a cost analysis suggests that using hypoxic red blood cells offers more health benefits than standard ones. In this trial, participants will receive either hypoxic red blood cells manufactured with the Hemanext ONE system or conventional red blood cells. These findings suggest that hypoxic red blood cells could be a promising treatment for conditions like sickle cell anemia.13467
Who Is on the Research Team?
Biree Andemariam, MD
Principal Investigator
New England Sickle Cell Institute, University of Connecticut
Enrico Novelli, MD
Principal Investigator
University of Pittsburgh Medical Center
Laurel Omert, MD, FACS
Principal Investigator
Hemanext Inc.
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