48 Participants Needed

Hemanext ONE System for Sickle Cell Anemia

Recruiting at 5 trial locations
JB
Overseen ByJill Bagdasarian
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Hemanext
Must be taking: Iron chelation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The studies reviewed indicate that red blood cell exchange systems, including automated and manual methods, are generally safe for patients with sickle cell disease, with no serious adverse reactions reported.12345

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?

Dr. Biree Andemariam, Hematologist and ...

Biree Andemariam, MD

Principal Investigator

New England Sickle Cell Institute, University of Connecticut

LO

Laurel Omert, MD, FACS

Principal Investigator

Hemanext Inc.

EN

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

Are able to provide informed consent, and assent as applicable, to participate in the study
I've needed a blood transfusion about every 2 weeks for the last 6 months.
I have been on a consistent dose of iron chelation therapy for 3 months or more.
See 2 more

Exclusion Criteria

I regularly receive blood transfusions with specific preparation.
Is a ward of the state, prisoner, or transient
I have not taken any drugs to increase my red blood cells in the last 30 days.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transfusions of hypoxic red blood cells or conventional red blood cells in a cross-over design

14 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Hypoxic Red Blood Cells
Trial Overview The trial is testing the safety and effectiveness of hypoxic red blood cells processed by the Hemanext ONE system compared to conventional red blood cells in patients with sickle cell anemia.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment A (Hypoxic RBCs)Experimental Treatment1 Intervention
Group II: Treatment B (Conventional RBCs)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hemanext

Lead Sponsor

Trials
5
Recruited
190+

University of Connecticut

Collaborator

Trials
194
Recruited
162,000+

University of Pittsburgh Medical Center

Collaborator

Trials
78
Recruited
77,600+

Johns Hopkins All Children's Hospital

Collaborator

Trials
47
Recruited
5,009,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Published Research Related to This Trial

Automated red blood cell exchange (aRBCX) was found to be more effective than manual exchange transfusion (MET) in reducing the percentage of sickle hemoglobin (HbS) in adult patients with sickle cell disease, leading to better disease control and fewer hospital visits.
Despite requiring more packed red blood cells (pRBCs) for aRBCX, patients experienced significantly lower ferritin levels, indicating better iron management and a reduced risk of complications associated with chronic transfusions.
Comparative study between chronic automated red blood cell exchange and manual exchange transfusion in patients with sickle cell disease: A single center experience from Saudi Arabia.Al Mozain, N., Elobied, Y., Al-Omran, A., et al.[2023]

Citations

Automated Oxygen Gradient Ektacytometry: A Novel Biomarker in Sickle Cell Anemia. [2021]
Priming With Red Blood Cells Allows Red Blood Cell Exchange for Sickle Cell Disease in Low-Weight Children. [2022]
Comparative efficacy in red blood cell exchange transfusions with different apheresis machines in patients with sickle cell disease. [2020]
Safety of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies: An interim analysis. [2023]
Increased hemoglobin affinity for oxygen with GBT1118 improves hypoxia tolerance in sickle cell mice. [2022]
Automated RBC exchange compared to manual exchange transfusion for children with sickle cell disease is cost-effective and reduces iron overload. [2018]
Comparative study between chronic automated red blood cell exchange and manual exchange transfusion in patients with sickle cell disease: A single center experience from Saudi Arabia. [2023]
Manual erythroexchange in sickle cell disease: multicenter validation of a protocol predictive of volume to exchange and hemoglobin values. [2020]
Selecting red blood cell units to perform RBCX in patients with sickle cell disease. [2019]
OcclusionChip: A functional microcapillary occlusion assay complementary to ektacytometry for detection of small-fraction red blood cells with abnormal deformability. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Individual red blood cell fetal hemoglobin quantification allows to determine protective thresholds in sickle cell disease. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Rapid and reproducible characterization of sickling during automated deoxygenation in sickle cell disease patients. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Oxygen-dependent flow of sickle trait blood as an in vitro therapeutic benchmark for sickle cell disease treatments. [2020]
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