Hypoxic Red Blood Cells in Sickle Cell Anemia

August 13, 2026 updated by: Hemanext

A Multi-Center, Randomized, Controlled, Cross-Over Study to Evaluate the Effectiveness of Hypoxic Red Blood Cells Processed With the Hemanext ONE® System Versus Conventional Red Blood Cells in Patients With Transfusion Dependent Sickle Cell Anemia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this Direct-to-Phase II study, Hemanext Inc. will carry out a prospective, multi-center, single-blind, randomized, cross-over study in patients with Sickle Cell Anemia, comparing the efficacy of transfusion of hypoxic red blood cells (HRBCs) to transfusions with conventional RBCs. The primary efficacy objective is to demonstrate an increase in %HbA between red cell exchange transfusions (RCE) of HRBCs compared to conventional RBCs. The increases in %HbA (normal Hb) from RCE will be accompanied by a concomitant decrease in sickle Hb (%HbS). The persistence of %HbA will allow for a decrease in the volume of RBCs transfused with an overall decrease in the number of units consumed, which in turn can result in an increase in time (number of days) between transfusions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • New England Sickle Cell Institute, University of Connecticut
        • Principal Investigator:
          • Biree Andemariam, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
        • Contact:
        • Principal Investigator:
          • Ross Fasano, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
        • Contact:
          • Sally A Campbell-Lee, MD, FCAP, CABP
          • Phone Number: 312-996-3150
          • Email: scampbe@uic.ed
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins University School of Medicine
        • Contact:
        • Principal Investigator:
          • Elizabeth Crowe, MD, PhD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Olubusola B Oluwole, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female at least 7 years of age;
  2. Are able to provide informed consent, and assent as applicable, to participate in the study;
  3. Diagnosis of Sickle Cell Anemia (SCA) (HbSS, HbSβ0 thalassemia) with participation in a chronic transfusion program and have undergone regular transfusions during at least 6 months prior to Screening;
  4. Have had an average interval of at least 14 days between RBC transfusions over the past 6 months;
  5. If on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening;

Exclusion Criteria:

  1. Are not exclusively transfused at the site;
  2. Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)
  3. Are routinely transfused with washed, packed RBC units;
  4. Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;
  5. Are currently being evaluated for gene therapy;
  6. Have any clinically significant pulmonary, cardiovascular, endocrine, hepatic, gastrointestinal, renal, infectious, immunological (including significant allo- or auto-immunization) disease, considered not adequately controlled prior to the study;
  7. Are a female of child-bearing potential who is pregnant or planning to become pregnant in the next 14 months;
  8. Have a history of allo-immunization that cannot be managed by the local blood bank;
  9. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
  10. Is a ward of the state, prisoner, or transient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment A (Hypoxic RBCs)
Transfusion of hypoxic red blood cells manufactured with Hemanext ONE system
Device: Hemanext ONE System
Hypoxic red blood cells
Active Comparator: Treatment B (Conventional RBCs)
Transfusion of conventional red blood cells
Device: Conventional RBCs
Conventional red blood cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
%HbA Rate of Decline
Time Frame: Through study completion, an average of 14 months
The primary objective is to evaluate the decreased rate of decline of %HbA between post-transfusion RCE and the subsequent pre-transfusion RCE over 6 transfusion cycles in the hypoxic RBC group compared to the conventional group.
Through study completion, an average of 14 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volume of blood transfused
Time Frame: Through study completion, an average of 14 months
The mean volume of blood per patient transfused with hypoxic RBCs and with standard RBC units will be analyzed and compared
Through study completion, an average of 14 months
HgbS Rate of Increase
Time Frame: Through study completion, an average of 14 months
Average rate of increase of the HgbS measurement between automated red cell exchange (RCE) of hypoxic RBCs compared to conventional RBCs.
Through study completion, an average of 14 months
Incidence rate of vaso-occlusive crisis.
Time Frame: Through study completion, an average of 14 months
Incidence rate of vaso-occlusive crisis events through the duration of the study
Through study completion, an average of 14 months
Incidence rate of acute chest syndrome
Time Frame: Through study completion, an average of 14 months
Incidence rate of acute chest syndrome events accompanied by fever and/or respiratory symptoms through the duration of the study
Through study completion, an average of 14 months
Duration (days) of any hospitalization for vaso-occlusive crisis
Time Frame: Through study completion, an average of 14 months
Mean duration (days) of any hospitalization for vaso-occlusive crisis
Through study completion, an average of 14 months
Intravascular hemolysis
Time Frame: Through study completion, an average of 14 months
Level of intravascular hemolysis (measured with free plasma hemoglobin) between each procedure, before and after each Red Cell Exchange.
Through study completion, an average of 14 months
Serum ferritin
Time Frame: Through study completion, an average of 14 months
Mean change from baseline in serum ferritin
Through study completion, an average of 14 months
Changes in hepatic iron content
Time Frame: Through study completion, an average of 14 months
Mean changes in hepatic iron content
Through study completion, an average of 14 months
Change in QoL
Time Frame: Through study completion, an average of 14 months
Mean change in QoL, as measured by validated QoL questionnaires
Through study completion, an average of 14 months
Total hemoglobin before and after RCE
Time Frame: Through study completion, an average of 14 months
Mean change before and after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Through study completion, an average of 14 months
Total hematocrit before and after RCE
Time Frame: Through study completion, an average of 14 months
Mean change before and after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Through study completion, an average of 14 months
Red Cell Exchange events
Time Frame: Through study completion, an average of 14 months
Mean number of RCE events over the course of the study
Through study completion, an average of 14 months
Safety assessment
Time Frame: Through study completion, an average of 14 months
Frequency of adverse event reactions and device deficiencies over the course of the study
Through study completion, an average of 14 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemoglobin increment from each transfusion
Time Frame: Through study completion, an average of 14 months
The hemoglobin increment from each transfusion will be determined by calculating the difference between the patient's post-transfusion and pre-transfusion hemoglobin. It will then be corrected for estimated patient blood volume and the amount of Hb transfused
Through study completion, an average of 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hemanext

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
University of Illinois at Chicago
Emory University
University of Connecticut
University of Pittsburgh Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Biree Andemariam, MD, New England Sickle Cell Institute, University of Connecticut
  • Principal Investigator: Laurel Omert, MD, FACS, Hemanext Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-CLIN-0017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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