Sickle Cell AnaemiaNCT06743113
Hypoxic Red Blood Cells in Sickle Cell Anemia
A study testing Hemanext ONE System and Conventional RBCs in people with Sickle Cell Anaemia and Sickle Cell Anemia Crisis, run by Hemanext at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Sickle Cell Anaemia, Sickle Cell Anemia Crisis, Sickle Cell Anemia in Children
- What is being tested?
- Hemanext ONE System and Conventional RBCs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Sep 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female at least 7 years of age;
- Are able to provide informed consent, and assent as applicable, to participate in the study;
- 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;
- Have had an average interval of at least 14 days between RBC transfusions over the past 6 months;
- If on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening;
Who cannot join
- Are not exclusively transfused at the site;
- Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)
- Are routinely transfused with washed, packed RBC units;
- Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;
- Are currently being evaluated for gene therapy;
- 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;
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- Are a female of child-bearing potential who is pregnant or planning to become pregnant in the next 14 months;
- Have a history of allo-immunization that cannot be managed by the local blood bank;
- Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
- Is a ward of the state, prisoner, or transient
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Ross Fasano, MD, 404-727-5910, ross.fasano@emory.edu
Ross Fasano, MD
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
Elizabeth Crowe, MD, PhD, 443-287-6854, ecrowe3@jhmi.edu
Elizabeth Crowe, MD, PhD
University of Illinois at Chicago
Chicago, Illinois, 60612
Sally A Campbell-Lee, MD, FCAP, CABP, 312-996-3150, scampbe@uic.ed
New England Sickle Cell Institute, University of Connecticut
Farmington, Connecticut, 06030
Biree Andemariam, MD, 860-679-2100, andemariam@uchc.edu
Biree Andemariam, MD
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260
Olubusola B Oluwole, MD, (412) 586-9875, oluwoleob2@upmc.edu
Olubusola B Oluwole, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Sickle Cell Anaemia, Sickle Cell Anemia Crisis, Sickle Cell Anemia in Children, Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
- Being tested
- Hemanext ONE System, Conventional RBCs
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemanext ONE SystemDevice
Hypoxic red blood cells
Conventional RBCsDevice
Conventional red blood cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Hypoxic RBCs) | Experimental | Transfusion of hypoxic red blood cells manufactured with Hemanext ONE system Receives: Device: Hemanext ONE System |
| Treatment B (Conventional RBCs) | Active comparator | Transfusion of conventional red blood cells Receives: Device: Conventional RBCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
%HbA Rate of Decline
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.
Measured: Through study completion, an average of 14 months
Secondary outcomes (13)
Volume of blood transfused
The mean volume of blood per patient transfused with hypoxic RBCs and with standard RBC units will be analyzed and compared
Measured: Through study completion, an average of 14 months
HgbS Rate of Increase
Average rate of increase of the HgbS measurement between automated red cell exchange (RCE) of hypoxic RBCs compared to conventional RBCs.
Measured: Through study completion, an average of 14 months
Incidence rate of vaso-occlusive crisis.
Incidence rate of vaso-occlusive crisis events through the duration of the study
Measured: Through study completion, an average of 14 months
Incidence rate of acute chest syndrome
Incidence rate of acute chest syndrome events accompanied by fever and/or respiratory symptoms through the duration of the study
Measured: Through study completion, an average of 14 months
Duration (days) of any hospitalization for vaso-occlusive crisis
Mean duration (days) of any hospitalization for vaso-occlusive crisis
Measured: Through study completion, an average of 14 months
Intravascular hemolysis
Level of intravascular hemolysis (measured with free plasma hemoglobin) between each procedure, before and after each Red Cell Exchange.
Measured: Through study completion, an average of 14 months
Serum ferritin
Mean change from baseline in serum ferritin
Measured: Through study completion, an average of 14 months
Changes in hepatic iron content
Mean changes in hepatic iron content
Measured: Through study completion, an average of 14 months
Change in QoL
Mean change in QoL, as measured by validated QoL questionnaires
Measured: Through study completion, an average of 14 months
Total hemoglobin before and after RCE
Mean change before and after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Measured: Through study completion, an average of 14 months
Total hematocrit before and after RCE
Mean change before and after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Measured: Through study completion, an average of 14 months
Red Cell Exchange events
Mean number of RCE events over the course of the study
Measured: Through study completion, an average of 14 months
Safety assessment
Frequency of adverse event reactions and device deficiencies over the course of the study
Measured: Through study completion, an average of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each enrolled patient will be randomized to treatment with either hypoxic RBCs or conventional RBCs after successful completion of the screening period. After 6 months in the randomized treatment arm, two "Wash Out" transfusions of conventional RBCs will be scheduled. The patient will then "cross-over" into the other treatment arm to complete another 6 months of treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemanext
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University, University of Connecticut, University of Pittsburgh Medical Center, Johns Hopkins University, University of Illinois at Chicago, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Biree Andemariam, MD, Principal investigator, New England Sickle Cell Institute, University of ConnecticutLaurel Omert, MD, FACS, Principal investigator, Hemanext Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743113
- Sponsor's protocol ID
- PRO-CLIN-0017
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06743113
- Acronym / sponsor ID
- PRO-CLIN-0017
- Conditions
- Sickle Cell Anaemia, Sickle Cell Anemia Crisis, Sickle Cell Anemia in Children, Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- HemanextIndustry (pharma, biotech, devices)
- Collaborators
- Emory University, University of Connecticut, University of Pittsburgh Medical Center, Johns Hopkins University, University of Illinois at Chicago, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each enrolled patient will be randomized to treatment with either hypoxic RBCs or conventional RBCs after successful completion of the screening period. After 6 months in the randomized treatment arm, two "Wash Out" transfusions of conventional RBCs will be scheduled. The patient will then "cross-over" into the other treatment arm to complete another 6 months of treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Hypoxic RBCs) | Experimental | Device: Hemanext ONE SystemTransfusion of hypoxic red blood cells manufactured with Hemanext ONE system |
| Treatment B (Conventional RBCs) | Active comparator | Device: Conventional RBCsTransfusion of conventional red blood cells |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 7 years of age;
- Are able to provide informed consent, and assent as applicable, to participate in the study;
- 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;
- Have had an average interval of at least 14 days between RBC transfusions over the past 6 months;
- If on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening;
Key exclusion criteria (10 listed)
- Are not exclusively transfused at the site;
- Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)
- Are routinely transfused with washed, packed RBC units;
- Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;
- Are currently being evaluated for gene therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemanext ONE SystemHypoxic red blood cells | Device | Treatment A (Hypoxic RBCs) |
| Conventional RBCsConventional red blood cells | Device | Treatment B (Conventional RBCs) |
Primary outcome
%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.
13 secondary outcomes
Volume of blood transfused
Time frame: Through study completion, an average of 14 months
HgbS Rate of Increase
Time frame: 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 acute chest syndrome
Time frame: 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
Intravascular hemolysis
Time frame: Through study completion, an average of 14 months
Serum ferritin
Time frame: Through study completion, an average of 14 months
Changes in hepatic iron content
Time frame: Through study completion, an average of 14 months
Change in QoL
Time frame: Through study completion, an average of 14 months
Total hemoglobin before and after RCE
Time frame: Through study completion, an average of 14 months
Total hematocrit before and after RCE
Time frame: Through study completion, an average of 14 months
Red Cell Exchange events
Time frame: Through study completion, an average of 14 months
Safety assessment
Time frame: Through study completion, an average of 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biree Andemariam, MD principal investigator
New England Sickle Cell Institute, University of Connecticut
Laurel Omert, MD, FACS principal investigator
Hemanext Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemanext ONE System and Conventional RBCs in people with Sickle Cell Anaemia and Sickle Cell Anemia Crisis, run by Hemanext at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Bagdasarian ((781) 301-7474, jill.bagdasarian@hemanext.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%HbA Rate of Decline (time frame: Through study completion, an average of 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.