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New blood processing method could cut transfusion needs for sickle cell patients

NCT ID NCT06743113

Disease control Sponsor: Hemanext Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This study tests whether red blood cells processed to be low in oxygen (hypoxic) last longer in the body than standard cells for people with sickle cell anemia who need regular transfusions. About 48 participants aged 7 and older will receive both types of blood in a crossover design. The goal is to see if hypoxic cells slow the drop in healthy hemoglobin levels, potentially reducing how often transfusions are needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hypoxic red blood cells processed with the Hemanext ONE system
What this could lead to
If it works, this could reduce how often patients with sickle cell anemia need transfusions, easing treatment burden.
What could go wrong
This is a small early-stage trial with only 48 participants, so results may not apply to everyone. The device is new, and long-term benefits or risks are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

sickle cell disease Vaso-Occlusive Crises

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell anaemia Sickle cell anemia (HBSS, or HBSΒ-THALASSEMIA0) Sickle cell anemia crisis Sickle cell anemia in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • John Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • New England Sickle Cell Institute, University of Connecticut

    Farmington, Connecticut, 06030, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15260, United States

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