Hypoxic Red Blood Cells in Sickle Cell Anemia
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 7 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective red blood cells with reduced oxygen are for blood transfusions. The cells are prepared with the Hemanext ONE system. It is for people age 7 or older with certain types of sickle cell anemia who get regular blood transfusions.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 7 years old.
- Be able to give informed consent and assent, as needed, to join the study.
- Have sickle cell anemia of the HbSS or HbSβ0 thalassemia type and have had regular blood transfusions for at least 6 months before screening.
- Have had at least 14 days between red blood cell transfusions, on average, over the past 6 months.
- If taking medicine to remove extra iron, have used a stable dose for at least 3 months before screening.
Who can't join
- Get any blood transfusions outside the study site, or routinely get washed, packed red blood cells.
- Have HbSC disease, HbSβ+ thalassemia, or a sickle cell type other than HbSS or HbSβ0 thalassemia.
- Have taken medicine that raises hemoglobin, such as erythropoietin, in the 30 days before screening. Hemoglobin is the protein in red blood cells that carries oxygen.
- Are currently being checked to see if you can get gene therapy.
- Have a serious health problem that is not well controlled, affecting the lungs, heart, hormones, liver, gut, kidneys, or immune system, or have a serious uncontrolled infection.
- Have immune reactions to donated blood that the local blood bank cannot manage.
- Are pregnant or plan to become pregnant in the next 14 months.
- The study doctor thinks you cannot or will not follow study rules, or you are in state custody, a prisoner, or a person without a fixed home.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (5)
CT
- New England Sickle Cell Institute, University of Connecticut · Farmington, CT 06030Biree Andemariam, MD · Study contact · 860-679-2100 · andemariam@uchc.eduBiree Andemariam, MD · Principal investigatorMore trials in Farmington
GA
- Emory University School of Medicine · Atlanta, GA 30322Ross Fasano, MD · Study contact · 404-727-5910 · ross.fasano@emory.eduRoss Fasano, MD · Principal investigatorMore trials in Atlanta
IL
- University of Illinois at Chicago · Chicago, IL 60612Sally A Campbell-Lee, MD, FCAP, CABP · Study contact · 312-996-3150 · scampbe@uic.edMore trials in Chicago
MD
- John Hopkins University School of Medicine · Baltimore, MD 21287Elizabeth Crowe, MD, PhD · Study contact · 443-287-6854 · ecrowe3@jhmi.eduElizabeth Crowe, MD, PhD · Principal investigatorMore trials in Baltimore
PA
- University of Pittsburgh Medical Center · Pittsburgh, PA 15260Olubusola B Oluwole, MD · Study contact · (412) 586-9875 · oluwoleob2@upmc.eduOlubusola B Oluwole, MD · Principal investigatorMore trials in Pittsburgh