[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hemanext\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100573194","hypoxic-red-blood-cells-in-sickle-cell-anemia-100573194",false,"NCT06743113","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","Inclusion Criteria:\n\n1. Male or female at least 7 years of age;\n2. Are able to provide informed consent, and assent as applicable, to participate in the study;\n3. 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;\n4. Have had an average interval of at least 14 days between RBC transfusions over the past 6 months;\n5. If on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening;\n\nExclusion Criteria:\n\n1. Are not exclusively transfused at the site;\n2. Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)\n3. Are routinely transfused with washed, packed RBC units;\n4. Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;\n5. Are currently being evaluated for gene therapy;\n6. 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;\n7. Are a female of child-bearing potential who is pregnant or planning to become pregnant in the next 14 months;\n8. Have a history of allo-immunization that cannot be managed by the local blood bank;\n9. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;\n10. Is a ward of the state, prisoner, or transient","ALL","7 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28,29],"Sickle Cell Anaemia","Sickle Cell Anemia Crisis","Sickle Cell Anemia in Children","Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)","NOT_YET_RECRUITING","2026-01-06",{"date":33,"type":34},"2026-01-07","ACTUAL",{"date":36,"type":20},"2026-03",{"date":38,"type":20},"2028-09",{"name":40,"class":41},"Hemanext","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100568793","comparison-of-hemanext-one-system-and-conventional-red-blood-cell-transfusion-100568793","NCT06685848","Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion","Multi-Center, Randomized, Controlled Cross-Over Study to Evaluate Safety and Effectiveness of Hypoxic RBCs Processed With the Hemanext ONE System vs Conventional RBCs in Patients With Transfusion-Dependent Haematological Malignancies","Inclusion Criteria:\n\n* Male or female aged 18 or older\n* Patients with a documented diagnosis of a haematological malignancy requiring chronic transfusions.\n* If MDS patient, Have low risk or intermediate risk MDS per either IPSS-R (https:\u002F\u002Fwww.mds-foundation.org\u002Fipss-r-calculator\u002F) or IPSS-M (IPSS-M Risk Calculator (mds-risk-model.com))\n* If MDS patient, a bone marrow aspirate completed within the 6 months prior to study enrolment, and which did not show progression to higher risk MDS\n* Have RBC transfusion dependence (at least 2 RBC units \u002F8 weeks during the last 16 weeks)\n* Baseline RBC transfusion threshold of 9 g\u002FdL\n* ECOG (Eastern Cooperative Oncology Group) performance status \\< 3\n* Have signed the informed consent form and are willing to comply with the study visits and procedures\n* If on Iron Chelation Therapy, have been on a stable dose for ≥3 months prior to screening\n\nExclusion Criteria:\n\n* Have a life expectancy of less than 1 year\n* Have palpable splenomegaly (more than 3 cm below the mid clavicular line)\n* Have other associated causes of anemia (including auto-immune hemolysis or active hemorrhage, or progression to acute leukemia)\n* If prescribed erythropoiesis affecting disease modifying agents (e.g. G-CSF, erythropoietin), have not been on a stable dose for 90 days\n* Is currently taking Luspatercept or other investigational erythropoiesis affecting disease modifying agent\n* Have severe renal insufficiency with creatinine clearance (MDRD or CKD EPI) below 30ml\u002Fmin\n* Have lung disease with hypoxia or oxygen-dependent\n* Have severe coronary artery disease (including unstable angina or recent myocardial infraction) or severe heart failure (left ventricular ejection fraction less than 30%)\n* Have a history of cancer active in the previous 3 years, except local cervix cancer, or basal cell cutaneous carcinoma\n* Have a history of allo-immunization other than rhesus Kell that cannot be managed by the local blood bank\n* Are a female of child-bearing potential that is pregnant, planning to become pregnant in the next 14 months or breastfeeding\n* Are a patient under guardianship or curatorship\n* Are currently participating in another interventional study evaluating an erythropoiesis affecting disease modifying agent","18 Years",{"count":52,"type":20},24,[23],"The overall objective of this study is to collect preliminary effectiveness and safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.",[56],"Hematologic Neoplasms",[58,59,60],"Transfusion","Red Blood Cells","Hypoxic","RECRUITING",{"date":33,"type":34},{"date":64,"type":34},"2024-11-29",{"date":66,"type":20},"2026-12-15",{"name":40,"class":41},1,""]