[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100200115":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":23,"responsibleParty":41,"collaborators":44,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":7,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":7,"maxAge":57,"enrollmentInfo":7,"targetDuration":7,"studyType":58,"phases":7,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Duke University","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","CliniMACS CD34 Reagent System","The CliniMACS CD34 Reagent System is a medical device that is used in vitro to select and enrich CD34+ cells from heterogeneous hematologic cell populations for transplantation in cases where this is clinically indicated.",[14],{"name":15,"affiliation":5,"role":16},"Joanne Kurtzberg, MD","PRINCIPAL_INVESTIGATOR",[18],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"Erin Arbuckle","CONTACT","919-684-3293","erin.arbuckle@duke.edu",[24],{"facility":25,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Duke University Medical Center","AVAILABLE","Durham","North Carolina","27710","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-78.89862,35.99403,{"lat":36,"lon":35},[39,40],{"name":19,"role":20,"phone":7,"phoneExt":7,"email":22},{"name":15,"role":16,"phone":7,"phoneExt":7,"email":7},{"type":42,"investigatorFullName":15,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","MD",[45,46],{"name":5,"class":6},{"name":47,"class":48},"Miltenyi Biotec, Inc.","INDUSTRY","100200115","expanded-access-to-t-cell-depleted-haplo-identical-stem-cells-for-patients-receiving-haplo-identical-and-unrelated-cord-blood-transplants-100200115",false,"NCT01881334","Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants","A Compassionate Release Protocol: Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Allogeneic Transplantation Using a Related Haplo-Identical Donor and Unrelated, Umbilical Cord Blood Donor(s) for the Treatment of High Risk Malignancies or Non-Malignant Disorders Requiring Allogeneic Transplantation","Inclusion Criteria:\n\n* Have a consenting related haplo-identical (3\u002F6, 4\u002F6, or 5\u002F6 if DRB1 mismatch) stem cell donor.\n* Have one or two available 4, 5, or 6\u002F6 antigen matching unrelated UCB unit(s) that will deliver a total cell dose \\>3.0 x 10e7 cells\u002Fkg. Patients who do not have a single UCB unit that will deliver the minimum required cell dose, two partially HLA-matched UCB units which together meet the minimum cell dose requirement, can be used for 1 transplant. These units must be HLA-matched minimally at 4 of 6 HLA-A and B (at intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing) loci with the patient, and HLA-matched at 3 of 6 HLA- A, B, DRB1 loci with each other (using same resolution of HLA typing as indicated above). There is no limitation on maximum cell dose.\n* Have a high risk or refractory malignancy, or non-malignant disorder amenable to stem cell transplantation therapy.\n* Meet eligibility requirements for allogeneic transplant per institutional standard practices.\n* Have given written informed consent according to FDA guidelines (or consent of parent\u002Flegal guardian as applicable).\n* Be \\\u003C65 years of age at the time of study enrollment.\n\nExclusion Criteria:\n\n* Have a consenting 8\u002F8 or 10\u002F10 allele matched, consenting, related or unrelated hematopoietic stem cell transplant (HSCT) donor.\n* Have a life expectancy of less than 3 months.\n* Have uncontrolled infections at time of cytoreduction.","ALL","65 Years","EXPANDED_ACCESS","The objective of this study is to make T-cell depleted stem cells from a family member who is a half match (haplo-identical) available on an expanded access basis to patients receiving one or two unrelated cord blood transplants who are at a higher risk of not engrafting in a safe amount of time. The purpose of the related stem cells is to give the bone marrow a \"jump start\" towards recovery. Ultimately, the cord blood cells will grow and permanently rescue the bone marrow.",[61,62,63],"Hematologic Malignancies","Inborn Errors of Metabolism Disorders","Immune Deficiencies",[65,66,67,68,69,70,71,72,73,74,56,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"Haploidentical Donor","T-cell depleted Stem Cells","Allogeneic Transplant","Umbilical Cord Blood Donor","High Risk Malignancies","Metabolic Disorders","Immune Deficiency","Acute Lymphoblastic Leukemia","Acute Myelogenous Leukemia","Myelodysplastic Syndrome","AML","MDS","CGD","SCID","Adrenoleukodystrophy","Metachromaticleukodystrophy","Krabbe","PMD","Hunter's","Hurler's","Severe Aplastic Anemia","Lymphoma","Sickle Cell Disease","Thalassemia","2025-11-17",{"date":91,"type":92},"2025-11-20","ACTUAL",{"name":15,"class":6},1]