[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559818":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":56,"collaborators":28,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":28,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":28,"enrollmentInfo":67,"targetDuration":28,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":28,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Individuals with Poor Graft Function or Failure Following Allogeneic HSCT","EXPERIMENTAL","The recipient will undergo evaluations, then undergo a single infusion of CD34 selected HSCT from the original donor.\n\nNo additional GvHD prophylaxis will be administered. Patients who develop GvHD will receive the standard of care based on the discretion of the treating physician .\n\nPatients will receive supportive care per institutional standards and at the discretion of the treating physician.",[13,14],"Device: CD34+ Selected Donor Cell Boost","Procedure: Blood Stem Cell Infusion",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","CD34+ Selected Donor Cell Boost","The CliniMACS CD34 Reagent System is used to separate CD34 cells from the remaining stem cell product, using a peripheral blood stem cell sample provided by the original donor. These CD34 cells are then infused into the recipient following selection with the intent to restore function of the blood forming cells.",[9],[22],"CliniMACS CD34 Reagent System",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Blood Stem Cell Infusion","The selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.",[9],null,[30],{"name":31,"affiliation":5,"role":32},"Jingmei Hsu","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Kiselle Mangalindan","CONTACT","646-501-2973","KiselleAnne.Mangalindan@nyulangone.org",{"name":40,"role":36,"phone":41,"phoneExt":28,"email":42},"Kelsey Stocker","646-501-4848","Kelsey.Stocker@nyulangone.org",[44],{"facility":5,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":28},"RECRUITING","New York","10016","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-74.00597,40.71427,{"lat":54,"lon":53},{"type":57,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100559818","cd34-selected-stem-cell-for-poor-graft-function-or-graft-failure-100559818",false,"NCT06569082","CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure","CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.\n* Documented evidence of graft dysfunction or failure (a-c):\n\n  1. Primary graft Failure: Graft failure is defined as failure to achieve neutrophil engraftment by day +28 or lack of donor chimerism \\> 50% by day 45 not due to the underlying malignancy;\n  2. Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin \\\u003C 8 g\u002FdL, ANC \\\u003C 0.5x109\u002FL, and platelets \\\u003C 20x109\u002FL. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;\n  3. Secondary graft failure is defined as poor graft function associated with donor chimerism \\\u003C 5% after initial engraftment\n* Transplanted donor availability\n* Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.\n\nExclusion Criteria:\n\n* Graft failure due to disease relapse or evidence of disease relapse or progression\n* Donor unavailable or unable to collect peripheral HPC by apheresis\n* Responsive to conventional measures (such as, hematopoietic growth factor)\n* Allergic reaction to murine proteins or iron dextran\n* Women of childbearing potential with positive serum HCG","ALL","18 Years",{"count":68,"type":69},21,"ESTIMATED","INTERVENTIONAL",[72],"NA","The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.",[75,76],"Graft Failure","Poor Graft Function","2025-09-23",{"date":79,"type":80},"2025-09-29","ACTUAL",{"date":82,"type":80},"2024-10-31",{"date":84,"type":69},"2035-08",{"name":5,"class":6},1]