[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100388414":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":53,"collaborators":32,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":32,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":32,"maxAge":65,"enrollmentInfo":66,"targetDuration":32,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":32,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients receiving allogeneic hematopoietic cell transplant","EXPERIMENTAL","The test product is a stem cell product which has been alpha-beta T- cell depleted using the CliniMACS system. Alpha-beta T-cell depleted cells are given intravenously over a period of time as dictated by the final volume of the infused product (5 ml\u002Fkg\u002Fhour).\n\nThe target dose of CD34+ cells is ≥20x10\\^6\u002Fkg, but a minimum of\n\n≥2.5x10\\^6\u002Fkg is required. The target dose of T-cell receptor (TCR) alpha-beta CD3+ cells is ≤1x10\\^5\u002Fkg.",[13],"Device: CliniMacs®",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","CliniMacs®","CliniMACS® CD34 Reagent System is now indicated for processing hematopoietic progenitor cells collected by apheresis (PBSC) from an allogeneic, HLA-identical MSD to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional GVHD prophylaxis in patients with AML in first morphologic complete remission (CR1).",[9],[21],"CliniMACS® CD34 Reagent System",[23],{"name":24,"affiliation":25,"role":26},"Christopher C Dvorak, MD","Professor of Clinical Pediatrics","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Christopher C. Dvorak, MD","CONTACT","415-476-0554",null,"christopher.dvorak@ucsf.edu",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","San Francisco","California","94143","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-122.41942,37.77493,{"lat":46,"lon":45},[49,52],{"name":24,"role":30,"phone":50,"phoneExt":32,"email":51},"877-827-3222","cancertrials@ucsf.edu",{"name":24,"role":26,"phone":32,"phoneExt":32,"email":32},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Christopher Dvorak","Professor of Pediatrics","100388414","a-feasibility-study-using-clinimacs-for-alphabeta-t-cell-depletion-in-stem-cell-transplant-100388414",false,"NCT04337515","A Feasibility Study Using CLINIMACS® for Alpha\u002FBeta T-Cell Depletion in Stem Cell Transplant","A Feasibility Study of Using the CiniMacs® Device for Alpha\u002FBest T-Cell Depletion in Stem Cell Transplant Recipients","Inclusion Criteria:\n\n* Male or female 0-30 years of age at time of transplant admission\n* Documentation of a disease requiring HCT\n* A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data\n* Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).\n* Patient with an anticipated life expectancy of \\\u003C1 month\n* Patients with known hypersensitivity to murine (mouse) proteins or iron dextran","ALL","30 Years",{"count":67,"type":68},90,"ESTIMATED","INTERVENTIONAL",[71],"NA","Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.",[74,75],"Graft Vs Host Disease","Graft-versus-host-disease","2026-04-06",{"date":78,"type":79},"2026-04-13","ACTUAL",{"date":81,"type":79},"2019-12-19",{"date":83,"type":68},"2035-01-01",{"name":55,"class":6},1]