[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100358144":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":97,"collaborators":100,"id":105,"slug":20,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":20,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":20,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined kidney\u002Fstem cell transplants and recipient's Tregs","EXPERIMENTAL","Preparatory regimen including TLI, TBI, ATG after kidney transplantation followed by infusion of donor CD34+, T cell and recipient Tregs",[13],"Biological: Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs","Living donor kidney transplant recipients will receive after a preparatory regimen of total lymphoid irradiation, total body irradiation and anti-thymocyte globulin an infusion of purified donor CD34+ of \\>10 x10\\^6 cells \u002FKg, 100 x 10\\^6 donor T cell\u002F Kg and and an escalated dose of recipient Tregs starting at 25 x10\\^6\u002FKg.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Everett Meyer, MD","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Kevin Ly, BS","CONTACT","650-497-6057","kevinly@stanford.edu",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Stephan Busque, MD","650-498-6189","sbusque@stanford.edu",[36,71],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Palo Alto","California","94305","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-122.14302,37.44188,{"lat":47,"lon":46},[50,54,55,57,60,62,64,66,67,69],{"name":51,"role":28,"phone":52,"phoneExt":20,"email":53},"Renata Gilfanova","650-736-0245","Rgilfan@stanford.edu",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"name":23,"role":56,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":20,"phoneExt":20,"email":20},"Robert Lowsky, MD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":20,"phoneExt":20,"email":20},"Richard Hoppe, MD",{"name":63,"role":59,"phone":20,"phoneExt":20,"email":20},"John Scandling, MD",{"name":65,"role":59,"phone":20,"phoneExt":20,"email":20},"Kent Jensen, PhD",{"name":32,"role":56,"phone":20,"phoneExt":20,"email":20},{"name":68,"role":59,"phone":20,"phoneExt":20,"email":20},"Colin Lenihan, MD",{"name":70,"role":59,"phone":20,"phoneExt":20,"email":20},"Thomas Pham, MD",{"facility":72,"status":37,"city":73,"state":74,"zip":75,"country":41,"countryCode":42,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Nothwestern University","Chicago","Illinois","60611",{"type":44,"coordinates":77},[78,79],-87.65005,41.85003,{"lat":79,"lon":78},[82,86,90,92,94,96],{"name":83,"role":28,"phone":84,"phoneExt":20,"email":85},"Leah Goudy, RN","312-694-0242","leah.goudy@northwestern.edu",{"name":87,"role":28,"phone":88,"phoneExt":20,"email":89},"Joseph Leventhal, MD","312-695-8900","jleventh@nm.org",{"name":91,"role":59,"phone":20,"phoneExt":20,"email":20},"Jayesh Mehta, MD",{"name":93,"role":59,"phone":20,"phoneExt":20,"email":20},"James Mathew, PhD",{"name":95,"role":59,"phone":20,"phoneExt":20,"email":20},"Lorenzo Gallon, MD",{"name":87,"role":56,"phone":20,"phoneExt":20,"email":20},{"type":56,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Stephan Busque","Professor of Surgery",[101,103],{"name":102,"class":6},"California Institute for Regenerative Medicine (CIRM)",{"name":104,"class":6},"Northwestern University","100358144",false,"NCT03943238","TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation","Phase 1 Study of Total Lymphoid Irradiation, Total Body Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+, T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation","Inclusion Criteria:\n\n1. All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.\n2. Patients who agree to participate in the study and sign an Informed Consent.\n3. Patients who have no known contraindication to administration of rabbit ATG or radiation.\n4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant\n\nExclusion Criteria:\n\n1. Previous treatment with rabbit ATG or a known allergy to rabbit proteins.\n2. History of malignancy with the exception of non-melanoma skin malignancies.\n3. Pregnant women or nursing mothers.\n4. Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.\n5. Leukopenia (with a white blood cell count \\\u003C 3000\u002Fmm3) or thrombocytopenia (with a platelet count \\\u003C 100,000\u002Fmm3).\n6. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and\u002For current donor specific antibody (DSA)\n7. Prior organ transplantation\n8. High risk of primary kidney disease recurrence\n9. Advanced coronary or vascular disease.","ALL","18 Years","65 Years",{"count":115,"type":116},22,"ESTIMATED","INTERVENTIONAL",[119],"PHASE1","This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.",[122],"Living Donor Kidney Transplantation",[124,125,126,127],"kidney transplant","Immunological Tolerance","Tregs","Stem cells","2026-06-29",{"date":130,"type":131},"2026-07-01","ACTUAL",{"date":133,"type":131},"2020-02-01",{"date":135,"type":116},"2029-12-01",{"name":5,"class":6},2]