[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581616":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":123,"collaborators":20,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":20,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":20,"overallStatus":144,"whyStopped":20,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Fundacion Clinic per a la Recerca Biomédica","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.\n\nPatients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).\n\n* 30 highly sensitized patients will be pre-included in the study.\n* The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will receive study treatment.",[13],"Biological: Autologous Tolerogenic Dendritic Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Autologous Tolerogenic Dendritic Cells","• Autologous Tolerogenic Dendritic Cells (D+1 to D+3 post-transplantation), ATDC, 1 million ATDC\u002FKg over a period of 30 minutes (up to 1 hour) will administer between Day 1 and Day 3 after transplantation.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Fritz Diekmann, Dr","CONTACT","+34932775444","fdiekman@clinic.cat",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Maria Joyera","+34932775400","joyera@recerca.clinic.cat",[32,50,63,74,85,95,109],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hospital Germans Trias i Pujol","Badalona","Barcelona","08916","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],2.24741,41.45004,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":48,"phoneExt":20,"email":49},"Anna Vila Santandreu","+34934978898","annavilas.germanstrias@gencat.cat",{"facility":51,"status":20,"city":35,"state":35,"zip":52,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Hospital del Mar","08003",{"type":40,"coordinates":54},[55,56],2.15899,41.38879,{"lat":56,"lon":55},[59],{"name":60,"role":24,"phone":61,"phoneExt":20,"email":62},"Marta Crespo Barrio","+34932483689","mcrespo@psmar.cat",{"facility":64,"status":20,"city":35,"state":35,"zip":65,"country":37,"countryCode":38,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Fundació Puigvert","08025",{"type":40,"coordinates":67},[55,56],{"lat":56,"lon":55},[70],{"name":71,"role":24,"phone":72,"phoneExt":20,"email":73},"Carme Facundo","+34934169700","cfacundo@fundacio-puigvert.es",{"facility":75,"status":20,"city":35,"state":35,"zip":76,"country":37,"countryCode":38,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Hospital Vall d'Hebron","08035",{"type":40,"coordinates":78},[55,56],{"lat":56,"lon":55},[81],{"name":82,"role":24,"phone":83,"phoneExt":20,"email":84},"Francesc Josep Moreso Mateos","+34932746000","francescjosep.moreso@vallhebron.cat",{"facility":86,"status":20,"city":35,"state":35,"zip":87,"country":37,"countryCode":38,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Hospital Clinic Barcelona","08036",{"type":40,"coordinates":89},[55,56],{"lat":56,"lon":55},[92],{"name":93,"role":24,"phone":94,"phoneExt":20,"email":26},"Fritz Diekmann","+34932275444",{"facility":96,"status":20,"city":97,"state":35,"zip":98,"country":37,"countryCode":38,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Hospital Universitari Bellvitge","L'Hospitalet de Llobregat","08907",{"type":40,"coordinates":100},[101,102],2.10028,41.35967,{"lat":102,"lon":101},[105],{"name":106,"role":24,"phone":107,"phoneExt":20,"email":108},"Edoardo Melilli","+34932607385","emelilli@bellvitgehospital.cat",{"facility":110,"status":20,"city":111,"state":111,"zip":112,"country":37,"countryCode":38,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Hospital Universitario Miguel Servet","Zaragoza","50009",{"type":40,"coordinates":114},[115,116],-0.87734,41.65606,{"lat":116,"lon":115},[119],{"name":120,"role":24,"phone":121,"phoneExt":20,"email":122},"Alex Gutiérrez Dalmau","+34976765500","alexgutierrezd@gmail.com",{"type":124,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100581616","phase-1-autologous-tolerogenic-dendritic-cells-atdc-for-highly-sensitized-kidney-transplant-recipients-100581616",false,"NCT06852625","Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients","ATDC-PICI","Inclusion Criteria:\n\n1. Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.\n2. To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.\n3. Adequate venous access and absence of contraindications for leukoapheresis.\n4. Women of childbearing age must take contraceptive measures.\n5. Must have given written informed consent\n\nExclusion Criteria:\n\n1. Subjects with active TB.\n2. Patients on the waiting list multiple organ transplants.\n3. A significantly abnormal general serum screening lab result defined as WBC\\\u003C3.0x103\u002Fml, Hgb\\\u003C8.0 g\u002FdL, platelet count \\\u003C100x103\u002Fml, SGOT\\>3x upper limit.\n4. HIV-positive subjects.\n5. Subjects who test positive for HBV infection \\[positive HBVsAg or HBVeAg\u002FDNA\\] or HCV infection \\[RNA+\\].\n6. Subjects with active CMV or EBV infection as defined by positive PCR.\n7. Subjects with a known history of previous myocardial infarction within one year of screening.\n8. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.\n9. Patients with a kidney disease with high risk of recurrence and\u002For complement-associated kidney disease (aHUS, etc).\n10. Pregnant and lactating women.","ALL","18 Years","65 Years",{"count":136,"type":137},30,"ESTIMATED","INTERVENTIONAL",[140],"PHASE1","The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.",[143],"Kidney Transplant Rejection","NOT_YET_RECRUITING","2025-02-24",{"date":147,"type":148},"2025-02-28","ACTUAL",{"date":150,"type":137},"2025-05",{"date":152,"type":137},"2028-03",{"name":5,"class":6},7]