[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593804":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":45,"locations":54,"responsibleParty":74,"collaborators":26,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":26,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":26,"overallStatus":100,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Universitas Diponegoro","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group (UC-MSC Group)","EXPERIMENTAL","Participants in this group are infants diagnosed with biliary atresia who undergo Kasai portoenterostomy before 90 days of age. During the operation, they receive intraoperative trans-portal vein injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) at a dose of 20 million cells diluted in 5 mL autologous plasma.",[13,14],"Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)","Procedure: Kasai Portoenterostomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group (Historical Control Group)","PLACEBO_COMPARATOR","Participants in this group are historical patients who previously underwent Kasai portoenterostomy before 90 days of age at the same institution but did not receive UC-MSC therapy. Data for this group is collected retrospectively.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)","Intraoperative trans-portal vein injection of 20 million mesenchymal stem cells derived from umbilical cord tissue, suspended in 5 mL autologous plasma.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Kasai Portoenterostomy","Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.",[16,9],[33,37,40,43],{"name":34,"affiliation":35,"role":36},"Avriana Pety Wardani, MD, Sp.BA","Dr. Kariadi General Hospital Medical Center","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":39},"Erik Prabowo, Dr, MD, M.Si.Med, Sp.B-KBD","STUDY_DIRECTOR",{"name":41,"affiliation":5,"role":42},"Kevin Christian Tjandra, MD","STUDY_CHAIR",{"name":44,"affiliation":5,"role":42},"Danendra Rakha Putra Respati, MD",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Avriana Pety Wardani, MD, Sp. BA","CONTACT","+62 81229515791","avrianagarg@gmail.com",{"name":41,"role":48,"phone":52,"phoneExt":26,"email":53},"+62 87700771775","kevinchristian2841@gmail.com",[55],{"facility":35,"status":26,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Semarang","Central Java","50244","Indonesia","ID",{"type":62,"coordinates":63},"Point",[64,65],110.42083,-6.99306,{"lat":65,"lon":64},[68,69,70,72,73],{"name":34,"role":48,"phone":49,"phoneExt":26,"email":50},{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"name":38,"role":71,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":41,"role":71,"phone":26,"phoneExt":26,"email":26},{"name":44,"role":71,"phone":26,"phoneExt":26,"email":26},{"type":36,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":35,"oldNameTitle":26,"oldOrganization":26},"Avriana Pety Wardani","MD, Sp. BA","100593804","phase-1-clinical-outcomes-of-early-kasai-surgery-with-umbilical-cord-mscs-in-biliary-atresia-100593804",false,"NCT07011199","Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia","Evaluation of Clinical Outcomes in Biliary Atresia Patients Undergoing Kasai Surgery Before 90 Days of Age With Umbilical Cord-Derived Mesenchymal Stem Cell Therapy","Inclusion Criteria:\n\n* Infants diagnosed with biliary atresia confirmed by intraoperative findings.\n* Underwent Kasai portoenterostomy at an age less than 90 days.\n* Parents or legal guardians have provided informed consent to participate in the study and follow all study procedures.\n\nExclusion Criteria:\n\n* Infants with severe malnutrition.\n* Infants with major congenital anomalies other than biliary atresia.\n* Infants with positive tumor markers.","ALL","0 Days","90 Days",{"count":88,"type":89},14,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","The goal of this clinical trial with historical control is to evaluate whether umbilical cord-derived mesenchymal stem cell (UC-MSC) therapy can improve clinical outcomes in infants with biliary atresia undergoing Kasai surgery before 90 days of age.\n\nThe main questions it aims to answer are:\n\nDoes UC-MSC therapy improve liver function parameters (bilirubin, albumin, liver enzymes, coagulation profile)? Does UC-MSC therapy reduce complications such as anemia, ascites, jaundice, and improve PELD scores? Does UC-MSC therapy improve overall survival compared to standard Kasai surgery alone? Researchers will compare the group receiving UC-MSC in 2025-2027 with a historical control group of patients who previously underwent Kasai surgery without UC-MSC therapy.\n\nParticipants will:\n\nUndergo preoperative evaluation, including laboratory and imaging tests. Receive Kasai surgery combined with intraoperative trans-portal vein injection of 20 million UC-MSCs.\n\nBe monitored postoperatively through serial laboratory tests, imaging (Fibroscan), and clinical assessments at scheduled intervals.\n\nBe followed up for potential serious adverse events and survival outcomes.",[95,29,96,97,98,99],"Biliary Atresia","Mesenchymal Stem Cell Transplantation","Liver Function Disorders","Liver Fibrosis","Survival Rate","NOT_YET_RECRUITING","2025-05-30",{"date":103,"type":104},"2025-06-08","ACTUAL",{"date":106,"type":89},"2025-06-17",{"date":108,"type":89},"2026-04-17",{"name":5,"class":6},1]