[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654246":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":64,"studyPopulation":64,"armGroups":76,"interventions":89,"overallOfficials":100,"centralContacts":107,"locations":117,"responsibleParty":135,"collaborators":138,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":64,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":64,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":120,"whyStopped":64,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Dr Cipto Mangunkusumo General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":64},[9],{"measure":10,"description":11,"timeFrame":12},"Total Bilirubin Level","Measurement of total bilirubin level","Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180",[14,17,20,23,25,28,31,34,37,40,43,46,50,53,56,60],{"measure":15,"description":16,"timeFrame":12},"Direct Bilirubin Level","Measurement of direct bilirubin level",{"measure":18,"description":19,"timeFrame":12},"Indirect Bilirubin Level","Measurement of indirect bilirubin levels",{"measure":21,"description":22,"timeFrame":12},"AST (Aspartate Transaminase) Levels","Hepatocellular injury marker",{"measure":24,"description":22,"timeFrame":12},"ALT(Alanine Transaminase) Levels",{"measure":26,"description":27,"timeFrame":12},"Gamma-glutamyl Transferase (GGT)","Cholestasis marker",{"measure":29,"description":30,"timeFrame":12},"Serum Albumin Level","Marker of liver synthesis function and nutrition status",{"measure":32,"description":33,"timeFrame":12},"Prothrombin Time (PT), INR","Coagulation parameter to assess liver synthesis function",{"measure":35,"description":36,"timeFrame":12},"Complete Blood Count","Hematology panel including hemoglobin, leukocyte count, platelet count, absolute neutrophil count (ANC), and hematocrit.",{"measure":38,"description":39,"timeFrame":12},"Pediatric End-Stage Liver Disease-Creatinine (PELD-Cr) Score","The Pediatric End-Stage Liver Disease-Creatinine (PELD-Cr) score is used to assess liver disease severity and estimate mortality risk in pediatric patients with end-stage liver disease. In accordance with Organ Procurement and Transplantation Network (OPTN) policy, the minimum score for this scale is capped at 6 (any calculated laboratory score below 6 is reported as 6), and there is no upper limit or maximum score. Higher PELD-Cr scores indicate greater liver disease severity and a worse clinical prognosis.",{"measure":41,"description":42,"timeFrame":12},"Jaundice Clearance","Postoperative jaundice resolution, assessed through clinical evaluation and total\u002Fdirect serum bilirubin levels.",{"measure":44,"description":45,"timeFrame":12},"Liver Fibrosis Stages","Evaluated by measuring liver stiffness via Acoustic Radiation Force Impulse (ARFI) ultrasound, mapped to the METAVIR Fibrosis Staging Scale. The scale ranges from a minimum score of 0 (F0: no fibrosis) to a maximum score of 4 (F4: cirrhosis). Higher scores indicate greater liver fibrosis severity and a worse clinical outcome.",{"measure":47,"description":48,"timeFrame":49},"Regulatory T-cell (Treg) levels","Regulatory T-cell (Treg) levels as an immunological parameter, measured postoperatively using flow cytometry and reported in standard laboratory units.","Post-Operative Day 7",{"measure":51,"description":52,"timeFrame":49},"CD11c Levels","CD11c-positive immune cell marker levels, measured postoperatively via flow cytometry and reported in standard laboratory units.",{"measure":54,"description":55,"timeFrame":12},"Postoperative Cholangitis Incidence","Incidence of postoperative cholangitis, diagnosed based on clinical symptoms, physical examination, and supporting diagnostic tests as evaluated by the attending physician.",{"measure":57,"description":58,"timeFrame":59},"Length of Stay","Calculated as the number of consecutive days from the date of surgery to the date of initial hospital discharge or in-hospital death during the index hospitalization. Re-admissions following initial discharge are excluded.","From the date of surgery until initial hospital discharge or death during the same period of care with the surgery, whichever occurs first (assessed up to 12 months).",{"measure":61,"description":62,"timeFrame":63},"All-Cause Mortality","Evaluated as the incidence of death from any cause occurring during the study period. Cause of death are verified through electronic medical record documentation, official death certificates, or direct patient\u002Ffamily follow-up contact.","From the date of study enrollment until death, assessed up to 12 months.",null,{"allocation":66,"interventionModel":67,"interventionModelDescription":64,"primaryPurpose":68,"observationalModel":64,"timePerspective":64,"maskingInfo":69},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":70,"maskingDescription":64,"whoMasked":71},"QUADRUPLE",[72,73,74,75],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[77,84],{"label":78,"type":79,"description":80,"interventionNames":81},"UC-MSC Group","EXPERIMENTAL","Infants aged 30-90 days with intraoperative cholangiography-confirmed biliary atresia undergoing Kasai portoenterostomy receive intraoperative intraparenchymal injections of umbilical cord-derived mesenchymal stem cells (UC-MSCs) across hepatic segments 3, 4, 5, and 6, at a target dose of 10\\^5 cells\u002Fkg (prepared in a 1 mL syringe at a concentration of 10\\^5 cells\u002F0.1 mL in 0.9% NaCl)",[82,83],"Biological: Umbilical Cord-Mesenchymal Stem Cells (UC-MSC)","Procedure: Kasai Portoenterostomy",{"label":85,"type":86,"description":87,"interventionNames":88},"Placebo Group","PLACEBO_COMPARATOR","Infants aged 30-90 days with intraoperative cholangiography-confirmed biliary atresia undergoing Kasai portoenterostomy receive intraoperative intraparenchymal injections of a placebo solution (prepared in a 1 mL syringe containing 0.9% normal saline) across hepatic segments 3, 4, 5, and 6.",[83],[90,95],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":64},"BIOLOGICAL","Umbilical Cord-Mesenchymal Stem Cells (UC-MSC)","Intraoperative intraparenchymal injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) at a dose of 10\\^5cells\u002Fkg, administered via a 1 mL syringe containing UC-MSCs at a concentration of 10\\^5 cells\u002F0.1mL in 0.9% NaCl, distributed across hepatic segments 3, 4, 5, and 6 in both liver lobes",[78],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":64},"PROCEDURE","Kasai Portoenterostomy","Standard surgical resection of extrahepatic biliary remnants with a Roux-en-Y portoenterostomy to restore bile drainage in biliary atresia patients",[85,78],[101,105],{"name":102,"affiliation":103,"role":104},"Radiana Dhewayani Antarianto, MD, M.Biomed, PhD","University of Indonesia, Cipto Mangunkusumo Hospital","PRINCIPAL_INVESTIGATOR",{"name":106,"affiliation":103,"role":104},"Fatima Safira Alatas, MD, PhD",[108,113],{"name":109,"role":110,"phone":111,"phoneExt":64,"email":112},"Tri Hening Rahayatri, MD, PhD","CONTACT","+62 816 1381 223","rahayatri@gmail.com",{"name":114,"role":110,"phone":115,"phoneExt":64,"email":116},"Irene Effendy, MD","+62 851 5891 6100","databasebped@gmail.com",[118],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Cipto Mangunkusumo Hospital","RECRUITING","Jakarta Pusat","DKI Jakarta","10430","Indonesia","ID",{"type":127,"coordinates":128},"Point",[129,130],106.8223,-6.1818,{"lat":130,"lon":129},[133,134],{"name":109,"role":110,"phone":111,"phoneExt":64,"email":112},{"name":114,"role":110,"phone":115,"phoneExt":64,"email":116},{"type":104,"investigatorFullName":136,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Tri Hening Rahayatri","Pediatric Surgeon, Head of Pediatric Surgery Division, MD, PhD, Principal Investigator",[139],{"name":140,"class":141},"PT. Kimia Farma (Persero) Tbk","INDUSTRY","100654246","phase-1-umbilical-cord-mesenchymal-stem-cell-therapy-for-biliary-atresia-100654246",false,"NCT07797673","Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia","Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia: A Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Pediatric patients aged 30 to 90 days.\n* Suspected biliary atresia based on clinical evaluation and diagnostic workup.\n* Biliary atresia diagnosis confirmed by intraoperative cholangiography.\n* Undergoing Kasai portoenterostomy at Cipto Mangunkusumo Hospital.\n* Written informed consent provided by a parent or legally authorized representative.\n\nExclusion Criteria:\n\n* Presence of congenital heart disease.\n* Diagnosis of Down syndrome.\n* Diagnoses other than biliary atresia confirmed by intraoperative cholangiography (e.g., choledochal cyst)\n\nDrop-out Criteria:\n\n\\- Subjects will be dropped from the study if they develop postoperative anastomotic leakage","ALL","30 Days","90 Days",{"count":153,"type":154},40,"ESTIMATED","INTERVENTIONAL",[157],"PHASE1","Biliary atresia is a progressive liver disease in infants where liver transplantation is often the only long-term option once cirrhosis develops. However, organ shortages, high costs, risks of graft rejection, and the need for lifelong immunosuppression make transplantation difficult for many families. This double-blind randomized clinical trial evaluates whether injecting umbilical cord-mesenchymal stem cells directly into the liver during Kasai portoenterostomy is safe and effective as an additional treatment. Umbilical cord stem cells have strong anti-inflammatory and anti-fibrotic properties, and they carry a low risk of immune rejection. Patients undergoing the Kasai procedure are randomly assigned to receive either direct intrahepatic stem cell injections or a placebo. Participants are followed for 180 days post-surgery to monitor safety, liver function, and changes in liver stiffness.",[160,161,162,163,164],"Biliary Atresia","Kasai Operation","Liver Fibrosis","Stem Cell","Liver Function Failure",[160,166,167,168,169,170,171],"Kasai portoenterostomy","Umbilical cord mesenchymal stem cell","UC-MSC","Liver fibrosis","Regenerative therapy","Double-blind randomized controlled trial","2026-09-04",{"date":174,"type":175},"2026-09-09","ACTUAL",{"date":177,"type":175},"2026-09-01",{"date":179,"type":154},"2028-12",{"name":5,"class":6},1]