[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr Cipto Mangunkusumo General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Biliary Atresia","Kasai Operation","Liver Fibrosis","Stem Cell","Liver Function Failure",[27,33,34,35,36,37,38],"Kasai portoenterostomy","Umbilical cord mesenchymal stem cell","UC-MSC","Liver fibrosis","Regenerative therapy","Double-blind randomized controlled trial","RECRUITING","2026-09-04",{"date":42,"type":43},"2026-09-09","ACTUAL",{"date":45,"type":43},"2026-09-01",{"date":47,"type":21},"2028-12",{"name":49,"class":50},"Dr Cipto Mangunkusumo General Hospital","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":51},"100519512","phase-1-autologous-natural-killer-cell-therapy-for-hepatocellular-carcinoma-100519512","NCT06044506","Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma","A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Patients aged 20-60 years old\n* Patients with Hepatocellular Carcinoma (HCC) staged as BCLC B and C\n* Karnofsky Performance Status (KPS) score ≥ 70\n* Expected patient survival of more than three months\n* The following parameters are within the normal range:\n\nPlatelet count ≥ 80,000\u002FµL White blood cell count ≥ 3000\u002FµL Neutrophil count ≥ 2000 Hemoglobin ≥ 9 mg\u002FdL International Normalized Ratio (INR) 0.8-1.5 Adequate liver function (bilirubin \\\u003C 2, SGOT and SGPT \\\u003C 60 U\u002FL) Adequate kidney function (serum creatinine \\\u003C 1.3, serum urea \\\u003C 10)\n\nExclusion Criteria:\n\n* Refusing to participate in the study\n* Afflicted by other malignancies, whether non-HCC liver or other malignancies\n* Patients are affected by other conditions such as hypertension, severe coronary disease, myelosuppression, respiratory disorders, and acute or chronic infections\n* Patients who have previously undergone transplantation and received other stem cell therapies","20 Years","60 Years",{"count":62,"type":21},3,[24],"This study represents a phase I clinical trial that utilizes natural killer (NK) cell therapy for patients diagnosed with liver cancer, specifically those classified as Child-Pugh A and falling within the Barcelona Clinic Liver Cancer (BCLC) stages B or C. The expected results include determining the suitable treatment dosage, identifying any resulting side effects, and calculating the average duration of progression-free survival. The target group for the study consists of all individuals diagnosed with liver cancer. At the same time, the practical sample consists of those who received medical care for liver cancer at Cipto Mangunkusumo Hospital (RSCM) between May and December 2022. The chosen research sample comprises liver cancer patients who fulfill the predetermined participation criteria. The necessary sample size for discerning appropriate treatment dosages and the occurrence rate of potential side effects shall consist of 2-3 liver cancer patients who are administered autologous NK cells. The process for isolating these NK cells adheres to the guidelines established by Miltenyi Biotec.",[66],"Hepatocellular Carcinoma",[68,69,66],"Natural Killer Cell","Immunotherapy","2023-09-24",{"date":72,"type":43},"2023-09-26",{"date":74,"type":43},"2022-08-29",{"date":76,"type":21},"2026-12",{"name":49,"class":50},""]