[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515004":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":50,"locations":60,"responsibleParty":80,"collaborators":83,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":32,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":32,"studyType":107,"phases":108,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":62,"whyStopped":32,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Control","PLACEBO_COMPARATOR","standard medical treatment+Placebo(5% human serum albumin in 0.9% saline, at week0, week1 and week2)",[13,14],"Drug: standard medical treatment","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Group MSC-1","EXPERIMENTAL","Patients received standard medical treatment and infusions of hUC-MSC(1.5×10\\^8) via peripheral veins once a week for 3 timess(at week0, week1, and week2).",[13,20],"Drug: hUC-MSC",{"label":22,"type":17,"description":23,"interventionNames":24},"Group MSC-2","Patients in Group MSC-1 received standard medical treatment and infusions of hUC-MSC(1.5×10\\^8) via peripheral veins once a week for another 2 timess(at week4 and week5).",[13,20,25],"Drug: hUC-MSC_Prolonged",[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","standard medical treatment","standard medical treatment for ACLF",[9,16,22],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Placebo","5% human serum albumin in 0.9% saline (at week0, week1 and week2)",[9],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"hUC-MSC","hUC-MSC (1.5×10\\^8 cells\u002Ftime, Peripheral IV, at week0, week1 and week2)",[16,22],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"hUC-MSC_Prolonged","hUC-MSC (1.5×10\\^8 cells\u002Ftime, Peripheral IV, at week4 and week5)",[22],[46],{"name":47,"affiliation":48,"role":49},"Ming Shi, PhD","the Fifth Medical Center, Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Tao Yang, MD","CONTACT","86-010-66933333","y_t_0321@163.com",{"name":57,"role":53,"phone":58,"phoneExt":32,"email":59},"Yanhu Wang, MM","86-010-66933328","2440477984@qq.com",[61],{"facility":48,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Beijing","Beijing Municipality","100039","China","CN",{"type":69,"coordinates":70},"Point",[71,72],116.39723,39.9075,{"lat":72,"lon":71},[75,77],{"name":52,"role":53,"phone":76,"phoneExt":32,"email":55},"010-66933333",{"name":78,"role":53,"phone":76,"phoneExt":32,"email":79},"Mengyao Li, MB","qianlimengyao@163.com",{"type":49,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Shi Ming","Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases",[84,87,89,91],{"name":85,"class":86},"Shulan (Hang Zhou) Hospital","UNKNOWN",{"name":88,"class":86},"BeijingYouan Hospital",{"name":90,"class":6},"Shenzhen Third People's Hospital",{"name":92,"class":93},"Shen Zhen Wingor Biotechnology CO. LTD","INDUSTRY","100515004","phase-1-human-umbilical-cord-mesenchymal-stem-cell-transplantation-for-the-treatment-of-acute-on-chronic-liver-failure-100515004",false,"NCT05985863","Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure","Clinical Research of Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure","Inclusion Criteria:\n\n1. 18 years old ≤ age ≤ 70 years old, gender is not limited.\n2. Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg\u002Fdl or more) and coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%） complicated within 4 weeks by clinical ascites, encephalopathy, or both.\n3. Willing to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;\n2. Before the onset of liver failure, the previous indicators of the patient included PLT\\\u003C50×10\\^9\u002FL or Child-Pugh score\\>9;\n3. Combined with liver cancer or other malignant tumors;\n4. Patients with previous liver transplantation or planned liver transplantation within 3 months;\n5. Severe organic disease of primary extrahepatic organs;\n6. Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;\n7. Pregnant, breastfeeding women or those who plan to have a baby in the near future;\n8. Those who are highly allergic or have a history of severe allergies;\n9. Those who have received immunosuppressant and immune enhancer treatment within 1 month;\n10. Drug abuse in the past 5 years;\n11. Alcohol withdrawal symptoms;\n12. A history of severe mental disorders within 24 months before screening, including uncontrolled major depression or controlled or uncontrolled psychosis;\n13. Those who have participated or are participating in other clinical trials within three months before screening, or have previously received stem cell therapy;\n14. Other conditions that the investigator thinks that the patient is not suitable to participate in this study.","ALL","18 Years","70 Years",{"count":105,"type":106},150,"ESTIMATED","INTERVENTIONAL",[109,110],"PHASE1","PHASE2","This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.",[113],"Acute-On-Chronic Liver Failure",[115,113,116],"Mesenchymal Stem Cells","Therapeutics","2024-05-06",{"date":119,"type":120},"2024-05-07","ACTUAL",{"date":122,"type":120},"2023-09-30",{"date":124,"type":106},"2028-12-30",{"name":5,"class":6},1]