[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512171":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":31,"collaborators":19,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":19,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":19,"studyType":46,"phases":47,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":55,"whyStopped":19,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":19},{"fullName":5,"class":6},"Asia Cell Therapeutics (Shanghai) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Human Umbilical Cord Mesenchymal Stem Cells","EXPERIMENTAL","The trial was divided into three dose groups： Low-dose group: 1000000 cells\u002Fkg Medium-dose group: 2000000 cells\u002Fkg High-does group: 4000000 cells\u002Fkg",[13],"Biological: Human Umbilical Cord Mesenchymal Stem Cells",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","The stem cell infusion route is peripheral intravenous infusion, once every 4 weeks for a total of 3 infusions. All subjects received experimental drugs and conventional treatment during the study period.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Lungen Lu, MD","Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Wenli Liu","CONTACT","+86 13402137712","liuwenli@xibaozhiliao.cn",{"type":32,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100512171","phase-1-safety-of-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-patients-with-decompensated-hepatitis-b-cirrhosis-100512171",false,"NCT05948982","Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis","A Clinical Trial to Evaluate the Safety, Tolerance and Efficacy of aCell Inj. of Allogeneic UC-MSCs in Patients With Decompensated Hepatitis B Cirrhosis","Inclusion Criteria:\n\n* 18 to 75 years old (including borderline values) at screening, regardless of gender\n* Diagnosed with decompensated hepatitis B cirrhosis according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition)\n* There's no significant reduction in cirrhotic symptoms or no significant improvement in quality of life score after more than 3 months of strict medical conservative treatment\n* HBV DNA ≤ 1000 IU\u002FmL at the time of screening\n* Fully understand the informed consent form, voluntarily subject to the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* other causes of cirrhosis, such as alcoholic hepatitis, viral hepatitis C, autoimmune hepatitis and metabolic-related fatty liver disease\n* Child-Pugh score \\>12;\n* History of malignancy of the liver or other organs, or a family history of liver malignancy in three generations of immediate family members;\n* Current serious medical conditions that would affect your safety and treatment efficacy assessment as determined by the investigator, such as: Class II or higher abnormal cardiac function (NYHA criteria), cardiovascular disease such as ischemic heart disease (e.g., myocardial infarction or angina), poorly controlled diabetes (fasting glucose ≥ 10 mmol\u002FL or glycated hemoglobin (HbA1c) ≥ 8%), serum creatinine \\> 2 times the upper limit of normal (ULN), etc;\n* Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically significant upper gastrointestinal hemorrhage event within 4 weeks prior to screening), as determined by the investigator to be unsuitable for participation in this trial;\n* Have had hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening\n* Spontaneous peritonitis or a more severe active infection within 2 weeks prior to the trial\n* Positive infectious disease test (serum anti-HIV antibody, anti-HCV antibody, syphilis antibody either positive) or active tuberculosis;\n* Those who have received human albumin within 3 weeks prior to the first infusion of the test drug;\n* Those who have the history of venous thrombosis or pulmonary embolism\n* Drug addicted or alcohol abusers;\n* Women who are pregnant or breastfeeding;\n* Persons with a history of severe drug allergy or hypersensitivity;\n* History of a serious mental disorder, including uncontrolled major depression or controlled or uncontrolled psychosis, within 24 months prior to screening;\n* Those who have participated in other interventional clinical trials within 3 months prior to screening or are participating in other interventional clinical trials, or who have received prior stem cell therapy\n* Those who are proposed for liver transplantation within 3 months;\n* Other conditions that, in the opinion of the investigator, are not suitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":44,"type":45},18,"ESTIMATED","INTERVENTIONAL",[48,49],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with decompensated hepatitis B cirrhosis in the future.\n\nParticipants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.",[52],"Decompensated Liver Cirrhosis",[54,9],"Decompensated hepatitis B cirrhosis","NOT_YET_RECRUITING","2023-07-13",{"date":58,"type":59},"2023-07-17","ACTUAL",{"date":61,"type":45},"2023-07-30",{"date":63,"type":45},"2026-12-31",{"name":5,"class":6}]