[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627760":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":26,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MSCs treatment group","EXPERIMENTAL","Human umbilical cord mesenchymal stem cells injection is a human expanded umbilical cord mesenchymal stem cells suspension",[13],"Biological: Human umbilical cord mesenchymal stem cells injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo-control group","PLACEBO_COMPARATOR","Saline solution",[19],"Other: saline solution",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Human umbilical cord mesenchymal stem cells injection","Pahse 1: Patients will be enrolled into one of three cohorts to receive single injection of human umbilical cord mesenchymal stem cells injection(5×10\\^5 cells × vascular surface area (cm²), 2.5×10\\^6 cells × vascular surface area (cm²), 5×10\\^6 cells × vascular surface area (cm²)).\n\nPhase 2: Based on the data obtained from Phase 1, the investigator will select one dose cohort to conduct study.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","saline solution","Phase 2: Saline solution will be given at the same quantity and following the same schedule",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Jianhua Dong","CONTACT","02580864326","dongjianhua007@126.com",{"type":39,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100627760","phase-1-safety-and-efficacy-study-of-human-umbilical-cord-mesenchymal-stem-cells-in-preventing-arteriovenous-fistula-stenosis-in-patients-with-end-stage-diabetic-kidney-disease-100627760",false,"NCT07452822","Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease","A Prospective, Open-label and Single-arm Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Diabetic nephropathy with estimated glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin·1.73m²;\n2. Requirement for creation of primary forearm cephalic vein-radial artery autologous arteriovenous fistula ;\n3. Vessel criteria: cephalic vein diameter ≥ 2.0 mm (after tourniquet inflation) and radial artery diameter ≥ 1.5 mm;\n4. Subject agrees to comply with the study treatment plan and visit schedule, is voluntarily enrolled, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;\n2. Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;\n3. Patients with a history of pacemaker implantation;\n4. Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;\n5. Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;\n6. Subjects who have participated in, are currently participating in, or plan to participate in other interventional clinical trials within 30 days prior to screening or during the study period;\n7. Any other conditions deemed inappropriate by the investigator for enrollment in this study.","ALL","18 Years","70 Years",{"count":51,"type":52},54,"ESTIMATED","INTERVENTIONAL",[55,56],"PHASE1","PHASE2","A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis",[59],"Arteriovenous Fistula Stenosis","NOT_YET_RECRUITING","2026-03-01",{"date":63,"type":64},"2026-03-05","ACTUAL",{"date":66,"type":52},"2026-02-20",{"date":68,"type":52},"2028-03-30",{"name":5,"class":6}]