[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549804":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open label single arm study","EXPERIMENTAL","All patients will receive a single injection of umbilical cord-derived mesenchymal stem cells (120 million cells), and their therapeutic response will be monitored over a period of 24 months.",[13],"Biological: Mesenchymal Stem Cells (MSCs)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Mesenchymal Stem Cells (MSCs)","MSC suspension single does injection.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Zhaoshen Li, MD","CONTACT","021-81873241","zhsl@vip.163.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Jinling Hospital","RECRUITING","Nanjing","Jiangsu","210016","China","CN",{"type":37,"coordinates":38},"Point",[39,40],118.77778,32.06167,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Haoyu Xu, BD","19895883608","quanguorenmin1994@163.com",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100549804","phase-1-umbilical-cord-derived-mesenchymal-stem-cells-injection-for-chronic-radiation-proctitis-100549804",false,"NCT06438809","Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis","Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis","Inclusion Criteria:\n\n1. Fully understand and sign the informed consent form;\n2. Age ≥18 years and \\\u003C80 years;\n3. Good physical condition (WHO performance status score 0-1);\n4. Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;\n5. Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;\n6. Screening period LENT-SOMA score ≥1;\n7. Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.\n\nExclusion Criteria:\n\n1. Patients with severe liver or kidney dysfunction during the screening period;\n2. Patients with severe congestive heart failure or coronary artery disease during the screening period;\n3. Patients with allergic constitution or severe systemic immune diseases;\n4. Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;\n5. Pregnant patients;\n6. Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;\n7. Patients with a screening period LENT-SOMA score of 4;\n8. Patients with tumor recurrence or metastasis;\n9. Patients currently participating in other clinical trials at the time of screening or who have not been out of another clinical trial for less than 1 month;\n10. Other situations deemed unsuitable for inclusion in this study by the investigator.","ALL","18 Years","79 Years",{"count":60,"type":61},24,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","A Phase I\u002FII study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.",[68],"Chronic Radiation Proctitis","2024-06-20",{"date":71,"type":72},"2024-06-21","ACTUAL",{"date":74,"type":72},"2024-05-24",{"date":76,"type":61},"2025-05",{"name":5,"class":6},1]