[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606411":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":41,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":19,"overallStatus":65,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"UCB-MNCs","EXPERIMENTAL","UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation",[13],"Biological: UCB-MNCs",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Ji ZHU","CONTACT","0571-88128212","zhuji@zjcc.org.cn",[27],{"facility":5,"status":19,"city":28,"state":29,"zip":19,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Hangzhou","Zhejiang","China","CN",{"type":33,"coordinates":34},"Point",[35,36],120.16142,30.29365,{"lat":36,"lon":35},[39],{"name":40,"role":23,"phone":24,"phoneExt":19,"email":25},"Ji ZHU, MD",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Ji Zhu","Principal Investigator","100606411","early-phase-1-study-on-safety-and-efficacy-of-ucb-mncs-for-chronic-radiation-enteritis-100606411",false,"NCT07175207","Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis","Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Chronic Radiation Enteritis","Inclusion Criteria:\n\n1. Aged 18-75 years, with no restriction on gender;\n2. History of pelvic and abdominal radiotherapy;\n3. Patients diagnosed with chronic radiation-induced intestinal injury (CRII) via colonoscopy and pathological examination (≥3 months after the end of radiotherapy);\n4. Diagnosed with grade 2-3 radiation-induced intestinal injury based on the clinical symptom assessment (RTOG classification) in Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Radiation-Induced Intestinal Injury in China;\n5. Poor response to conventional treatment for two weeks, with symptoms showing no remission or progressive aggravation;\n6. Well-controlled tumor for ≥3 months;\n7. No significant abnormalities in liver and renal function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 2 times the upper limit of normal (ULN);\n8. Expected lifespan of the subject ≥ 3 months;\n9. The patient is informed of the study details and voluntarily signs the informed consent form;\n10. Willing and able to receive treatment and complete follow-up in accordance with the protocol requirements, and able to adhere to the doctor's advice for basic treatment.\n\nExclusion Criteria:\n\n1. Severe cardiac insufficiency (e.g., NYHA classification Grade Ⅲ or Ⅳ) and uncontrolled hypertension with medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg);\n2. Positive results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2;\n4. Currently participating in another clinical trial or having participated in another clinical trial within 4 weeks;\n5. Patients with an allergic diathesis or known allergy to the preparation used in this trial;\n6. Patients with comorbid mental illness who are unable to cooperate with treatment;\n7. Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":56,"type":57},10,"ESTIMATED","INTERVENTIONAL",[60],"EARLY_PHASE1","This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for chronic radiation enteritis (CRE) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating CRE.",[63,64],"Chronic Radiation Induced Intestinal Injury","Chronic Radiation Enteritis","NOT_YET_RECRUITING","2025-09-09",{"date":68,"type":69},"2025-09-16","ACTUAL",{"date":71,"type":57},"2025-10-01",{"date":73,"type":57},"2026-12-31",{"name":5,"class":6},1]