[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-radiation-enteritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-radiation-enteritis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Chronic Radiation Induced Intestinal Injury","Chronic Radiation Enteritis","NOT_YET_RECRUITING","2025-09-09",{"date":32,"type":33},"2025-09-16","ACTUAL",{"date":35,"type":21},"2025-10-01",{"date":37,"type":21},"2026-12-31",{"name":39,"class":40},"Zhejiang Cancer Hospital","OTHER"]