[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606411":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":27,"studyPopulation":27,"armGroups":39,"interventions":46,"overallOfficials":27,"centralContacts":51,"locations":57,"responsibleParty":72,"collaborators":27,"id":76,"slug":27,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":27,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":27,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":27,"overallStatus":95,"whyStopped":27,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline Vienna Rectoscopy Score (VRS)","The VRS evaluates four core endoscopic features (mucosal hyperemia\u002Ferythema, mucosal ulceration, mucosal fibrosis\u002Fstenosis, and telangiectasia), with each feature scored on a 0-3 scale (0 = no abnormality, 3 = severe abnormality). The total VRS score is the sum of scores from the four features, typically ranging from 0 to 12. The total score directly reflects the severity of radiation-induced intestinal injury.","At 3 and 12 months after the last treatment.",[14,18,22,25,29],{"measure":15,"description":16,"timeFrame":17},"Clinical remission rate","Symptoms such as hematochezia and diarrhea will be counted before treatment and at 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment. The corresponding symptom remission rate will be calculated by comparing with the pre-treatment status.","At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.",{"measure":19,"description":20,"timeFrame":21},"Change from baseline LENT-SOMA scoring scale","LENT-SOMA uses a 0-4 grading system for each of the four dimensions (subjective, objective, management, analytic), with scores directly reflecting the severity of radiation-induced tissue injury. A higher LENT-SOMA grade indicates more severe radiation-induced tissue damage.","At 3 months and 12 months after the last treatment.",{"measure":23,"description":24,"timeFrame":17},"Change from baseline visual analog scale (VAS)","VAS is a simple tool to measure pain extent: it uses a 10-centimeter horizontal line, with \"no pain at all\" marked at 0 and \"worst pain imaginable\" at 10. Patients mark a point matching their current pain.",{"measure":26,"description":27,"timeFrame":28},"Hemoglobin concentration",null,"Changes in hemoglobin levels will be compared before treatment and at 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.",{"measure":30,"description":31,"timeFrame":32},"Changes in Intestinal Flora Distribution","Intestinal flora distribution specifically describes the composition, quantity, and proportional balance of the microbial species.","At 1 week and 1 month after the last treatment.",{"allocation":34,"interventionModel":35,"interventionModelDescription":27,"primaryPurpose":36,"observationalModel":27,"timePerspective":27,"maskingInfo":37},"NA","SINGLE_GROUP","TREATMENT",{"masking":38,"maskingDescription":27,"whoMasked":27},"NONE",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"UCB-MNCs","EXPERIMENTAL","UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation",[45],"Biological: UCB-MNCs",[47],{"type":48,"name":41,"description":49,"armGroupLabels":50,"otherNames":27},"BIOLOGICAL","UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.",[41],[52],{"name":53,"role":54,"phone":55,"phoneExt":27,"email":56},"Ji ZHU","CONTACT","0571-88128212","zhuji@zjcc.org.cn",[58],{"facility":5,"status":27,"city":59,"state":60,"zip":27,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Hangzhou","Zhejiang","China","CN",{"type":64,"coordinates":65},"Point",[66,67],120.16142,30.29365,{"lat":67,"lon":66},[70],{"name":71,"role":54,"phone":55,"phoneExt":27,"email":56},"Ji ZHU, MD",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Ji Zhu","Principal Investigator","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":86,"type":87},10,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93,94],"Chronic Radiation Induced Intestinal Injury","Chronic Radiation Enteritis","NOT_YET_RECRUITING","2025-09-09",{"date":98,"type":99},"2025-09-16","ACTUAL",{"date":101,"type":87},"2025-10-01",{"date":103,"type":87},"2026-12-31",{"name":5,"class":6},1]