Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis (NCT07175207) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis
China10 participantsStarted 2025-10-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 18-75 years, with no restriction on gender;
✓. History of pelvic and abdominal radiotherapy;
✓. Patients diagnosed with chronic radiation-induced intestinal injury (CRII) via colonoscopy and pathological examination (≥3 months after the end of radiotherapy);
✓. 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;
✓. Poor response to conventional treatment for two weeks, with symptoms showing no remission or progressive aggravation;
✓. Well-controlled tumor for ≥3 months;
✓. 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);
✓. Expected lifespan of the subject ≥ 3 months;
Exclusion criteria
✕. 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);
✕. Positive results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
What they're measuring
1
Change from baseline Vienna Rectoscopy Score (VRS)
Timeframe: At 3 and 12 months after the last treatment.