Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis

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;
• The patient is informed of the study details and voluntarily signs the informed consent form;
• 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.

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;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2;
• Currently participating in another clinical trial or having participated in another clinical trial within 4 weeks;
• Patients with an allergic diathesis or known allergy to the preparation used in this trial;
• Patients with comorbid mental illness who are unable to cooperate with treatment;
• Pregnant or lactating women.