Status:
NOT_YET_RECRUITING
Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Chronic Radiation Induced Intestinal Injury
Chronic Radiation Enteritis
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 therapeut...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07175207
Start Date
October 1 2025
End Date
December 31 2026
Last Update
September 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China