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

Not Applicable

Not yet recruiting

• Conditions: Chronic Radiation Induced Intestinal Injury; Chronic Radiation Enteritis
• Interventions: Biological: UCB-MNCs

• Registration Number: NCT07175207
• Lead Sponsor: Zhejiang Cancer Hospital

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 therapeutic effect and adverse reactions of UCB-MNCs in treating CRE.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Aged 18-75 years, with no restriction on gender;
2. History of pelvic and abdominal radiotherapy;
3. Patients diagnosed with chronic radiation-induced intestinal injury (CRII) via colonoscopy and pathological examination (≥3 months after the end of radiotherapy);
4. 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;
5. Poor response to conventional treatment for two weeks, with symptoms showing no remission or progressive aggravation;
6. Well-controlled tumor for ≥3 months;
7. 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);
8. Expected lifespan of the subject ≥ 3 months;
9. The patient is informed of the study details and voluntarily signs the informed consent form;
10. 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

1. 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);
2. Positive results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
3. Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2;
4. Currently participating in another clinical trial or having participated in another clinical trial within 4 weeks;
5. Patients with an allergic diathesis or known allergy to the preparation used in this trial;
6. Patients with comorbid mental illness who are unable to cooperate with treatment;
7. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UCB-MNCs	UCB-MNCs	UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation

Primary Outcome Measures

Name	Time	Method
Change from baseline Vienna Rectoscopy Score (VRS)	At 3 and 12 months after the last treatment.	The VRS evaluates four core endoscopic features (mucosal hyperemia/erythema, mucosal ulceration, mucosal fibrosis/stenosis, 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.

Secondary Outcome Measures

Name	Time	Method
Clinical remission rate	At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.	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.
Change from baseline LENT-SOMA scoring scale	At 3 months and 12 months after the last treatment.	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.
Change from baseline visual analog scale (VAS)	At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.	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.
Hemoglobin concentration	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.
Changes in Intestinal Flora Distribution	At 1 week and 1 month after the last treatment.	Intestinal flora distribution specifically describes the composition, quantity, and proportional balance of the microbial species.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China