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

NCT07175207 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2025&UCB-MNCs&CRE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Radiation Induced Intestinal Injury; Chronic Radiation Enteritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline Vienna Rectoscopy Score (VRS)

  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.

  At 3 and 12 months after the last treatment.

Secondary Outcomes (5)

• Clinical remission rate

  At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.

• Change from baseline LENT-SOMA scoring scale

  At 3 months and 12 months after the last treatment.

• Change from baseline visual analog scale (VAS)

  At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.

• 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.

Study Arms (1)

UCB-MNCs

EXPERIMENTAL

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

Biological: UCB-MNCs

Interventions

UCB-MNCs BIOLOGICAL

UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.

UCB-MNCs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Ji ZHU

CONTACT

0571-88128212; zhuji@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)