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

NCT ID: NCT07175207

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UCB-MNCs

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

Group Type: EXPERIMENTAL

UCB-MNCs

Intervention Type: BIOLOGICAL

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

Interventions

UCB-MNCs

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji Zhu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Ji ZHU

Role: CONTACT

zhuji@zjcc.org.cn

0571-88128212

Facility Contacts

Ji ZHU, MD

Role: primary

zhuji@zjcc.org.cn

0571-88128212

Other Identifiers

2025&UCB-MNCs&CRE

Identifier Type: -

Identifier Source: org_study_id