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

University of Chinese Academy Sciences

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Chronic Radiation Induced Intestinal Injury; Chronic Radiation Enteritis

Treatments: Biological: UCB-MNCs

Study type: Interventional

Funder types: Other

Identifiers

NCT07175207

2025&UCB-MNCs&CRE

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

UCB-MNCs

Experimental group

Description:

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

Treatment:

Biological: UCB-MNCs