Not yet recruiting NCT07175207
Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UCB-MNCs.
- Who it may be relevant to
- Registry conditions: Chronic Radiation Induced Intestinal Injury, Chronic Radiation Enteritis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Chronic Radiation Enteritis
Overview
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.
Interventions
- Biological UCB-MNCs
UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.
Primary outcome measures
- Change from baseline Vienna Rectoscopy Score (VRS) [Time frame: At 3 and 12 months after the last treatment.]
Secondary outcome measures (5)
- Clinical remission rate [Time frame: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.]
- Change from baseline LENT-SOMA scoring scale [Time frame: At 3 months and 12 months after the last treatment.]
- Change from baseline visual analog scale (VAS) [Time frame: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.]
- Hemoglobin concentration [Time frame: 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 [Time frame: At 1 week and 1 month after the last treatment.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07175207 · 2025&UCB-MNCs&CRE