Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis (NCT07175207) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis
China10 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline Vienna Rectoscopy Score (VRS)
Timeframe: At 3 and 12 months after the last treatment.
. 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;
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;