Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
UCB-MNCs
Biological/VaccineUCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: UCB-MNCsExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
At 3 and 12 months after the last treatment.Secondary outcomes
1
Clinical remission rate
Symptoms such as hematochezia and diarrhea will be counted before treatment and at 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment. The corresponding symptom remission rate will be calculated by comparing with the pre-treatment status.
Time frame
At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.2
Change from baseline LENT-SOMA scoring scale
LENT-SOMA uses a 0-4 grading system for each of the four dimensions (subjective, objective, management, analytic), with scores directly reflecting the severity of radiation-induced tissue injury. A higher LENT-SOMA grade indicates more severe radiation-induced tissue damage.
Time frame
At 3 months and 12 months after the last treatment.3
Change from baseline visual analog scale (VAS)
VAS is a simple tool to measure pain extent: it uses a 10-centimeter horizontal line, with "no pain at all" marked at 0 and "worst pain imaginable" at 10. Patients mark a point matching their current pain.
Time frame
At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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