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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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.
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.
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.
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.
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.
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Changes in Intestinal Flora Distribution
Intestinal flora distribution specifically describes the composition, quantity, and proportional balance of the microbial species.
Time frame: At 1 week and 1 month after the last treatment.