Chronic Radiation Enteritis, Chronic Radiation Induced Intestinal Injury
Conditions
Brief 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.
Interventions
BIOLOGICALUCB-MNCs
UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Vienna Rectoscopy Score (VRS) | At 3 and 12 months after the last treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate | At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment. | 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. |
| Change from baseline LENT-SOMA scoring scale | At 3 months and 12 months after the last treatment. | 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. |
| Change from baseline visual analog scale (VAS) | At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment. | 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. |
| Hemoglobin concentration | 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 | At 1 week and 1 month after the last treatment. | Intestinal flora distribution specifically describes the composition, quantity, and proportional balance of the microbial species. |
Countries
China
Contacts
Primary ContactJi ZHU
Outcome results
None listed