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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB-MNCs | Experimental | UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB-MNCs | Biological | UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3 and 12 months after the last treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji ZHU | Contact | 0571-88128212 | zhuji@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
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| 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. | 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. | At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment. |
| 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 | Intestinal flora distribution specifically describes the composition, quantity, and proportional balance of the microbial species. | At 1 week and 1 month after the last treatment. |