NCT07175207尚未招募1 期
Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Chronic Radiation Enteritis
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline Vienna Rectoscopy Score (VRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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;
- •The patient is informed of the study details and voluntarily signs the informed consent form;
- •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.
排除标准
- •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;
- •Pregnant or lactating women.
研究组 & 干预措施
UCB-MNCs
Experimental
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
干预措施: UCB-MNCs (Biological)
结局指标
主要结局
Change from baseline Vienna Rectoscopy Score (VRS)
时间窗: 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.
次要结局
- Clinical remission rate(At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.)
- Change from baseline LENT-SOMA scoring scale(At 3 months and 12 months after the last treatment.)
- Change from baseline visual analog scale (VAS)(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(At 1 week and 1 month after the last treatment.)
研究者
Ji Zhu
Principal Investigator
Zhejiang Cancer Hospital
研究点 (1)
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