NCT06925607尚未招募1 期
A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.0 个研究点目标入组 6 人开始时间: 2025年4月最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
- 主要终点
- Radioactive distribution
研究概览
简要总结
A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Good physical condition (WHO performance status score 0-1).
- •Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
- •Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.
- •The LENT-SOMA score was ≥1 during the screening period.
- •All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
排除标准
- •Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.
- •Patients with allergic constitution or severe systemic autoimmune diseases.
- •Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.
- •Pregnant or lactating women.
- •Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
- •Patients with a LENT-SOMA score of 4 during the screening period.
- •Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.
- •Patients with uncontrolled tumors, tumor recurrence or metastasis.
- •Subjects received any investigational drug within 3 months prior to the screening.
- •Subjects received stem cell treatment.
- •Participants considered inappropriate to participate in this clinical trial
研究组 & 干预措施
MSCs treatment group
Experimental
干预措施: Mesenchymal Stem Cells (MSCs) (Drug)
结局指标
主要结局
Radioactive distribution
时间窗: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour
The radioactive distribution in the injection site and various organs or tissues after local injection in patients with radiation proctitis
次要结局
- Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events(Week1, Week 4, Week 24，Month 24)
- Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement.(Week 4，Week 24)
- Radiation exposure(Week 1)
研究者
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