A Study on the Efficacy and Safety of Endoscopic Local Injection of Umbilical Cord Mesenchymal Stem Cells（TH-SC01） for the Treatment of Radiation-induced Rectal Injury.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- lentsoma score scale improved > 0.6 points
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury.
详细描述
radiation-induced rectal injury (RRI) is a common clinical disease. The symptoms of RRI often include: Abdominal pain, diarrhea, hematochezia, etc., especially chronic radiation-induced late rectal injury (RLRI), are easy to cause the disease to prolong and not heal. Some patients will have severe complications such as massive rectal bleeding, rectal stenosis, intestinal obstruction, deep ulcer, intestinal perforation, and fistula formation after the disease progresses to the advanced stage, most of which occur 2-5 years after the end of radiotherapy. The incidence of radiation rectal injury is high, which has a serious impact on the health and quality of life of patients. Currently, the commonly used treatment methods include non-steroidal anti-inflammatory drugs, mucosal protective agents, hemostatic agents, compound enema preparations, hyperbaric oxygen, surgical treatment, etc., but there is still no standard treatment strategy and effective plan, and clinical treatment is extremely difficult.
Mesenchymal stem cells have the properties of proliferation, differentiation, immune regulation and angiogenesis. There are few clinical studies on the use of mesenchymal stem cells in the treatment of radiation-induced rectal injury. Good therapeutic effect was achieved in vivo and in vitro in the preliminary experiment. The aim of this study was to verify the safety and efficacy of allogeneic mesenchymal stem cells from healthy donors in RRI patients.
Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of TH-SC01.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fully understand and sign the informed consent form;
- •Age ≥18 years and <80 years;
- •Patients diagnosed with chronic radiation rectal injury after radiation therapy;
- •Patients with LENT-SOMA scale score ≥1;
- •Good physical condition (WHO functional status score 0-1).
排除标准
- •The patient had severe liver and kidney disease;
- •Severe congestive heart failure or coronary heart disease;
- •Patients have allergic constitutions or severe systemic immune diseases;
- •The patient had active gastrointestinal hemorrhage or acute intestinal obstruction;
- •Patients were pregnant or had other conditions that the investigators deemed unsuitable for inclusion in the study.
结局指标
主要结局
lentsoma score scale improved > 0.6 points
时间窗: 16 weeks
lentsoma scale can comprehensively reflect the severity of radiation-induced rectal injury from three aspects: subjective feeling, objective situation and intervention measures. There are 14 items in total, each item has a maximum of 4 points, and the final total is divided by 14.
次要结局
- The decreased levels of SF-36 Scale(16 weeks)
- The decreased levels of Hospital Anxiety and Depression Scales(16 weeks)
- The declining level of the Vienna Rectoscopy Score(16 weeks)
- The decreased level ofSemi-quantitative Score of Rectal Radiological Pathological Injury(16 weeks)
- The decreased levels of Visual Analogue Pain Rating Scale(16 weeks)
- Serious adverse event occurred(2 years)
- The decreasing level of the Rectal Telangiectasia Density Scale(RTD)(16 weeks)