NCT02790762Unknown1 期
A Phase I Study of Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
Shenzhen Hornetcorn Bio-technology Company, LTD1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Severity of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.
详细描述
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments.
To investigate the effects of hUC-MSC treatment for Pneumoconiosis, 10 patients with Pneumoconiosis will be enrolled and receive 4 times of hUC-MSC transplantation.
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
- •The patient who have signed the informed consent document;
- •Clinical and radiological evidence of liver cirrhosis.
排除标准
- •Pregnant women or lactating mothers;
- •History of neurological disease, head injury or psychiatric disorder;
- •Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
- •With malignant tumors;
- •Abnormal blood coagulation, combine other tumor or special condition;
- •Patients who had participated in other clinical trials within three months prior to this study.
结局指标
主要结局
Severity of adverse events
时间窗: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
次要结局
- Lung function as assessed by spirometry(1, 3 ,6 and 12 months)
- The level of type Ⅲ procollagen peptide in serum(1, 3 ,6 and 12 months)
- The level of ceruloplasmin in serum(1, 3 ,6 and 12 months)
- Chest high kilovolt X-ray examination(12 month)
- Immunological Indicator in serum(1, 3 ,6 and 12 months)
研究者
研究点 (1)
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