Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 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 Rheumatoid Arthritis.
详细描述
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.
To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Aged 18-80 Rheumatoid Arthritis patient;
- •Patients must consent in writing to participate in the study by signing and dating an informed consent document;
- •Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
- •Stage I and II according to X-ray.
排除标准
- •History of neurological disease, head injury or psychiatric disorder;
- •Pregnant women;
- •Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
- •Progressive apoplexy;
- •With malignant tumors;
- •Patients who had participated in other clinical trials within three months prior to this study.
研究组 & 干预措施
hUC-MSC + DMARDs
Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
干预措施: hUC-MSC + DMARDs (Biological)
DMARDs
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
干预措施: DMARDs (Drug)
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
- Disease Activity Score (DAS 28) Index(1, 3, 6 and 12 months)
- RA Serology(1, 3 ,6 and 12 months)