Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Safety of MSC treatment.
研究概览
简要总结
Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid arthritis.
详细描述
This study was supported by the National Natural Science Foundation of China (30872618)，The Shanxi Province Social Development Public Relations Project (2012K13-02-35), and The Military Medicine and Public Health Plan (CLZ120GA23)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old.
- •Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
- •Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.
排除标准
- •Any history of ongoing, significant or recurring infections.
- •Any active inflammatory diseases other than RA.
- •Significant cardiac or pulmonary disease.
- •End-stage renal failure.
- •Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
研究组 & 干预措施
UC-MSCs Treatment
Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
干预措施: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) (Biological)
DMARDS
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
干预措施: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) (Drug)
UC-MSC+DMARDS
Patients will be treated in combination with UC-MSC and DMARDS.
干预措施: UC-MSC+DMARDS (Biological)
结局指标
主要结局
Safety of MSC treatment.
时间窗: six months
Adverse Events will be recorded in a patient or clinical investigation subject who administers MSC and will be evaluated a causal relationship with the treatment.
次要结局
- Patient's assessment of pain.(1, 3 and 6 months)
- RA Serology(1, 3 and 6 months)
- Disease Activity Score (DAS 28) Index Mean Change From Baseline(1, 3 and 6 months)