NCT04184258已完成1 期
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Efficacy evaluation
研究概览
简要总结
Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE diagnosis (4 of 11 criteria by ACR);
- •positive dsDNA;
- •SELENA-SLEDAI index ≥6;
- •active lupus nephritis;
- •patient can read, understand and follow the procedures.
排除标准
- •need for dialysis;
- •planned renal transplantation;
- •any medical condition which can be associated with the high risk for the patient;
- •pregnancy/lactation;
- •chronic infections, including hepatitis B/C, tuberculosis, HIV;
- •any malignant tumor in the last 5 years.
研究组 & 干预措施
SLE patients MSC treatment
Experimental
Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols
干预措施: Standard treatment according to the Clinical protocols (Other)
SLE patients standard treatment
Active Comparator
Patients with SLE, who receive standard treatment according to the Clinical protocols
干预措施: Standard treatment according to the Clinical protocols (Other)
SLE patients MSC treatment
Experimental
Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols
干预措施: Pooled mesenchymal stem cell (Biological)
结局指标
主要结局
Efficacy evaluation
时间窗: 6 month
Efficacy evaluation (SELENA-SLEDAI)
次要结局
- Safety eveluation(1 month)
研究者
研究点 (1)
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