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 Belarus2 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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 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.
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 (2)
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