NCT01522716终止1 期
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in disease activity according to National Institute of Health criteria
研究概览
简要总结
The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
- •Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects
排除标准
- •Active malignancy
- •Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
结局指标
主要结局
Change in disease activity according to National Institute of Health criteria
时间窗: Baseline to 9 months
Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score.
次要结局
- Change in self-assessed disease activity and quality of life(Baseline to 9 months)
- Change in disease activity as measured by histological examination(Baseline to 9 months)
- Freedom from steroids at 1 year after MSC treatment(1 year after finishing treatment)
- Safety (Adverse events, infections and relapse)(21 months)
研究者
Lena von Bahr
Leg läkare
Karolinska Institutet
研究点 (1)
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