NCT02172924Unknown1 期
A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Actuarial survival at one year after onset of graft versus host disease
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.
详细描述
Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
- •Are on calcineurin inhibitor and high dose corticosteroids.
排除标准
- •Terminally ill patients
结局指标
主要结局
Actuarial survival at one year after onset of graft versus host disease
时间窗: 12 months after inclusion
次要结局
- Response at 28 days after onset of graft versus host disease(28 days after inclusion)
- Incidence of severe infections(Up to 12 months after inclusion)
- Disease free survival(12 months after inclusion)
- Side effects(Up to 6 months after inclusion)
研究者
Olle Ringdén
Professor
Karolinska Institutet
研究点 (2)
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