Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Actuarial survival at six months after first DSC infusion
研究概览
简要总结
The purpose of this study is to evaluate 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 1-2x10^6 cells/kg at one or more occasions 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-
- •Are on calcineurin inhibitor and high dose corticosteroids.
排除标准
- 未提供
研究组 & 干预措施
Decidual Stromal Cells as last line treatment
Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids without any signs of improvement will be given DSCs to evaluate a possible effect. DSCs will be thawed from the freezer in plasma.
干预措施: Decidual Stromal Cells thawed in plasma (Biological)
Decidual Stromal Cells
Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids will be given DSCs as early as possible at one or more occasions at weekly intervals dependent on clinical response. DSCs will be thawed from the freezer in plasma.
干预措施: Decidual Stromal Cells thawed in human albumin (Biological)
结局指标
主要结局
Actuarial survival at six months after first DSC infusion
时间窗: 6 months after inclusion
次要结局
- Incidence of severe infections(Up to one year after inclusion)
- Response at 168 days after onset of graft versus host disease(Up to 168 days after inclusion)
- Side effects(Up to 6 months after inclusion)
- Disease free survival(Up to one year after inclusion)
- Response at 28 days after onset of graft versus host disease(28 days after inclusion)
- Response at 84 days after onset of graft versus host disease(Up to 84 days after inclusion)
研究者
Olle Ringdén
Professor
Karolinska Institutet