NCT02172963已完成1 期
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Response at day 28 after onset of hemorrhagic cystitis
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.
详细描述
Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10^6 cells/kg once or at weekly intervals dependent on clinical effect.
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
- •Hemorrhagic cystitis grade 2-4
排除标准
- •Urinary urge without macroscopic hematuria or clots
结局指标
主要结局
Response at day 28 after onset of hemorrhagic cystitis
时间窗: 28 days after inclusion
Disappearance of macroscopic hematuria.
次要结局
- Time to disappearance of pain or urges(Up to 6 months after inclusion)
- Actuarial survival at one year after onset of hemorrhagic cystitis(One year after inclusion)
- Time to disappearance of microscopic hematuria(Up to 84 days after inclusion)
- Transplant related mortality(Up to one year after inclusion)
- Incidence of severe infections(Up to one year after inclusion)
- Incidence of graft versus host disease(Up to one year after inclusion)
研究者
Olle Ringdén
Professor
Karolinska Institutet
研究点 (2)
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