A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Days to disappearence of macroscopic hematuria or clots
研究概览
简要总结
A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.
详细描述
Patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. Patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemorrhagic cystitis grade 2-4
- •Receives Misoprostol therapy
排除标准
- •Patients with urinary urge without macroscopic hematuria or clots
研究组 & 干预措施
Decidual Stromal cell therapy
Decidual stromal cell therapy (approximately 1x10^6 cells/kg) for hemorrhagic cystitis in addition to Misoprostol therapy (0,2mg, 3 times/day) on two occasions at weekly intervals.
干预措施: Decidual stromal cells (Biological)
Placebo
Receives placebo (masked i.v. infusion, same amount as an infusion of decidual stromal cells) in addition to Misoprostol therapy (0,2mg, 3 times/day).
干预措施: Placebo (Biological)
结局指标
主要结局
Days to disappearence of macroscopic hematuria or clots
时间窗: 1 month after inclusion
Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.
次要结局
- Time to disappearance of pain or urges(1 month after inclusion)
- Time to disappearance of microscopic hematuria(1 month after inclusion)
- Transplant related mortality(1 year after inclusion)
- Incidence of severe infections(1 year after inclusion)
- Incidence of graft versus host disease(One year after inclusion)
- Overall actuarial survival(Actuarial)
研究者
Olle Ringdén
Professor
Karolinska Institutet