A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.
详细描述
Patients with toxicity, inflammation or hemorrhages 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
- •Patients with toxicity, inflammation or hemorrhages.
排除标准
- 未提供
研究组 & 干预措施
Decidual stromal cell therapy for toxicity and inflammation
Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
干预措施: Decidual stromal cell therapy (Biological)
结局指标
主要结局
Number of adverse events
时间窗: Up to one year after inclusion
次要结局
- Time to disappearance of pain.(Up to one year after inclusion)
- Anti-inflammatory and reparatory effects regarding different lesions.(Up to one year after inclusion)
- Time to disappearance of hemorrhages.(Up to three months after inclusion)
- Time to disappearance of paresis and/or paresthesias.(Up to one year after inclusion)
- Time to disappearance of pulmonary infiltrates(Up to one month after inclusion)
- Time to disappearance of oxygen supplementation(Up to one month after inclusion)
- Incidence of severe infections(Up to one year after inclusion)
- Incidence of graft versus host disease(Up to one year after inclusion)
- Actuarial survival(Up to 5 years after inclusion)
研究者
Olle Ringdén
Professor
Karolinska Institutet