Decidual Stromal Cells (DSC) in Treatment of Steroid-Refractory Graft-vs-host Disease in a Recipient of Matched Related Donor Allogeneic Hematopoietic Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Aspartate Transaminase levels
研究概览
简要总结
This is a single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.
排除标准
- 未提供
研究组 & 干预措施
Patient with MDS/MPN
DSCs will be given 1 × 10^6 cells per kilogram of participant's body weight intravenously, administered once per week up to a maximum of six weeks depending on the clinical response.
干预措施: Decidual stromal cells (DSC) (Biological)
结局指标
主要结局
Aspartate Transaminase levels
时间窗: 6 weeks
Graft-Versus-Host Disease Severity
时间窗: 6 weeks
By grade
Alanine aminotransferase levels
时间窗: 6 weeks
Eastern Cooperative Oncology Group Performance Status Score
时间窗: 6 weeks
Bilirubin levels
时间窗: 6 weeks
C-reactive protein levels
时间窗: 6 weeks
Alkaline phosphatase levels
时间窗: 6 weeks
Karnofsky Performance Score
时间窗: 6 weeks
次要结局
未报告次要终点