NCT04247945招募中2 期
Co-transplantation of Mesenchymal Stromal Cells in Allogeneic Hematopoietic Stem Cell Transplantation
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Survival Rate
研究概览
简要总结
Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Aged <65 years
- •Willing to transplant
- •Cardiac: Left ventricular ejection fraction ≥ 50%
- •Adequate renal and hepatic function
- •Performance status: Karnofsky ≥ 70%
排除标准
- •Pregnant or lactating females.
- •Any co-morbidity precluding the administration of MSCs.
结局指标
主要结局
Survival Rate
时间窗: up to 2 years after HSCT
次要结局
- Rates of Relapse(up to 2 years after HSCT)
- Incidence of Systemic Infections(up to 2 years after HSCT)
- Mean Time to Engraftment(Baseline to engraftment, assessed minimally 28 days post transplant)
- Transplant-Related Mortality(up to 1 months after HSCT)
- Cumulative Incidence of Graft-versus Host Disease(up to 2 years after HSCT)
研究者
Ting YANG
Professor of Hematology
Fujian Medical University
研究点 (1)
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