NCT02291770Unknown3 期
Treatment of of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells. A Phase III Randomized Open Label Multi-center Study in Southern China.
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Proportion of patients responding to treatment of cGvHD with MSC
研究概览
简要总结
Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
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
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed cGvHD
- •Informed consent obtained from patient and donor.
- •Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
- •Have not received additional agent for cGVHD within 3 months.
- •Expected life is more than 90 days.
- •Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
- •Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
排除标准
- •Invasive fungal disease.
- •Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
- •Patient is with a history of hypersensitivity to bovine products.
- •Relapsed malignancy.
结局指标
主要结局
Proportion of patients responding to treatment of cGvHD with MSC
时间窗: 90 days
次要结局
- Overall survival(2 year)
- Adverse events(2 year)
- Progression-free survival(2 year)
- Cumulative incidents of non-relapse mortality(2 year)
- Time without systemic immunosuppression(2 year)
研究者
研究点 (1)
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