MSC for Treatment of cGVHD After Allo-HSCT
Mesenchymal Stem Cell for Treatment of Chronic Graft-versus-host Disease After Allogenetic Hematopoietic Stem Cell Transplantation
研究概览
详细说明
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cGVHD) remains an important complication that occurs in about 50% patients. The mortality of cGVHD and its complication could reach up to 50%,and cGVHD seriously influence the quality of life. At present, the first line treatment of cGVHD remains in discussion.
Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of cGVHD remains undetermined.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510515
- 招聘中
- Department of Hematology,Nanfang Hospital, Southern Medical University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- A patient age of 18-65 years
- Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Primary disease relapse
- Expected lifetime less than 3 months
- Patients with any conditions not suitable for the trial (investigators' decision)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：MSCs group
MSCs group refers to treatment with mesenchymal stem cells (1×10^6 cells/kg, intravenously) weekly for 8 doses.
Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently.
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Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 mins) weekly.
MSCs will be administrated for 8 doses.
Glucocorticoids (i.e.
Methylprednisolone) will be used with an initial dose of 1mg/kg.
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA.
The targeted concentration is 200-300 ng/Ml.
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有源比较器：Control group
Glucocorticoids and CsA will be used for treatment.
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Glucocorticoids (i.e.
Methylprednisolone) will be used with an initial dose of 1mg/kg.
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA.
The targeted concentration is 200-300 ng/Ml.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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ORR
大体时间：12 weeks after the first dose of MSCs
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Overall response rate （ORR）includes complete response (CR) and part response (PR).
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12 weeks after the first dose of MSCs
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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OS
大体时间：1 year after the first dose of MSCs
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Overall survival (OS)
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1 year after the first dose of MSCs
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DFS
大体时间：1 year after the first dose of MSCs
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Disease-free survival (DFS)
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1 year after the first dose of MSCs
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Response rate
大体时间：4 weeks after the first dose of MSCs
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4 weeks after the first dose of MSCs
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EBV DNA-emia
大体时间：1 year after the first dose of MSCs
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EBV DNA-emia refers to detection of EBV DNA in peripheral blood via PCR.
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1 year after the first dose of MSCs
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CMV DNA-emia
大体时间：1 year after the first dose of MSCs
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CMV DNA-emia refers to detection of CMV DNA in peripheral blood via PCR.
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1 year after the first dose of MSCs
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PGF
大体时间：1 year after the first dose of MSCs
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Poor graft function (PGF) refers to a slow or incomplete recovery of blood cell counts (ANC ≤0.5x10^9/L and PLT ≤20x10^9/L) by +28 days after allo-HSCT or a fall in blood cell counts to levels fulfilling the diagnostic criteria for PGF after successful and prompt hematopoietic engraftment.
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1 year after the first dose of MSCs
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合作者和调查者
合作者
调查人员
- 首席研究员：Qi-fa Liu, MD、Nanfang Hospital of Southern Medical University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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