Mesenchymal Stem Cell for Treatment of Chronic Graft-versus-host Disease After Allogenetic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease.
详细描述
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Glucocorticoids (Drug)
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.
干预措施: cyclosporine (Drug)
Control group
Glucocorticoids and CsA will be used for treatment.
干预措施: Glucocorticoids (Drug)
Control group
Glucocorticoids and CsA will be used for treatment.
干预措施: cyclosporine (Drug)
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.
干预措施: Mesenchymal stem cells (Biological)
结局指标
主要结局
ORR
时间窗: 12 weeks after the first dose of MSCs
Overall response rate （ORR）includes complete response (CR) and part response (PR).
次要结局
- Response rate(4 weeks after the first dose of MSCs)
- EBV DNA-emia(1 year after the first dose of MSCs)
- OS(1 year after the first dose of MSCs)
- DFS(1 year after the first dose of MSCs)
- CMV DNA-emia(1 year after the first dose of MSCs)
- PGF(1 year after the first dose of MSCs)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University