Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease. (CMM/EICH/2008)
Multicenter Clinical Trial Phase I/II Randomized, Controlled, for the Evaluation of Safety and Feasibility of Therapy With Two Different Doses of Allogenic Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
The main purpose of this trial is to assess the safety and feasibility of treatment with two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed chronic and extensive graft versus host disease (GVHD).
Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not express class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation of allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting cell division and maintaining these cells in a quiescent state. This supports the hypothesis that MSCs are universal suppressors.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Granada.、西班牙、18014.
- Hospital Universitario Virgen de las Nieves
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Sevilla、西班牙、41013
- Hospital Universitario Virgen del Rocío de Sevilla
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Valencia、西班牙、46010
- Hospital Clínico de Valencia
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Cádiz.
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Jerez de la Frontera、Cádiz.、西班牙、11407
- Hospital de Jerez de la Frontera.
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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:
Patients who develop chronic extensive GVHD as determined by the National Institute of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD (Biol Blood Marrow Transplant 2005; 11: 945-955), and which meet the following criteria:
- They have never received therapy for chronic GVHD.
- They have de novo or quiescent chronic extended GVHD.
Exclusion Criteria:
- Concomitant severe systemic infection.
- Oncologic or hematological condition relapse.
- Pregnancy.
- Estimated life expectancy less than 1 week.
- Patients who do not give their informed consent.
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：Conventional treatment plus high dose: 3x10e6 cells / Kg.
Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks.
Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin.
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Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Low dose: 1 x10e6 / Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. High dose: 3 x10e6/Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
|
实验性的：Conventional treatment plus low dose: 1x10e6 cells / Kg
Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks.
Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin.
|
Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Low dose: 1 x10e6 / Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. High dose: 3 x10e6/Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of adverse events
大体时间：24 months
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24 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Percentage of patients in each group that may potentially reduce corticosteroids at week 7, 20 and 42, started immunosuppressive treatment and percentage of patients at week 56 have been suspended on full immunosuppressive treatment
大体时间：12 months
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12 months
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Overall survival and disease-free survival.
大体时间：12 months
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12 months
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Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.
大体时间：12 months
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12 months
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合作者和调查者
调查人员
- 学习椅：Manuel Jurado Chacón, MD、Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain.
- 首席研究员：Ildefonso Espigado, MD、Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain.
- 首席研究员：Carlos Solano Vercet, MD、Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain.
- 首席研究员：Sebastián Garzón López., MD、Hospital de Jerez de la Frontera, Cádiz. Spain.
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
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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