EUCTR2013-003626-88-CZ进行中（未招募）1 期
The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation. - MSC for the treatment of GVHD after allogeneic stem cell transplantation
Fakultní nemocnice Plzen0 个研究点目标入组 25 人开始时间: 2014年1月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion criteria for patients:
- •- Age 18-70 years
- •- A signed informed consent
- •- Status after allogeneic HSCT complicated with GVHD (any type) with effective levels of CsA (min 150 ng/ml) and:
- •a) no response to corticosteroids at a minimum dose of 1mg/kg administered for at least 2 weeks
- •b) GVHD progressing during the abovementioned treatment
- •c) corticosteroid-dependent GVHD , ie, GVHD responding to corticosteroids, but with the necessity of continuous administration of a minimum dose of 0.1 mg Medrol/kg/day (or equivalent)
- •d) GVHD permanently requiring combination of ciclosporin and another immunosuppressant (eg. MMF etc.), while steroids are from any reason contraindicated or not tolerated
- •Inclusion criteria for donors:
- •- A signed informed consent
- •- Negativity for infectious disease markers according to the standard requirements (SÚKL, JACIE, WMDA)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Exclusion criteria for patients:
- •- poor performance status with expected survival < week
- •- treatment with extracorporeal phohotopheresis (ECP) in less than 3 months
- •- active uncontrolled infection of any type
- •- the assumption of non-compliance
- •- activity (progression) of the primary disease
- •The exclusion criteria for donors:
- •- age> 65 years
- •- positive testing for infectious diseases markers
研究者
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