EUCTR2007-003341-32-NL进行中（未招募）不适用
Treatment of steroid resistant grade II to IV acute GVHD by infusion of mesenchymal stem cells expanded with human plasma and platelet lysate ; a phase I/II study - MSC for resistant GVHD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- 性别
- All
入选标准
- •1. For screening and MSC culture: newly diagnosed acute grade II-IV GVHD or chronic GVHD with an acute pattern matching grade II-IV after allogeneic stem cell transplantation
- •2. For infusion: steroid refractory grade II-IV acute GVHD or chronic GVHD with an acute pattern matching grade II-IV after allogeneic stem cell transplantation.
- •3. Patients must have received 2 mg/kg/day of prednisolon for at least 3 consecutive days and experience progression of GVHD or no response to at least 7 days of steroid treatment.
- •4. In addition to steroids the patient has received either cyclosporin (trough level 150-250 ng/ml) or tacrolimus (trough level 5-15 ng/ml). Patients with steroid refractory GvHD may be treated with second line therapy according to the clinical practice at the center while waiting for MSC infusion. At each center all patients included in the study should be treated in the same way.
- •5. Written informed consent.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with poor performance, not expected to survive 3 weeks.
- •2. Donor Chimerism below 90%
- •3. Active uncontrolled CMV, EBV or fungal infection
研究者
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