JPRN-UMIN000029945尚未招募1 期
Phase I/II trial of AM01 (amnion-derived mesenchymal stem cells) for steroid-refractory acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation - Phase I/II trial of AM01 (amnion-derived mesenchymal stem cells) for steroid-refractory acute GVHD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Has received more than one treatment for acute GVHD other than steroid 2. Presence of liver dysfunction other than GVHD (serum total bilirubin >2.0mg/dl or serum AST/ALT >3 times upper limit of normal) 3. Presence of kidney dysfunction (serum creatinine >2.0mg/dl) 4. Percutaneous oxygen saturation is less than 94% even under oxygen administration 5. Presence of an uncontrolled severe infection 6. Presence of severe hypersensitivity to bovine-derived constituents, human serum albumin and gentamicin 7. History of hypersensitivity to iodine or iodine-containing contrast agent 8. Previous participation in a study of any treatment with cell therapy product 9. Previous participation in a study of any investigational treatment within 12 weeks of agreement for this study 10. In pregnancy or breast-feeding 11. Considered as ineligible to this study
研究者
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