JPRN-UMIN000031940已完成2 期
Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis - Autologous hematopoietic stem cell transplantation for severe systemic sclerosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
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
- 16years-old 至 65years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •A patient with one of the following severe organ complication, a) Heart: uncontrollable arrhythmia, uncontrollable heart failure, LVEF is less than 50% in cardiac ultrasound examination, moderate or more pulmonary hypertension (mean pulmonary artery pressure is 40 mmHg or more) b) Lung: PaO2 is less than 60 mmHg at room air, %VC is less than 50%. %DLCO is less than 20%. c) Kidney: renal glomerular filtration rate is less than 40 ml/min, serum creatinine is 2 mg/dl or more. d) Uncontrolled malignant neoplasm e) Uncontrollable infection. f) Cyclophosphamide is used more than 10 g in total.
研究者
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