JPRN-UMIN000028381招募中2 期
A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A clinical trial of autologous stem cell transplantation for severe systemic sclerosis
Department of Clinical Immunology and Rheumatology/Infectious Disease, Kyushu University Graduate school of Medicine0 个研究点目标入组 12 人开始时间: 2017年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 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
- 16years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) severe organ dysfunction as following a) severe arrhythmia leading to permanent implantation of a pacemaker or implantable cardioverter defibrillator, refractory chronic heart failure, reduced left ventricular ejection fraction lower than 50% at echocardiogram or severe pulmonary hypertension (mPAP >=30 mmHg) b) severe lung dysfunction (PaO2 <60 mmHg under room air conditions, %FVC <50% or %DLOC <20%) c) severe renal dysfunction (eGFR <40 ml/min or serum Cr >=2 mg/dl) d) d) liver abnormality (baseline AST, ALT or total bilirubin levels are >3 times higher than upper limit of normal) (2) presence of malignancy except for complete remission (3) presence of active infection (4) positive for HBs-Ag, HCV-Ab, HIV-Ab or HTLV1-Ab test (5) cumulative dose of more than 10 g of cyclophosphamide (6) history of anaphylaxis or hypersensitivity to murine IgG or iron-dextran complex (7) pregnancy or lactation (8) judged by the investigator to be inappropriate for study participation
研究者
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