EUCTR2011-002434-40-DE进行中（未招募）1 期
Highdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosisModification according to manifestation - AST-MOMA
niversity Hospital Tuebingen0 个研究点目标入组 44 人开始时间: 2011年8月18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
- 44
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
- •?Limited or diffuse cutaneous systemic sclerosis with organ manifestation (lung/heart or kidney)
- •?Progressive disease despite cyclophosphamide treatment
- •?Cyclophosphamide i.v.: at least 3 x 500-1000 mg/m² every 3-4 weeks or
- •?Oral Cyclophosphamide with at least 100mg/day for at least 2 months or
- •?or contraindications for a cyclophosphamide treatment
- •?Written informed consent
- •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 44
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Age < 18 years
- •?Pregnancy or unwillingsness to use contraception
- •?Concomittend severe disease
- •?Heart insuffiency with EF < 30% (echo)
- •?Pulmonary arterial hypertension with papSys > 50mmHg
- •?Kidney insiffiency with Clearance for creatinine < 30ml/min
- •?Severe limitation in lung function test
- •?IVC < 50%
- •?DLCO = 30%
- •?Bone marrow defect
- •?Leukopenia < 2.000/ul
- •?Thrombopenia < 100.000/ul
- •?Cyclophosphamide sum dose > 50g (relative)
- •?Chronic infection (Hepatitis B/C, HIV, salmonella, lues, tuberculosis (relative)
- •?Severe psychiatric disease
- •?Abuse of nicotine, alcohol or any illegal drugs
- •?Poor compliance
研究者
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