EUCTR2015-000168-32-NL进行中（未招募）1 期
Mesenchymal stem cells for Angiogenesis and Neovascularization in digital Ulcers of Systemic sclerosis - MANUS Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •- Age >18 years
- •- Established diagnosis of SSc according to criteria of the American College of Rheumatology (2013)
- •- At least one active digital ulcer (painful area, >2 mm in diameter with visible depth and loss of dermis) refractory to intravenous prostacyclins
- •------------‘Refractory to prostacyclins’ is defined as
- •?-Worsening of ulcer(s) at 1 month after prostacyclins iv
- •?-No improvement of ulcer(s) at 2 months after prostacyclins iv, as judged by the referring physician
- •?-Recurrence of exactly the same ulcer(s) (same location) at 3 months after prostacyclins iv
- •- 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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Ulcer with underlying calcinosis (ruled out by X-ray prior to referral)
- •-History of neoplasm or malignancy in the past 10 years
- •- Pregnancy or unwillingness to use adequate contraception during study
- •- Serious known concomitant disease with life expectancy <1 year
- •- Uncontrolled hypertension
- •- Uncontrolled acute or chronic infection
- •- Follow-up impossible.
研究者
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