NL-OMON47582招募中2 期
Mesenchymal stem cells for angiogenesis and neovascularisation in digital ulcers of systemic sclerosis - MANUS Trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- 18 至 64（—）
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 5 days intravenous
- •prostacyclines
- •*Refractory to prostacyclins* is defined as
- •* - Worsening of ulcer(s) within 1 month after prostacyclins iv
- •* - No improvement of ulcer(s) after 2 months after prostacyclins iv, as judged
- •by the referring physician
- •* - Recurrence of exactly the same ulcer(s) (same location) within 3 months
- •after prostacyclins iv, - Written informed consent
排除标准
- •- Ulcer with underlying calcinosis (ruled out by X-ray prior to
- •screening/inclusion)
- •- 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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