Regenerative Stem Cell Therapy for Stroke in Europe
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Between-group difference of NIHSS (stroke severity score)
研究概览
简要总结
Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.
详细描述
RESSTORE European multicentre randomised phase IIb will explore the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADSC) in 400 stroke patients. Therapeutic effects of ADSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and blood biomarkers.
The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, biobanking...).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hemispheric ischemic stroke (>1.5cm)
- •Inclusion from 1 to 4 days post-stroke
- •NIHSS > or = 7
- •No craniectomy
- •Able to follow a rehabilitation program
- •Modified Rankin scale = 0 before stroke onset
排除标准
- •Severe leucoariosis
- •Previous stroke
- •Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV
- •History of cancer
- •Pregnancy, breast feeding
结局指标
主要结局
Between-group difference of NIHSS (stroke severity score)
时间窗: 6 months after stroke onset
次要结局
未报告次要终点