Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Changes in Balance
研究概览
简要总结
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke.
详细描述
Stroke is one of the most common etiologies causing disability in developed countries. There remains no proven treatments except tissue plasminogen activator currently. Based on promising results of cell therapy in animal stroke models, efforts to apply cell therapy for patients with stroke has been made. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke
- •Onset duration over 12 months
- •Hemisphere lesions except brain stem and cerebellar lesions
- •National Institute Health Stroke Scale: 10 to 15
排除标准
- •Possibility of hypersensitivity drugs used in this study
- •Uncontrolled hypertension or cardiovascualr diseases
- •Malignant cancer
- •Renal or hepatic dysfunction (Consultation to specialist in nephrology or gastroenterology in case of renal or hepatic dysfunction)
- •Severe pulmonary dysfunction
- •Traumatic brain injury
- •Lack of matched UCB
结局指标
主要结局
Changes in Balance
时间窗: Baseline - 1 month - 3 months - 6 months - 12 months
次要结局
- Changes in Cognition(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Brain structure(Baseline - 12 months)
- Changes in Muscle strength and Spasticity(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Language(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Brain glucose metabolism(Baseline - 12 months)
- Changes in Neural activity(Baseline - 6 months - 12 months)
- Changes in Mobility(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Function of Upper extremity(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Activities of Daily Living(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Sensory function(Baseline - 1 month - 3 months - 6 months - 12 months)
- Monitoring Adverse Events(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Visual perception(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Hand function(Baseline - 1 month - 3 months - 6 months - 12 months)
研究者
MinYoung Kim, M.D.
Professor
Bundang CHA Hospital