The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes in Short-term Memory Function
研究概览
简要总结
This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients.
The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.
详细描述
Traumatic brain injury patients have been increasing due to various accidents. After acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. However, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. Cell therapy like Umbilical cord blood (UCB) transplantation has showed promising results in many animal studies. The mechanism of such neurological improvement is not fully understood. Stem cells included in UCB are expected to secrete neurotrophic factors to enhance brain function. In addition, anti-inflammatory effects of UCB are suggested. Autologous UCB are not available in most of the cases in fact. The aim of this clinical trial is to determine the safety and efficacy of allogeneic UCB.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)
- •Glasgow Outcome Scale: 2, 3, 4, 5
排除标准
- •High risk of pneumonia or renal function deterioration after immunosuppressant
- •Possibility of drug hypersensitivity which is related to this study remedy
- •Intractable seizure disorder
- •Poor cooperation of guardian,including inactive attitude for rehabilitation
结局指标
主要结局
Changes in Short-term Memory Function
时间窗: Baseline - 6 months
次要结局
- Changes in Emotion and Personality(Baseline - 6 months)
- Changes in Behavior(Baseline - 6 months)
- Changes in Global Outcome(Baseline - 6 months)
- Changes in Intelligence(Baseline - 6 months)
- Changes in Frontal Lobe Function(Baseline - 6 months)
- Changes in Attention(Baseline - 6 months)
- Changes in Traumatic Brain Injury-related Symptoms(Baseline - 6 months)
- Changes in Motor Function and Activities of Daily Living(Baseline - 6 months)
- Changes in Brain Structure(Baseline - 6 months)
- Changes in Brain Glucose Metabolism(Baseline - 2 weeks)
研究者
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital