Double-blind Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Allogenic Umbilical Cord Blood and Erythropoietin for Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Changes in Standardized Gross Motor Function
研究概览
简要总结
This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.
详细描述
Cerebral palsy is a disorder of movement and posture that result from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability through one's life. Umbilical cord blood(UCB) is suggested as therapeutic method for cerebral palsy which resulted from animal studies. Stem cells included in UCB is expected to exert therapeutic efficacy for functional recovery.
It is also suggested that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed to be neuroprotection and neurogenesis which would reinforce the effect of stem cell as well.
Although autologous umbilical cord would be safe, the children who have problems at birth seldom have autologous umbilical cord blood. Allogenic umbilical cord blood might be useful for these children if its effect is approved.
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
- 10 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known cerebral palsy
- •Willing to comply with all study procedure
排除标准
- •High risk of pneumonia or renal function deterioration after using of immunosuppressant
- •Presence of known genetic disease
- •Possibility of drug hypersensitivity which is related to this study remedy
- •History of previous cell therapy
- •Poor cooperation of guardian,including inactive attitude for rehabilitation
- •Intractable seizure disorder
研究组 & 干预措施
Umbilical Cord Blood & Erythropoietin & Rehabilitation
Allogenic umbilical cord blood infusion, erythropoietin injection & active rehabilitation
干预措施: Umbilical Cord Blood Infusion (Biological)
Umbilical Cord Blood & Erythropoietin & Rehabilitation
Allogenic umbilical cord blood infusion, erythropoietin injection & active rehabilitation
干预措施: Erythropoietin Injection (Drug)
Umbilical Cord Blood & Erythropoietin & Rehabilitation
Allogenic umbilical cord blood infusion, erythropoietin injection & active rehabilitation
干预措施: Active Rehabilitation (Other)
Erythropoietin & Rehabilitation
Erythropoietin injection, active rehabilitation
干预措施: Erythropoietin Injection (Drug)
Erythropoietin & Rehabilitation
Erythropoietin injection, active rehabilitation
干预措施: Active Rehabilitation (Other)
Erythropoietin & Rehabilitation
Erythropoietin injection, active rehabilitation
干预措施: Placebo Umbilical Cord Blood (Other)
Only Rehabilitation
Active rehabilitation
干预措施: Active Rehabilitation (Other)
Only Rehabilitation
Active rehabilitation
干预措施: Placebo Umbilical Cord Blood (Other)
Only Rehabilitation
Active rehabilitation
干预措施: Placebo Erythropoietin (Other)
结局指标
主要结局
Changes in Standardized Gross Motor Function
时间窗: Baseline - 1 month - 3 months - 6 months
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0\~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
Changes in Motor Performance
时间窗: Baseline -1 month - 3 months - 6 months
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
次要结局
- Changes in Brain MRI(Baseline - 6 months)
- Changes in Functional Performance in Daily Activities(Baseline -1 month - 3 months - 6 months)
- Changes in Muscle Strength(Baseline - 1 month - 3 months - 6 months)
- Changes in Hand Function(Baseline - 1 month - 3 months - 6 months)
- Changes in Cognitive Neurodevelopmental Outcome(Baseline -1 month - 3 months - 6 months)
- Changes in Functional Independence in Daily Activities(Baseline - 1 month - 3 months - 6 months)
- Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant(6 months)
- Changes in Motor Neurodevelopmental Outcome(Baseline - 1 month - 3 months - 6 months)
- Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism(Baseline - 2 weeks)