Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Cognitive Function
研究概览
简要总结
The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy.
Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as Cerebral palsy with total body involvement type
- •Age between 6 month - 3 years old
- •Parents requesting for cell therapy
- •The parents give sign in informed consent form do to examination, therapy, blood sampling collection and observation for their child
排除标准
- •Head circumference less than -3 SD (more than 3 cm) Nellhaus standard
- •Have diagnosed meningitis and encephalitis
- •Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital, cytomegalovirus
- •Have diagnosed metabolic disorder, chromosome disorder, congenital malformation or neuroregeneratif disease
- •Progressive disorder
- •Regressive development disorder
- •Severe anatomical abnormalities in Brain MRI
研究组 & 干预措施
UCMSCs + CM
UCMSCs + CM is administered via intrathecal injection
干预措施: Umbilical Cord Mesenchymal Stem Cells (Biological)
UCMSCs + CM
UCMSCs + CM is administered via intrathecal injection
干预措施: Conditioned Medium (Biological)
UCMSCs
UCMSCs is administered via intrathecal injection
干预措施: Umbilical Cord Mesenchymal Stem Cells (Biological)
Standard Therapy
Physiotherapy
干预措施: Standard Therapy (Other)
结局指标
主要结局
Cognitive Function
时间窗: 6 month after stem cells
Bayley Scales of Infant Development (BSID) version III
Gross Motor Function
时间窗: 6 month after stem cells
Gross Motor Function Classification System (GMFCS)
Gross Motor Function
时间窗: 3 month after stem cells
Gross Motor Function Classification System (GMFCS)
Cognitive Function
时间窗: 3 month after stem cells
Bayley Scales of Infant Development (BSID) version III
次要结局
- Chemical Marker(6 month after stem cells)
- Chemical Marker(3 month after stem cells)