Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
概览
- 阶段
- 1 期
- 干预措施
- Umbilical Cord Mesenchymal Stem Cells
- 疾病 / 适应症
- Cerebral Palsy
- 发起方
- PT. Prodia Stem Cell Indonesia
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Cognitive Function
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
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.
研究者
入排标准
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
UCMSCs + CM
UCMSCs + CM is administered via intrathecal injection
干预措施: Conditioned Medium
UCMSCs
UCMSCs is administered via intrathecal injection
干预措施: Umbilical Cord Mesenchymal Stem Cells
Standard Therapy
Physiotherapy
干预措施: Standard Therapy
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)