Effect of Intrathecal Transplant of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Gross Motor Function Measure-66
研究概览
简要总结
This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy.
详细描述
Cerebral palsy is one of the most common congenital (existing at or before birth) disorders of childhood.Spastic cerebral palsy causes stiffness and movement difficulties.There is no cure for the disease now.
This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy. hAEC will be intrathecal transplanted. Functional status is determined by Gross Motor Function Measure-66 and Fine Motor Function Measure. Spasticity is evaluated by using modified Ashworth scale(MAS).
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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent document;
- •Gross Motor Function Classification System (GMFCS) levels III-V;
- •Parents accepted voluntarily cell therapy for their children and followed-up.
排除标准
- •Have a history of severe allergic;
- •Serological tests such as AIDS, hepatitis B, syphilis, etc;
- •Hereditary metabolic diseases of nervous system;
- •Tumor or Hematological diseases.
结局指标
主要结局
Gross Motor Function Measure-66
时间窗: 6 months
Gross Motor Function Measure-66 is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline.
次要结局
- Gesell Developmental Scales(6 months)
- Fine Motor Function Measure(6 months)
- Modified Ashworth Scale(6 months)