Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- allergic reaction
研究概览
简要总结
Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy.
In this study the investigators evaluate the side effect of bone marrow stem cell transplantation in patients with cerebral palsy.
详细描述
Our study evaluate the side effects of bone marrow derived CD133 cells transplantation in 4-12years old patients with cerebral palsy.first all the patients undergone a comprehensive evaluation(physical exam, serology tests,EEG,MRI,GMFM66).
After bone marrow aspiration,autologous stem cells prepare for each patient. In operation room ,the cells are transplanted by intrathecal injection. all the patients would be under observed to notice acute side effects and 3,6,9 and 12 months after injection they will be followed and evaluate by comprehensive tests.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of spastic quadriplegic CP
- •Children must be between the ages of 4 and 12 years
- •Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees)
- •Children must be seizure-free or seizure controlled
排除标准
- •Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
- •Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
- •Children who have a metallic or electrical implants
研究组 & 干预措施
stem cell recipients
The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation
干预措施: CD133 stem cell injection (Biological)
结局指标
主要结局
allergic reaction
时间窗: 1 month
evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients
local infection
时间窗: 1 month
infections in site of injection
encephalitis
时间窗: 1 month
encephalitis due to cell transplantation
meningitis
时间窗: 1 month
meningitis due to cell trnsplantation
paralysis or sensory loss
时间窗: 6 months
paralysis or sensory loss below the level of the injection site
次要结局
- speech(6 months)
- motion(6 months)