Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Score of "Battelle Developmental Inventory"
研究概览
简要总结
The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic evolution of the pediatric patients with hypoxic/ischemic brain injury.
详细描述
There is accumulating evidence that shows that the placement of hematopoietic cells in the brain may increase growth-enhancing factors of axons and generate active neurons in the receptor. It has been found that after introducing hematopoietic cells in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be deliver more efficiently to the injured area, when compared to the intravenous route. Patients will be stimulated 4 times and then harvest the bone marrow. Bone marrow will be processed in order to obtain hematopoietic cells (CD34+) and minimize the erythrocytes amount. A inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will be evaluated with the "Battelle Developmental Inventory" before the procedure and one and six months after that. An MRI will be performed before the procedure and six months after that.
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypoxic/ischemic brain injury, with an between 1 month and 18 years, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours.
排除标准
- •Patients with neurodegenerative or autoimmune diseases.
- •Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure.
- •Patients who do not sign the informed consent form.
- •Elimination Criteria
- •Patients with severe meningeal abnormalities at the time of procedure.
- •Patients who did not attend subsequent assessments 30 and 180 days after the procedure.
- •Patients who die from causes related to neurological disease within 180 days after procedure.
- •Patients who are diagnosed with neurodegenerative or autoimmune diseases after the procedure.
- •Patients who do not bear the proper stimulation process with Granulocyte Colony Stimulating Factor (G-CSF), either by misapplication, lack thereof, or severe adverse drug reaction.
- •Patients choosing to leave the study.
结局指标
主要结局
Score of "Battelle Developmental Inventory"
时间窗: 30 days
次要结局
- Score of "Battelle Developmental Inventory"(180 days)