NCT00916266已完成1 期
Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Instituto do Cerebro de Brasilia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年7月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- seizure frequency
研究概览
简要总结
This research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.
详细描述
The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for patients with temporal lobe refractory epilepsy. We are mainly evaluating seizure frequency, hippocampal volume an cognitive performance
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •temporal lobe medically refractory epilepsy patients with hippocampal atrophy
排除标准
- •under 18 or over 65 years old patients
- •previous neurological surgery
- •other neurodegenerative diseases
结局指标
主要结局
seizure frequency
时间窗: 6 months
次要结局
- adverse effects(6 months)
- hippocampal volume(6 months)
- cognitive performance(6 months)
研究者
Jaderson Costa da Costa
MD, PhD
Hospital Sao Lucas da PUCRS
研究点 (1)
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