NCT01624779已完成1 期
The Effect of Intrathecal Transplantation of Autologous Adipose Tissue Derived Mesenchymal Stem Cells in the Patients With Spinal Cord Injury, Phase I Clinical Study
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Significant MRI Change before and after intervention
研究概览
简要总结
The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.
研究设计
- 研究类型
- Interventional
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who don't have any possiblity of improving neurological function despite performed the optimal treatment after spinal cord injury
- •No change in neurological function for 4weeks interval by at least 2 clincal medical specialists
- •Patient who is able to give written informed consent of clinical trial about stemcells treatment
排除标准
- •Patient who is under 19 years and over 70years
- •Patient who must use the mechanical ventilator
- •Patient who have a history of malignant tumor within 5 years
- •Patient who is having a infectious disease of including current hepatitis and HIV
- •Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history)
- •Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day
- •Patient who is having an anemia or thrombopenia
- •Patient who is having an angina, myocardial infarct, myocardiopathy, obstructive vessel disease, chronic renal failure, glomerulopathy and chronic obstruent lung disease (confirm subject's history from their medical history)
- •Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history)
- •Patient who is having an amyotrophia or joint atrophy
- •Patient who is having an disturbanace of consciousness or dysphrasia
- •Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration
- •Patient who have experienced another clinical trials within 3 months involving this clinical trial
- •Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator
结局指标
主要结局
Significant MRI Change before and after intervention
时间窗: 6 month
次要结局
- Significant Electrophysiological Change before and after intervention(6 month)
- Significant neurologic funtion Change before and after intervention(6 month)
- Adverse event(6 month)
研究者
研究点 (1)
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