NCT01694927Unknown2 期
Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
Clínica Las Condes. LIT INNOVA CORFO2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
研究概览
简要总结
The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells intralesional transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Spinal Injury Association Impairment (ASIA) Scale A, B and C
- •Cervical (under C4), thoracic o lumbar spine lesion
- •Complete or Incomplete SCI
- •Platelet count over 100.000/ul
排除标准
- •Acute SCI (less than 3 months)
- •Active infectious diseases
- •Pregnancy
- •Neurodegenerative diseases
- •Primary hematologic diseases
- •Coagulopathies
- •Hepatic dysfunction
- •Pregnancy
结局指标
主要结局
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
时间窗: 3 months
次要结局
- Functional improvement in muscle strength(1 year)
- Functional Improvement in sphincters control(1 year)
- Functional improvement in spasticity control(1 year)
研究者
Clínica Las Condes. LIT INNOVA CORFO
Clinical Researcher LIT. Innova CORFO 09IEI6568
Clinica las Condes, Chile
研究点 (2)
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