NCT01325103已完成不适用
Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury
研究概览
简要总结
This research investigates the use of autologous bone marrow stem cells in patients with spinal cord injury.
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 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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years old
- •Traumatic spinal cord injury at the thoracic or lumbar level
- •Classification Frankel A
- •Indication for spinal surgery for traumatic lesions of bone
排除标准
- •Section of the spinal anatomy
- •Open injuries
- •Active infectious diseases
- •Terminal patients
- •Neurodegenerative diseases
- •Primary hematologic diseases
- •Bone reflecting increased risk for spinal puncture
- •Coagulopathies
- •Hepatic dysfunction
- •Pregnancy
- •Other medical complications that contraindicate surgery, including major respiratory complications
- •Participation in another clinical trial
- •Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI
结局指标
主要结局
Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury
时间窗: Six months
次要结局
- Improvement of sphincters control.(Six months)
- Functional improvement in muscle strength(Six months)
研究者
Ricardo Ribeiro dos Santos
Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
Hospital Sao Rafael
研究点 (2)
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