NCT01513694已完成1 期
Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
- •Discopathy refractory to conservative treatment (drugs, physical therapy.)
- •Evolution greater than or equal to 6 months. Radiological
- •Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
- •NMR: grades IV and V of Pfirman.
排除标准
- •Rejection of surgical treatment.
- •Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
- •Immunosuppressive treatment.
- •Congenital or acquired anatomical abnormality that prevents the surgical procedure.
- •Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
- •High surgical risk (ASA> IV), or contraindication to anesthesia.
研究组 & 干预措施
MSC seeded onto a phosphate ceramic
Experimental
Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.
干预措施: Instrumented posterolateral arthrodesis (Procedure)
研究者
研究点 (1)
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