NCT01643681撤回不适用
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
R-Bio2 个研究点 分布在 2 个国家开始时间: 2012年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Magnetic Resonance Imaging
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with lumbar intervertebral disc degeneration.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who understand and sign the consent form for this study
- •Age :19-70, males and females
- •Have chronic low back pain for at least 1 year
- •Have failed 1 year of non-operative low back pain management
- •Have degenerated intervertebral disc on T2-weighted MR images
- •confirmed by positive discography
- •Have significant lumbar instability at degenerated intervertebral disc
排除标准
- •Have significant lumbar herniated intervertebral disc
- •Women who are pregnant or breast feeding or planning to become pregnant during the study
- •History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
- •Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus
- •Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
结局指标
主要结局
Magnetic Resonance Imaging
时间窗: 24 weeks
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs.
次要结局
- Changes of Neurological Functions(24 weeks)
- Safety evaluation(24 weeks)
研究者
研究点 (2)
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