NCT00548119已完成2 期
A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
Histogenics Corporation8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.
研究概览
简要总结
The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.
排除标准
- •Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.
结局指标
主要结局
The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.
时间窗: One year
次要结局
- This study will extend the experience derived from our Phase 1 study.(One year)
研究者
研究点 (8)
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