EUCTR2009-016970-33-CZ进行中（未招募）不适用
An Extension Protocol for Participants of Genzyme-Sponsored Prospective, Randomized,Open-Label, Parallel-Group, Multicenter Study of Matrix-Induced Autologous ChondrocyteImplantation (MACI® implant) for the Treatment of Symptomatic Articular Cartilage Defects ofthe Femoral Condyle Including the Trochlea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet the following criteria to participate in this extension study:
- •1. Received study treatment (MACI implant or microfracture) in the MACI00206 study.
- •2. Provides written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria, not applicable for this extension study.
研究者
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SUMMIT Extension StudySymptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea.Osteochondritis dissecans lesions that do not require a bone graft.MedDRA version: 18.0Level: LLTClassification code 10031231Term: Osteochondritis dissecansSystem Organ Class: 100000004859MedDRA version: 18.0Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 100000004863EUCTR2009-016970-33-SEVericel Corporation144
已完成
3 期
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