A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Comparison of treatment adverse event rates
研究概览
简要总结
The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).
详细描述
The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have received an injection in Protocol No. 550
- •Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
- •Subject must provide written informed consent for entry into the extension study
- •Subject must provide authorization for use and disclosure of protected health information for entry into the extension study
排除标准
- 未提供
研究组 & 干预措施
A
Chondrogen (low dose)
干预措施: Chondrogen (Drug)
B
Chondrogen (high dose)
干预措施: Chondrogen (Drug)
C
Hyaluronan
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of treatment adverse event rates
时间窗: Through 3 years
次要结局
- Concomitant Medications(Through 3 years)
- Visual Analog Scale(Through 3 years)