Safety and Feasibility of Autologous Culture Expanded Adipose Derived Mesenchymal Stromal Cells in the Treatment of Painful Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of subjects experiencing adverse events.
研究概览
简要总结
The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal stromal cells to treat symptoms of mild to severe knee osteoarthritis.
详细描述
Interventions to alter the natural course of osteoarthritis (OA) in the knee are elusive and joint replacement remains the definitive management for refractory, end-stage disease. The Mayo Clinic has a large, ongoing experience using autologous adipose derived mesenchymal stromal cells (AMSCs) for the treatment of a variety of other diseases under INDs. Thus far, the treatments have been well tolerated. These data along with the investigators' pre-clinical animal studies and published experiences using related approaches lead the investigators to believe that this approach provides a reasonable safety profile to treat patients with refractory painful knee OA. The purpose of the current study is to investigate the safety and feasibility of single and multiple injections of autologous, culture expanded AMSCs in subjects with painful, refractory knee OA. Subjects with unilaterally symptomatic mild to severe knee OA will be enrolled based on satisfaction of inclusion and exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
S50
Subjects in the S50 cohort will receive one injection of 50 million AMSCs.
干预措施: Autologous Adipose-Derived Mesenchymal Stromal Cells (Drug)
S100
Subjects in the S100 cohort will receive one injection of 100 million AMSCs.
干预措施: Autologous Adipose-Derived Mesenchymal Stromal Cells (Drug)
M50
Subjects in the M50 cohort will receive three injections of 50 million AMSCs at one-month intervals.
干预措施: Autologous Adipose-Derived Mesenchymal Stromal Cells (Drug)
M100
Subjects in the M100 cohort will receive three injections of 100 million AMSCs at one-month intervals.
干预措施: Autologous Adipose-Derived Mesenchymal Stromal Cells (Drug)
结局指标
主要结局
Number of subjects experiencing adverse events.
时间窗: 2 years post final injection
Assess the local and systemic safety of single and multiple injections of human, autologous, culture expanded AMSCs in the treatment of symptomatic knee OA.
次要结局
未报告次要终点
研究者
Jacob L. Sellon, M.D.
Principal Investigator
Mayo Clinic
