A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Recording of Serious Adverse Events
研究概览
简要总结
Primary:
To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).
Secondary:
To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.
排除标准
- •Any disease or medication affecting the bone or cartilage metabolism, including corticoids.
研究组 & 干预措施
Group 1
2 x 10E6 ASC intra-articular injection (5 ml)
干预措施: Autologous adipose derived stem cells administrated for intra-articular use (Biological)
Group 2
10 x 10E6 ASC intra-articular injection (5 ml)
干预措施: Autologous adipose derived stem cells administrated for intra-articular use (Biological)
Group 3
50 x 10E6 ASC intra-articular injection (5 ml)
干预措施: Autologous adipose derived stem cells administrated for intra-articular use (Biological)
结局指标
主要结局
Recording of Serious Adverse Events
时间窗: during 365 days following injection
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.
次要结局
- Functional status of the knee(during 365 days following injection)
- Evaluation of Quality of life(during 365 days following injection)