Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 主要终点
- Knee Function Change and Improvement
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.
详细描述
Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose lesion (single joint) should be in the range of 2 cm^2-8 cm^
- •Patients with pain in affected joint of 60 mm- 100 mm VAS (visual analogue scale)
- •Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
- •Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
- •Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
- •Patients voluntarily agreed to participate in the study and signed informed consent
排除标准
- •Patients with autoimmune diseases or medical history
- •Patients with infections requiring injection of antibiotics
- •Patients with severe internal diseases
- •Patients who are currently pregnant or lactation
- •Patients who had participated in any other clinical trials within the past four weeks
- •Patients who had been administered with immunosuppressants within the past four weeks
- •Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
结局指标
主要结局
Knee Function Change and Improvement
时间窗: 12 months after treatment
Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
次要结局
- Severity of adverse events(12 months)