NCT03517046已完成1 期
A Multi-center, Open-label, Phase I Trial to Assess the Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife for Patients With Chondral Defects in the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 19 years old
- •Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
- •Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage
- •The joint space is maintained over 50% relative to baseline
- •Patients that are able to walk without aid
- •Patients that agree to abide by strict rehabilitation protocols and follow-up programs
- •Patients who provide written consent to the participation of the clinical trial
排除标准
- •Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
- •Patients with arthritis associated with autoimmune disease
- •Patients hypersensitive to bovine protein
- •Patients with Haemophilia or markedly reduced immune function
- •Patients hypersensitive to antibiotics such as gentamicin
- •Patients with arterial bleeding and severe venous bleeding
- •Patients with other diseases including tumors except for cartilaginous defects of joints
- •Patients with a history of radiation treatment and chemotherapy within the past two years
- •Patients who are pregnant, nursing a baby or likely to get pregnant
- •Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
- •Other cases where the investigator deems the patient ineligible for participation
研究组 & 干预措施
CartiLife (low-dose group)
Experimental
Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed.
干预措施: CartiLife (Drug)
CartiLife (high-dose group)
Experimental
Total defect volume in High-dose group is 2 ~ 4 ㎤.
干预措施: CartiLife (Drug)
结局指标
主要结局
Adverse events
时间窗: 48 weeks
Number of adverse events
次要结局
- IKDC (International Knee Documentation Committee)(Baseline to 48 weeks)
- X-ray(Baseline 48 weeks)
研究者
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