NCT03545269已完成2 期
A Multi-Center, Active-Controlled, Open-Label, Phase Ⅱ Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patient With Chondral Defects in the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
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 chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 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
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged between 19 and 65
- •Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
- •Defect: isolated International Cartilage Repair Society(ICRS) 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
- •Kellgren and Lawrence grade ≥ 3
- •Patients with arthritis associated with autoimmune diseases
- •Patients hypersensitive to bovine protein
- •Patients with Haemophilia or markedly reduced immune function
- •Patients hypersensitive to antibiotics like 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®
Experimental
干预措施: CartiLife® (Drug)
Microfracture
Active Comparator
干预措施: Microfracture (Procedure)
结局指标
主要结局
MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
时间窗: Baseline to 48 weeks
Changes in MOCART scores during each visit
次要结局
- IKDC (International Knee Documentation Committee Score)(Baseline to 48 weeks)
- VAS (100 mm Pain Visual Analogue Scale)(Baseline to 48 weeks)
- ROM (Range Of Motion)(Baseline to 48 weeks)
- X-ray(Baseline to 48 weeks)
- Lysholm Score(Baseline to 48 weeks)
- KOOS (Knee injury Osteoarthritis Outcome Score)(Baseline to 48 weeks)
- Adverse events(Baseline to 48 weeks)
研究者
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