A Multi-Center, Active-Controlled, Open-Label, Phase III Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patients With Knee Chondral Defects
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 18
- 主要终点
- MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
研究概览
简要总结
To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration.
详细描述
This open-label, phase 3 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) compared with microfracture surgery in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following:
- •Patients over the age of
- •Defect size: 2 to 10 cm^2 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 with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 ~ 2).
- •Patients with a KOOS total score below
- •Patients able to walk without aid.
- •Patients who agree to abide by rehabilitation protocols and follow-up programs, including residential exercise routines.
- •Patients who provide written consent to the application of the clinical trial.
排除标准
- •Individuals who meet any of the following will be excluded from participation in this study:
- •Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
- •Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
- •Patients with inflammatory articular diseases related to autoimmune diseases.
- •Patients hypersensitive to bovine derived proteins or any of the components in this product.
- •Patients hypersensitive to Gentamycin.
- •Patients with Haemophilia or markedly reduced immune function.
- •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, or nursing a baby.
- •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®
Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.
干预措施: Autologous Chondrocyte Implantation (CartiLife®) (Drug)
Microfracture Surgery
Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.
干预措施: Microfracture Surgery (Procedure)
结局指标
主要结局
MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
时间窗: At Week 48, post-operation
MOCART is a validated tool that provides reliable, reproducible, and accurate assessment of cartilage repair tissue (Marlovits et al, 2006 that; Trattnig et al, 2011).
KOOS Total Score
时间窗: From Week 0 to Week 48, post-operation
The KOOS is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). In the 'Knee injury and Osteoarthritis Outcome Score', scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
次要结局
- Pain medication history(At Week 0 to Week 8, 24, 48 and 96, post-operation)
- MOCART Score(At Week 24 and Week 96, post-operation)
- Lysholm Score(At Week 0 to Week 8, 24, 48 and 96, post-operation)
- IKDC Score(At Week 0 to Week 8, 24, 48 and 96, post-operation)
- KOOS Score (Pain, Other symptoms, Function in daily living, Function in sport and recreation, and knee-related QOL subscales)(At Week 0 to Week 8, 24, 48 and 96, post-operation)
- VAS (100mm Pain Visual Analogue Scale)(At Week 0 to Week 8, 24, 48 and 96, post-operation)
- Tegner Activity Scale(At Week 0 to Week 8, 24, 48 and 96, post-operation)
- Treatment related adverse events(At Week 0 (pre-operation), and up to 24 Months (post-operation))