Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)
研究概览
简要总结
This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.
详细描述
- Prospective and interventional study
- All procedures are carried out after obtaining informed written consent from patients.
- Study procedures involve a biopsy, cell production, cell implantation and follow-up including a strict post-surgery rehabilitation protocol (12 month timepoint)
- All subjects will be assessed at intervals post-implantation (6 weeks, 3 months, 6 months and 12 months).
- Measures to assess effectiveness and safety will be conducted at follow-ups: Magnetic Resonance Imaging (MOCART score), collection of adverse events, orthopaedic scores (KOOS, IKDC, SF12v2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 15 and
- •Lesions classified as ICRS Grade III or IV and smaller than 15 cm2
- •Lesions that have failed prior therapy (conservative or surgical treatment ≥ six months)
- •Subjects who understand and sign the consent form for this study
排除标准
- •Body mass index (BMI) of 35 or more
- •Osteoarthritis or rheumatoid arthritis
- •Diffuse lesion
- •Uncorrected mal-alignment, ligamentous instability, or meniscal tear
- •Presence of growth cartilage (15-18 years old)
- •Active smoking or drug consumption
- •Women who are pregnant
- •Positive serology for HIV-1 or HIV-2, Hepatitis B and C and syphilis
- •Proven allergy to porcine collagen, penicillin and gentamicin
- •Poor compliance
研究组 & 干预措施
Autologous Chondrocyte Injection
Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect.
干预措施: autologous chondrocytes (Other)
结局指标
主要结局
Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)
时间窗: Up to 12 months.
Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage reparation).
Change in tissue integrity into and around the treated aera
时间窗: 3 months post-implantation
MRI analysis
Absence of infection after implantation.
时间窗: 6 weeks post-implantation
Absence of infection is assessed in blood sample by the quantification of three parameters: C-reactive Protein (CRP), neutrophil and lymphocyte rate. The non-infection is characterised by a CRP rate \< 10 mg/L, neutrophil rate ranges from 40-75% and lymphocyte rate ranges from 25-40%.
次要结局
- Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS)(Change from baseline to 12 months post-implantation.)
- Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC)(Change from baseline to 12 months post-implantation)
- Self-reported functional health and weel-being as assessed by SF12 Survey(Change from baseline to 12 months post-implantation)
- The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system.(Change from baseline to12 months post-implantation)
研究者
Dr. Robin Martin
Principal Investigator
Centre Hospitalier Universitaire Vaudois