Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
概览
- 阶段
- 不适用
- 干预措施
- autologous chondrocytes
- 疾病 / 适应症
- Articular Cartilage Defect
- 发起方
- Centre Hospitalier Universitaire Vaudois
- 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)
- 状态
- 招募中
- 最后更新
- 上个月
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)
研究者
Dr. Robin Martin
Principal Investigator
Centre Hospitalier Universitaire Vaudois
入排标准
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
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)