Introduction of ACI for Cartilage Repair

Study Overview
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Brief Summary
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This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.

Detailed Description
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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)

Official Title
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Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee

Conditions
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Articular Cartilage Defect, Chondral Defect, Osteochondritis

Intervention / Treatment
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* Other: autologous chondrocytes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 15 and 50. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Chondrocyte Injection<br>Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect. | Other: autologous chondrocytes<br>* autologous chondrocytes implantation (ACI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) | Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage reparation). | Up to 12 months. | 
| Change in tissue integrity into and around the treated aera | MRI analysis | 3 months post-implantation | 
| Absence of infection after 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%. | 6 weeks post-implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS) | KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score). | Change from baseline to 12 months post-implantation. | 
| Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC) | A score will be calculated, and it ranges from 0 (worst score) to 100 (best score). | Change from baseline to 12 months post-implantation | 
| Self-reported functional health and weel-being as assessed by SF12 Survey | SF12 survey includes 2 subscales: mental component summary (MCS) and physical component summery (PCS). A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score). | Change from baseline to 12 months post-implantation | 
| The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system. | MOCART scoring system is based on MRI analysis. A score in points will be calculated, and it ranges from 0 points (no repair) to 100 points (excellent cartilage defect repair) | Change from baseline to12 months post-implantation |