Introduction of ACI for Cartilage Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-50
SponsorCentre Hospitalier Universitaire Vaudois
About this trial
This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Body mass index (BMI) of 35 or more
Osteoarthritis or rheumatoid arthritis
Diffuse lesion
Uncorrected mal-alignment, ligamentous instability, or meniscal tear
Trial design
Design model
Single group
Treatments tested in this trial
autologous chondrocytes
Other interventionautologous chondrocytes implantation (ACI)
Treatment groups
218 Participants
are divided into 1 treatment groupGroup A: Autologous Chondrocyte InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 12 months.2
Change in tissue integrity into and around the treated aera
MRI analysis
Time frame
3 months post-implantation3
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%.
Time frame
6 weeks post-implantationSecondary outcomes
1
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).
Time frame
Change from baseline to 12 months post-implantation.2
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).
Time frame
Change from baseline to 12 months post-implantation3
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).
Time frame
Change from baseline to 12 months post-implantation4
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)
Time frame
Change from baseline to12 months post-implantationSponsors and contacts
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Source ClinicalTrials.gov