Introduction of ACI for Cartilage Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: autologous chondrocytes.
- Who it may be relevant to
- Registry conditions: Articular Cartilage Defect, Chondral Defect, Osteochondritis. Basic parameters: 15 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
Overview
This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.
Detailed description
* 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)
Interventions
- Other autologous chondrocytes
autologous chondrocytes implantation (ACI)
Primary outcome measures
- Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) [Time frame: Up to 12 months.]
- Change in tissue integrity into and around the treated aera [Time frame: 3 months post-implantation]
- Absence of infection after implantation. [Time frame: 6 weeks post-implantation]
Secondary outcome measures (4)
- Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Change from baseline to 12 months post-implantation.]
- Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC) [Time frame: Change from baseline to 12 months post-implantation]
- Self-reported functional health and weel-being as assessed by SF12 Survey [Time frame: Change from baseline to 12 months post-implantation]
- The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system. [Time frame: Change from baseline to12 months post-implantation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Centre Hospitalier Universitaire Vaudois - CHUV — Lausanne
Identifiers
NCT: NCT04296487 · ACI-OTR