Clinical trial NCT04296487: Introduction of ACI for Cartilage Repair
Official title: Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Articular Cartilage Defect
Chondral Defect
Osteochondritis
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)

Eligibility criteria: Inclusion Criteria:

1. Age between 15 and 50.
2. Lesions classified as ICRS Grade III or IV and smaller than 15 cm2
3. Lesions that have failed prior therapy (conservative or surgical treatment ≥ six months)
4. Subjects who understand and sign the consent form for this study

Exclusion Criteria:

1. Body mass index (BMI) of 35 or more
2. Osteoarthritis or rheumatoid arthritis
3. Diffuse lesion
4. Uncorrected mal-alignment, ligamentous instability, or meniscal tear
5. Presence of growth cartilage (15-18 years old)
6. Active smoking or drug consumption
7. Women who are pregnant
8. Positive serology for HIV-1 or HIV-2, Hepatitis B and C and syphilis
9. Proven allergy to porcine collagen, penicillin and gentamicin
10. Poor compliance

Primary outcomes:
measure: Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)
timeFrame: Up to 12 months.
measure: Change in tissue integrity into and around the treated aera
timeFrame: 3 months post-implantation
measure: Absence of infection after implantation.
timeFrame: 6 weeks post-implantation
Secondary outcomes:
measure: Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Change from baseline to 12 months post-implantation.
measure: Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC)
timeFrame: Change from baseline to 12 months post-implantation
measure: Self-reported functional health and weel-being as assessed by SF12 Survey
timeFrame: Change from baseline to 12 months post-implantation
measure: The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system.
timeFrame: Change from baseline to12 months post-implantation
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - CHUV
state: Vaud
Study officials:
affiliation: CHUV
name: Robin MARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: