Status:
UNKNOWN
Introduction of ACI for Cartilage Repair
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Articular Cartilage Defect
Chondral Defect
Eligibility:
All Genders
15-50 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04296487
Start Date
September 1 2017
End Date
September 1 2025
Last Update
December 8 2022
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Canton of Vaud, Switzerland, 1011