NCT04296487 Introduction of ACI for Cartilage Repair
| NCT ID | NCT04296487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Vaudois |
| Condition | Articular Cartilage Defect |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2017-09-01 |
| Primary Completion | 2030-09 |
Trial Parameters
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Brief Summary
This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.
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