Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-09-01
2025-09-01
Brief Summary
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Detailed Description
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* 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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous Chondrocyte Injection
Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10\^6 of cells per cm\^2 of the cartilage defect.
autologous chondrocytes
autologous chondrocytes implantation (ACI)
Interventions
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autologous chondrocytes
autologous chondrocytes implantation (ACI)
Eligibility Criteria
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Inclusion Criteria
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
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
15 Years
50 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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Dr. Robin Martin
Principal Investigator
Principal Investigators
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Robin MARTIN, MD
Role: PRINCIPAL_INVESTIGATOR
CHUV
Locations
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Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ACI-OTR
Identifier Type: -
Identifier Source: org_study_id
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