EUCTR2015-005162-34-HR
Active, not recruiting
Phase 1
Randomized, multi-center phase II clinical trial for the regeneration of cartilage lesions in the knee using nasal chondrocyte-based tissue (NTEC) or nasal chondrocyte-based cell (N-CAM)-therapies - Nose to Knee II
niversity Hospital Basel0 sites108 target enrollmentDecember 15, 2016
ConditionsPatients must display 1-2 symptomatic, focal cartilage lesion grade IIIIV(according to the grading by the International Cartilage RepairSociety (ICRS)) from 2 to 8 cm2 on the femoral condyle and/or thetrochlea, have to be between 18-65 years old and must consent in oraland written manner in order to be enrolled in the study.Therapeutic area: Not possible to specify
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients must display 1-2 symptomatic, focal cartilage lesion grade IIIIV(according to the grading by the International Cartilage RepairSociety (ICRS)) from 2 to 8 cm2 on the femoral condyle and/or thetrochlea, have to be between 18-65 years old and must consent in oraland written manner in order to be enrolled in the study.
- Sponsor
- niversity Hospital Basel
- Enrollment
- 108
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is \=18 and \=65 years old at time of screening.
- •Patient has a localized articular cartilage defect of the femoral
- •condyle and/or the trochlea of the knee. 2 localized cartilage defects
- •are accepted if the total defect size is \= 8 cm2, both cartilage defects
- •are located at the femoral condyle and/or the trochlea and both
- •cartilage defects are to be treated with N\-CAM or N\-TEC.
- •Patient has a defect of grade 3 or 4 according to the ICRS
- •classification.
- •Patient has a defect size \=2 and \=8 cm2 as assessed by
- •MRI/arthroscopy.
Exclusion Criteria
- •Patient is unable to understand the patient information
- •Patient is unable to undergo magnetic resonance imaging (MRI) or
- •is sensitive to gadolinium
- •Patient has had prior surgical treatment of the target knee within 12
- •months using mosaicplasty and/or microfracture (Note: prior
- •diagnostic arthroscopy with debridement and lavage are acceptable
- •within 12 months). Anterior cruciate ligament repair is accepted, if the
- •target knee is stable or a primary ACL reconstruction is performed
- •within 6 weeks of the planned cartilage treatment.
- •Patient has an onset of symptoms of \> 5 years.
Outcomes
Primary Outcomes
Not specified
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