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CS-ACI for Articular Cartilage Defects
NCT01694823Phase 2
Key facts
- Status
- Unknown
- Start
- Apr 2012
- Primary completion
- Jul 2013
- Countries
- 1
- Modality
- Cell Therapies
- Conditions
- Articular cartilage defect
01
Overview
Phase 2, open-label, single-arm trial of cell sheet-autologous chondrocyte implantation in Articular cartilage defect. Primary endpoint: Mean change from baseline in the MRI at 24 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
CS-ACI
Autologous chondrocyte sheet implantation
03
Who it enrols
Patients with isolated ICRS grade III or IV single defect chondral lesions on Articular Cartilage (size 2.5 to < 5 cm2). Excludes patients with obesity, arthritis, arthrofibrosis, ankylosis, or infectious diseases.
04
Endpoints
Primary
Mean change from baseline in the MRI
Secondary
Change from Baseline in the Lysholm Score
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score
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