A Prospective, Randomized, Open-label, Parallel-group, Multi-center Study to Demonstrate the Superiority of MACI® Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.
Phase of Trial: Phase III
Latest Information Update: 18 Dec 2017
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At a glance
- Drugs Autologous cultured chondrocytes (Primary)
- Indications Knee injuries
- Focus Registrational; Therapeutic Use
- Acronyms SUMMIT
- Sponsors Genzyme Corporation; Vericel Corporation
- 14 Dec 2016 According to a Vericel Corporation media release, the US FDA has approved MACI for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults based on results from his trial.
- 10 May 2016 According to a Vericel Corporation media release, the US FDA has accepted for review the BLA for MACI with a PDUFA goal date of January 3, 2017.
- 14 Mar 2016 According to a Vericel Corporation media release, the US FDA has accepted for filing a Biologics License Application (BLA) for MACI for the treatment of symptomatic cartilage defects of the knee in adults.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History