An Extension Protocol for Participants of Genzyme-Sponsored Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of MACI for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea
Phase of Trial: Phase III
Latest Information Update: 02 Nov 2018
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At a glance
- Drugs Autologous cultured chondrocytes (Primary)
- Indications Cartilage disorders
- Focus Therapeutic Use
- Sponsors Genzyme Corporation; Vericel Corporation
- 23 Mar 2018 According to a Vericel Corporation media release, results were published in the American Journal of Sports Medicine.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History