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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2017

At a glance

  • Drugs Autologous cultured chondrocytes (Primary)
  • Indications Cartilage disorders
  • Focus Therapeutic Use
  • Sponsors Genzyme Corporation
  • Most Recent Events

    • 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.
    • 04 Mar 2016 According to a Vericel Corporation media release, the company has submitted a Biologics License Application (BLA) to the US FDA for MACI for the treatment of symptomatic cartilage defects of the knee in adults.
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