A Prospective Randomized Open-label Parallel-group Multi-center Study to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACI) Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

Trial Profile

A Prospective Randomized Open-label Parallel-group Multi-center Study to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACI) Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

  • Drugs Autologous cultured chondrocytes (Primary)
  • Indications Knee injuries
  • Focus Registrational; Therapeutic Use
  • Acronyms SUMMIT
  • Sponsors Genzyme Corporation; Vericel Corporation
  • Most Recent Events

    • 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.
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