MACI00809: An extension protocol for MACI00206

• Research type

  Research Study

• Full title

  An Extension Protocol for Participants of Genzyme-Sponsored Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of Matrix-Induced Autologous Chondrocyte Implantation (MACI® Implant) for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

• IRAS ID

  62934

• Contact name

  Andrew Price

• Sponsor organisation

  Genzyme Europe

• Eudract number

  2009-016970-33

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The objective of this study is to examine the 5-year efficacy and safety of Matrix-Induced Autologous Chondrocyte Implantation (MACI© Implant), compared with arthroscopic microfracture, in patients who received study treatment in Genzyme-sponsored study MACI00206 for treatment of symptomatic articular cartilage defects of the femoral condyle, including the trochlea. This is an open-label, multicenter, 3-year extension study for patients who received study treatment (MACI implant or microfracture) in the MACI00206 study. Patients who have participated in MACI00206 study are to be told details of this extension study and be provided with a copy of the informed consent form (ICF) before or during their MACI00206 last visit. Efficacy and safety assessments will be performed at scheduled visits 3, 4 and 5 years following treatment in MACI00206 (i.e., at Weeks 156, 208 and 260 post-arthrotomy for patients treated with MACI implant or at Weeks 156, 208 and 260 post arthroscopy for patients treated with microfracture). Patients’ MACI00206 data will be utilized for statistical analysis (e.g., for treatment failure analysis) in this extension study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/69

• Date of REC Opinion

  26 Jan 2011

• REC opinion

  Further Information Favourable Opinion