NCT01251588

Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 128 (actual)
• Sponsor: Vericel Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.

Detailed description

This study was an open-label, multicenter extension to the SUMMIT study designed to examine the 5-year efficacy and safety of MACI compared to arthroscopic microfracture in the treatment of articular cartilage defects of the knee in participants who received study treatment in the SUMMIT study. Follow-up to 2 years post-study treatment was completed as part of the SUMMIT study. Follow-up from 3 to 5 years post-study treatment in SUMMIT was completed in this extension study. All 144 participants who received study treatment in the SUMMIT study were eligible for enrollment into this extension study. Participants had until the end of the visit window for the last visit of this extension study (ie, Week 260 + 6 weeks) to consent to enter this extension study. Efficacy and safety assessments were performed at scheduled visits 3, 4, and 5 years following treatment in SUMMIT (ie, at Weeks 156, 208, and 260 postarthrotomy for patients treated with MACI implant or at Weeks 156, 208, and 260 postarthroscopy for patients treated with microfracture).

Conditions

• Articular Cartilage Defects

Interventions

Type	Name	Description
BIOLOGICAL	autologous cultured chondrocytes on porcine collagen membrane	Implantation received in the previous MACI00206 study
PROCEDURE	Microfracture	Arthroscopic Microfracture treatment received in the previous MACI00206 study

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-12-02
• Last updated: 2021-05-12
• Results posted: 2017-04-27

Locations

14 sites across 7 countries: Czechia, France, Netherlands, Norway, Poland, Sweden, United Kingdom