SUMMIT Extension Study

Conditions: Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea.Osteochondritis dissecans lesions that do not require a bone graft.
MedDRA version: 18.0Level: LLTClassification code 10031231Term: Osteochondritis dissecansSystem Organ Class: 100000004859
MedDRA version: 18.0Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2009-016970-33-SE

Lead Sponsor: Vericel Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 144

Inclusion Criteria

Patients must meet the following criteria to participate in this extension study:
1. Received study treatment (MACI implant or microfracture) in the MACI00206 study.
2. Provides written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria, not applicable for this extension study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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<br>cartilage defects of the femoral condyle, including the trochlea.;Secondary Objective: Not Applicable;Primary end point(s): Efficacy will be assessed by evaluation of:<br>•Co-primary efficacy variable<br>Change from MACI00206 Baseline to Week 156 for the patient's Knee<br>Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function<br>(Sports and Recreational activities) scores.;Timepoint(s) of evaluation of this end point: 156 weeks

Secondary Outcome Measures