SUMMIT Extension Study

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 -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016970-33-NL

Enrollment

142

Registered

2010-07-29

Start date

2011-03-17

Completion date

Unknown

Last updated

2012-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea. Osteochondritis dissecans lesions that do not require a bone graft. MedDRA version: 14.1 Level: LLT Classification code 10031231 Term: Osteochondritis dissecans System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10007705 Term: Cartilage damage System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Product Name: MACI Product Code: MACI Pharmaceutical Form: Implant Other descriptive name: autologous cultured human chondrocytes Concentration unit: cm2 square centimeter Concentration type: range Co

Eligibility

Sex/Gender

All

Inclusion criteria

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 142 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria, not applicable for this extension study.

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy variables • Change from MACI00206 Baseline to Weeks 24, 36, 52, 78, 104, 208 and 260 for the patient's KOOS Pain and Function (Sports and Recreational activities) scores. • Magnetic resonance imaging (MRI) assessments of structural repair parameters at Weeks 52, 104, 156 and 260 including: o Degree of defect fill based on the thickness of repair tissue; defect fill is to be regarded as the principal MRI indicator of response to treatment o Degree of integration of the repair tissue with adjacent native cartilage o Signal intensity of the repair tissue relative to adjacent native cartilage • Response rate based on KOOS Pain and Function (Sports and Recreational activities) scores: the proportion of patients who responded to treatment at Weeks 24, 36, 52, 78, 104, 156, 208 and 260. A responder is defined as a patient with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from MACI00206 Baseline (Roos, 2003, Health Qual Life Outcomes). • Treatment failure rate: the proportion of patients in each treatment group assessed as treatment failures at Weeks 24, 36, 52, 78, 104, 156, 208 and 260. • Average time to treatment failure: the time to treatment failure will be based on the date that the physician decides that surgical re-treatment of the original index lesion is required relative to the date of the original study surgery (i.e., arthroscopy for microfracture and arthrotomy for MACI implant). Treatment failure is only determined in relation to the original treated defect(s). • Change from MACI00206 Baseline at Weeks 24, 36, 52, 78, 104, 156, 208 and 260 in the remaining 3 subscales of the KOOS instrument (i.e., other Symptoms, Knee-Related Quality of Life [QOL], Activities of Daily Living [ADL]). • Change from MACI00206 Baseline at Weeks 52, 104, 156, 208 and 260 in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System. •	—

Measure

Time frame

Secondary end point(s): Secondary efficacy variables • Change from MACI00206 Baseline to Weeks 24, 36, 52, 78, 104, 208 and 260 for the patient's KOOS Pain and Function (Sports and Recreational activities) scores. • Magnetic resonance imaging (MRI) assessments of structural repair parameters at Weeks 52, 104, 156 and 260 including: o Degree of defect fill based on the thickness of repair tissue; defect fill is to be regarded as the principal MRI indicator of response to treatment o Degree of integration of the repair tissue with adjacent native cartilage o Signal intensity of the repair tissue relative to adjacent native cartilage • Response rate based on KOOS Pain and Function (Sports and Recreational activities) scores: the proportion of patients who responded to treatment at Weeks 24, 36, 52, 78, 104, 156, 208 and 260. A responder is defined as a patient with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from MACI00206 Baseline (Roos, 2003, Health Qual Life Outcomes). • Treatment failure rate: the proportion of patients in each treatment group assessed as treatment failures at Weeks 24, 36, 52, 78, 104, 156, 208 and 260. • Average time to treatment failure: the time to treatment failure will be based on the date that the physician decides that surgical re-treatment of the original index lesion is required relative to the date of the original study surgery (i.e., arthroscopy for microfracture and arthrotomy for MACI implant). Treatment failure is only determined in relation to the original treated defect(s). • Change from MACI00206 Baseline at Weeks 24, 36, 52, 78, 104, 156, 208 and 260 in the remaining 3 subscales of the KOOS instrument (i.e., other Symptoms, Knee-Related Quality of Life [QOL], Activities of Daily Living [ADL]). • Change from MACI00206 Baseline at Weeks 52, 104, 156, 208 and 260 in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System. •

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Countries

Czech Republic, Netherlands, Poland, Sweden, United Kingdom

Contacts

Public ContactMedical Information Genzyme Europe

Genzyme

eumedinfo@genzyme.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026