At a glance
ClinicalIndex Comparison RecordN/ACompleted· 128 enrolled
Drug / intervention
autologous cultured chondrocytes on porcine collagen membrane +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating autologous cultured chondrocytes on porcine collagen membrane and Microfracture for Articular Cartilage Defects. Completed, enrolled 128 participants across 14 sites in 7 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsArticular Cartilage Defects
CountriesCzechia, France, Netherlands, Norway, Poland, Sweden, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedDec 2010
Primary CompletionMar 2015
TodayJul 2026
First PostedDec 2, 2010
Enrollment StartDec 1, 2010
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.6 years ago
Interventions
autologous cultured chondrocytes on porcine collagen membranebiological
Implantation received in the previous MACI00206 study
Microfractureprocedure
Arthroscopic Microfracture treatment received in the previous MACI00206 study