Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee

NCT00719576 ↗

Phase 3 Completed 144 enrolled Vericel Corporation

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

Timeline

Start: 2008-07
Primary completion: 2012-03
Completion: 2012-03

Outcome

Met primary endpoint

registry analysis (superiority test); MACI vs Microfracture; p = 0.001; MANOVA NCT00719576 ↗

paper The mean KOOS pain and function subscores from baseline to 2 years were significantly more improved with MACI than with MFX PMID 24714783 ↗

Publications

Results Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, Emans P, Podskubka A, Tsuchida A, Kili S, Levine D, Brittberg M; SUMMIT study group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2014 Jun;42(6):1384-94. doi: 10.1177/0363546514528093. Epub 2014 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MACI	Cell therapy	—	Other