New data from Phase III extension study of MACI (autologous chondrocyte implant) in Tissue Repair- Vericel Corp

Vericel Corporation has reported positive results from the three-year extension of the Phase III SUMMIT study with MACI (matrix-applied characterized autologous cultured chondrocytes) in patients with symptomatic articular cartilage defects in the knee. In the open-label, multi-center study, 144 patients were randomized to receive treatment with MACI implant or microfracture bone marrow stimulation (MFX) and followed for two years.

The study found that treatment with MACI was clinically and statistically significantly better than MFX, with similar structural repair tissue and safety. The co-primary endpoints of the extension study are change in knee injury and osteoarthritis outcome (KOOS) pain and function scores at year 3, the same primary endpoint from the two-year SUMMIT trial.

Patients treated with MACI versus MFX continue to show a statistically significant improvement from baseline in the co-primary endpoint of KOOS pain and function at year 3 with higher responder rates in the MACI group (81.5%) than in the MFX group (66.7%). Patients treated with MACI versus MFX also showed significant improvement in knee-related quality of life and other measures. Data were presented at the annual meeting of the American Association of Orthopedic Surgeons.