BRIDGEWATER, N.J., July 12, 2012 /PRNewswire/ -- Sanofi US announced today that its product MACI® (matrix-induced autologous chondrocyte implant) met its co-primary endpoint in a two-year, randomized, controlled clinical trial compared to microfracture, a surgical procedure designed to stimulate the growth of new cartilage. MACI uses a patient's own (autologous) cultured cartilage cells (chondrocytes) to repair articular cartilage defects in the knee joint. The results from this pivotal safety and efficacy phase 3 trial comparing MACI to microfracture (SUMMIT) will be included as part of an ongoing EMA marketing authorization application and as part of a future FDA biologics license application in the United States.
The trial enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in their knees. Analysis of the clinical data showed a statistically significant improvement in the primary endpoint for those patients treated with MACI compared to microfracture. In addition, this difference met the pre-specified threshold for a clinically meaningful difference.
"MACI may offer orthopaedic surgeons an advanced, minimally invasive product to treat patients with debilitating knee pain from articular cartilage injuries in the knee," said Leanna Caron, Vice President and General Manager of Sanofi Biosurgery's Cell Therapy and Regenerative Medicine Division. "Successful treatment can significantly reduce pain and permit patients to regain function. The success of the SUMMIT trial is an important step to support our ongoing EMA marketing authorization application and a future FDA biologic license application in the United States which would be the next step in bringing this next generation of cartilage repair therapy to patients in the United States."The data from the study will be shared at a major scientific meeting and published in a prominent medical journal early next year.
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