Genzyme completes recruitment and treatment in clinical trial comparing MACI and microfracture

Genzyme Biosurgery, a division of Genzyme Corp., announced in a press release the completion of patient enrollment and surgical treatment in the SUMMIT trial.

SUMMIT is a prospective, randomized controlled clinical trial designed to demonstrate the superiority of MACI (Matrix-induced Autologous Chondrocyte Implantation) vs. microfracture for the treatment of symptomatic cartilage injuries in the knee. There are 144 patients enrolled in the trial across seven countries in Europe, the company noted.

The primary endpoint of SUMMIT is an assessment of patients’ knee pain symptoms and function from baseline to 2 years after treatment. Secondary end points include the assessment of tissue repair quality as measured by MRI and cartilage biopsies. Safety assessments are ongoing throughout the trial.

“SUMMIT is one of most rigorous clinical trials in the field of cartilage repair,” stated Daniel Saris, MD, PhD, orthopedic surgeon at the University Medical Center Utrecht and professor of /reconstructive medicine University Twente, in the Netherlands. “It is quite an accomplishment that Genzyme and investigators have been able to enroll such a large number of patients so quickly. The results of this trial will impact the advancement of cartilage repair and are eagerly awaited by the orthopaedic community, particularly those specializing in cartilage repair.”

To qualify for the study patients were diagnosed with at least one full-thickness defect of the femoral condyle (including trochlea) greater than or equal to 3 cm². Qualifying patients also reported significant pain and impairment associated with their cartilage injury. Patients were enrolled at study sites in the Czech Republic, France, the Netherlands, Norway, Poland, Sweden and the United Kingdom.

“Genzyme has long been a pioneer in the field of innovative biotechnology, including cell therapy and cartilage repair technology,” Leanna Caron, vice president and general manager of Cell Therapy and Regenerative Medicine, a business of Genzyme Corporation, stated in the release. “Upon approval, MACI will represent a significant advancement in surgical delivery that will provide orthopedic surgeons with a convenient and minimally invasive delivery of autologous cultured chondrocytes. We thank the principal investigators and their study site staff for their efforts in enrolling and following patients in this major trial. We look forward to the outcome of SUMMIT and expect it will support global registration for MACI.”