Genzyme Completes Recruitment and Treatment of Patients in Large, Multicenter, Randomized Phase III Clinical Trial
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Trial Compares MACI Implant to Microfracture Procedure
CAMBRIDGE, Mass. – Genzyme Biosurgery, a division of Genzyme Corp., announced today 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) versus 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 primary endpoint of SUMMIT is an assessment of patients’ knee pain symptoms and function from baseline to two 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,” said Daniel Saris, orthopaedic surgeon at the University Medical Center Utrecht and Professor of Reconstructive Medicine University Twente, 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 three cm² in size. 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,” said Leanna Caron, Vice President and General Manager of Cell Therapy and Regenerative Medicine, a business of Genzyme Corporation. “Upon approval, MACI will represent a significant advancement in surgical delivery that will provide orthopaedic 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.”
Cell Therapy Expertise at Genzyme
Genzyme has more than a decade of experience in cell therapy and offers three cell-based products, each pioneering in their own right, that demonstrate Genzyme’s superior scientific and commercial expertise in the cell therapy field. These products include cell therapy products for cartilage damage and a cell therapy product to treat patients with life-threatening burns.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Sarah Connors
Corporate Communications
Genzyme Corporation | Genzyme Center | 500 Kendall Street | Cambridge, MA 02142
Tel: 617 768 6438 | Email: sarah.connors@genzyme.com
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25 / 05 / 2010 - Genzyme - Clinical Trial Results