Genzyme Introduces Unique, Novel Technology to Further Demonstrate Quality of its Cartilage Repair Products
Science Awarded at Recent ICRS Meeting
Genzyme Corporation announced that it has developed unique, proprietary methods for the characterization of chondrocytes cells, which are found in articular cartilage. This breakthrough development will be used in the production of its MACI® implants and Carticel® cultured human chondrocytes, the company’s two autologous chondrocyte implantation (ACI) products used to replace damaged knee cartilage. The innovative methods establish additional high-quality measures to further identify and validate the quality and vitality of the cells produced for implantation.
Scientists at Genzyme have identified unique ways to substantiate the cell purity of their final implant products as well as confirm the potential for these cells to create tissue with properties similar to that of hyaline tissue, the articular cartilage tissue. These innovations were recently recognized by a panel of independent scientists and clinicians at the International Cartilage Repair Society (ICRS) meeting in Warsaw, Poland, where they were granted scientific awards. Out of a total of 246 abstracts presented at the meeting, two of Genzyme’s abstracts were amongst the 10 to receive the Cum Laude award by the Scientific Program Committee.
“Genzyme has long been a pioneer in the field of innovative biotechnology, including cell therapy and cartilage repair technology,” said Ann Merrifield, president of Genzyme Biosurgery, a business unit of Genzyme Corporation. “We are quite proud of our scientists for continuing to innovate and enhance our existing therapies. These scientific measures demonstrate our commitment to this market as we continue to set excellence in manufacturing standards to ensure that patients receive the highest quality product.”
MACI (Matrix-assisted Autologous Chondrocyte Implantation) is marketed in Europe, Asia and Australia while Carticel (autologous cultured chondrocytes) is marketed in the United States.
The two abstracts receiving the Cum Laude Award are:
“Identification of dedifferentiated chondrocytes using gene expression – the dcs assay”, which describes how the authors were able to identify genomic markers that discriminate between chondrocytes and other closely-related cells to control the quality of chondrocytes manufactured for the repair of cartilage defects. “DNA methylation study of chondrocytes and synovial fibroblast cultures”, which describes a proprietary chondrocyte rapid-identification assay that distinguishes chondrocytes from other cell types.
Genzyme has over 20 years of clinical experience in developing and producing autologous cell therapy products that meet the highest standards of quality and compliance. In July 2007, Genzyme announced data from the Study of the Treatment of Articular Repair (STAR), which demonstrated that Carticel cultured chondroncytes provided sustained and clinically meaningful improvements in knee function and reduction in knee pain. Data from this study were also presented at the ICRS meeting last month.
In another study, the MACI implant was demonstrated to have the ability to generate hyaline-like cartilage as early as six months after implantation1.
With more than 20,000 patients treated globally, MACI implants and Carticel cultured chondrocytes - Genzyme’s first-generation ACI - are used by orthopaedic surgeons to treat patients who have clinically significant articular cartilage lesions. They employ the patient’s own cartilage cells to grow new cells for implantation to correct damage. The Carticel procedure was the first cell therapy ever approved by the FDA.
About MACI implants
The MACI implant (Matrix-induced Autologous Chondrocyte Implant) is an autologous cartilage repair treatment for articular cartilage defects in symptomatic patients. The MACI implant has been predominantly administered in the knee joint and is available in Europe and Australasia.
The MACI implant is produced in Genzyme’s GMP-certified laboratories in Copenhagen, Denmark, where it is compliant with all applicable European directives, and in Perth, Australia, servicing Australasia.
About Carticel chondrocyte implantation
Carticel chondrocyte implantation is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). Carticel implantation should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with Carticel implantation.
Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with Carticel implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. Carticel cultured chondrocytes are not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling Carticel chondrocytes. In addition, they should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.
The occurrence of a subsequent surgical procedure, primarily arthroscopy, following Carticel implantation is common. The most common reactions (≥5% of patients), derived from the Study of the Treatment of Articular Repair (STAR), include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.
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 9,000 employees in locations spanning the globe. Genzyme has been selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.
With many established products and services helping patients in nearly 90 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, orthopedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
Genzyme®, MACI® and Carticel® are registered trademarks of Genzyme Corporation. All rights reserved.
Zheng et al. Matrix-Induced Autologous Chondrocyte Implantation (MACI): Biological and Histological Assessment; TissueEngineering 2007; 13 (4): 737-746.