About CARTICEL
CARTICEL is a biologic product used to repair articular cartilage injuries in adults who have not responded to an arthroscopic or other surgical repair procedure. It uses your body's own cultured cells to regenerate the articular cartilage in your knee during a surgical procedure called autologous chrondrocyte implantation (ACI). CARTICEL is the name of the cells that are grown from the samples (or biopsy) taken from your knee. When implanted into a cartilage injury, these cells can form new hyaline-like cartilage.
More than 13,000 patients in the United States have had CARTICEL implants since 1995, the year CARTICEL became commercially available. CARTICEL is the first and only biologic product to repair articular cartilage injuries in the knee—and the only FDA-approved autologous cultured chondrocyte product on the market in the United States. It is a product of Genzyme Biosurgery, a company with more than a decade of experience in developing and manufacturing autologous cell therapy products.
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Kevin was living his lifelong dream, playing football for the Naval Academy and training to become a military officer. Then, in one short moment, his life changed.
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Important Safety Information
CARTICEL 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 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 is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. In addition, it 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 subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (≥5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.
For more information on CARTICEL, please see the Package Insert (PDF).