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Medical Professionals > About CARTICEL

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About CARTICEL^®

Genzyme Biosurgery is a pioneer in the emerging field of articular cartilage repair. In 1995, CARTICEL (autologous cultured chondrocytes), the first biologic product in orthopaedics, was made commercially available to surgeons. In 1997, the FDA granted a Biologic License for CARTICEL under accelerated approval regulations. In 2007, the FDA approved new labeling for CARTICEL based on the completion of a post-approval commitment study. This label incorporates safety and efficacy data from the Study of the Treatment of Articular Repair (STAR) as a result of Genzyme’s successful completion of this final confirmatory, post-marketing study.

CARTICEL is manufactured in our state-of-the-art cell processing facility. Genzyme Biosurgery is committed to ensuring that all appropriate quality standards and controls are followed in the manufacture of CARTICEL.

CARTICEL is the only FDA-approved autologous cultured chondrocyte product on the market in the United States.

Benefits of CARTICEL:

Indicated for a range of femoral condyle defects--medial, lateral, and trochlea

For patients who have had an inadequate response to a prior procedure

Creates hyaline-like cartilage in some patients

Integrates with surrounding cartilage and the subchondral bone

Created from a patient’s own tissue (risk of disease transmission is lower with this procedure than with an allograft)

Has demonstrated a decrease in pain and an increase in function in a challenging patient population.¹

References

1. The Study of the Treatment of Articular Repair (STAR) (PDF)

Helpful Resources

Read more about patients' experiences with CARTICEL implantations.

View Case Studies

Contact CARTICEL

For reimbursement questions, contact a Carticel Care® Coordinator at 800-453-6948, Option #2.

For all other questions, contact a Genzyme Biosurgery representative at 800-453-6948, Option #1.

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 (³ 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).

About CARTICEL®

About CARTICEL^®