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Learning About Your Knee Condition

Treating Damaged Cartilage

How CARTICEL Can Help

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What To Expect

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Patients > Treating Damaged Cartilage > How CARTICEL Can Help

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How CARTICEL^® Can Help

CARTICEL is a biologic product using your own (autologous) cultured cartilage cells (chondrocytes) to repair the articular cartilage damage in your knee. These cultured autologous cells are grown at Genzyme Biosurgery, and then returned to your doctor and put back into your knee during a procedure called autologous chondrocyte implantation (ACI).

A Two-Stage Process

Receiving CARTICEL is a two-stage process. If your surgeon thinks you may be a candidate for CARTICEL, his or her first step will be to obtain a small amount of your cartilage (a biopsy). Your doctor will perform an arthroscopy on your knee specifically to obtain a biopsy, or he or she may obtain the cartilage biopsy while performing another arthroscopic procedure on your knee.

During the arthroscopy, your doctor inserts a thin tube with a light into the affected knee joint through a small incision in the skin, allowing him or her to see the inside of the joint. He or she then makes another small incision to work in the joint. At this time, your doctor may choose to take a small amount of your existing healthy cartilage, about the size of two pencil erasers, if he or she thinks you are a candidate for CARTICEL.

The biopsy is shipped to Genzyme Biosurgery, where the cells are cultured to increase the number of cells to approximately 12 million cells. Once the cell culturing process is complete, Genzyme Biosurgery returns the cells to your doctor for the second stage of the process, implantation.

Your doctor then implants these autologous (your own) cultured cells in your knee in a second surgical procedure to repair and restore your articular cartilage surface. Over several months, these cells create a matrix to reestablish the articular surface--in effect, replacing the lost cartilage in your knee.

To learn more about preparing for each stage of the process, and about physical therapy following the procedure, please see our What to Expect section.

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).

How CARTICEL® Can Help

How CARTICEL^® Can Help