Treatment with CARTICEL

CARTICEL uses your own cartilage cells (chondrocytes) to repair the articular cartilage damage in your knee. When implanted into a cartilage injury, your own cells can form new cartilage; this new cartilage is very similar to your original cartilage. The CARTICEL implantation procedure is called Autologous Chondrocyte Implantation or ACI. It is a two-step process.

Step 1: Biopsy

Illustration of biopsy harvest site on knee bone, and biopsy transportation tube

Knee Cartilage Arthroscopy and Biopsy

In the first step, during an arthroscopic procedure, your surgeon assesses the extent of your cartilage damage. If your surgeon believes you are a candidate for CARTICEL implantation, he may take a sample or “biopsy” of healthy tissue about the size of two Tic-Tacs®. This sample is sent to Genzyme Biosurgery.

CARTICEL Manufacturing and Delivery

Your biopsy can be stored for up to two years, so you can schedule your surgery at your convenience. When you are ready, your cells are cultured at our state-of-the-art cell processing facility; over three to five weeks they increase to approximately 12 million cells. Every step of the manufacturing process is monitored to ensure high quality and safety. A courier delivers your cultured cells (CARTICEL) hours before your surgery.

Step 2: Implantation

Knee cartilage defect appearing trimmed and prepared

Cartilage Injury Cleaned

During the second stage of CARTICEL implantation, your surgeon makes an incision to expose your knee and removes any dead or damaged tissue from the injury, leaving only healthy tissue.

Image one depicts periosteal patch on bone surface. Image two depicts second incision location in relation to full leg.

Periosteal Patch

Your surgeon takes a small piece of tissue from your shin bone and sews it securely over the injury.

Cultured chondrocytes being injected beneath sutrured periosteal patchLesion is covered with periosteal patch and sutured

CARTICEL Implantation

Your surgeon injects CARTICEL under the patch.

When CARTICEL is surgically implanted into a cartilage injury, it can grow and form new hyaline-like cartilage, with properties similar to those of the original cartilage. Repairing the injury helps to reduce pain and improve movement and function.

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How CARTICEL works

This animated guide explains the CARTICEL procedure.

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).