Carticel: Frequently Asked Questions
HOW DOES CARTICEL WORK?
Carticel is a biologic cartilage product used to repair articular cartilage damage (grown from YOUR CARTILAGE). The procedure is called Autologous Chondrocyte Implantation (ACI). First, an orthopaedic surgeon takes a small biopsy of your healthy articular cartilage, about the size of two pencil erasers, and sends it to Genzyme Biosurgery company. This is a unique laboratory and the only one of its kind in the United States. Genzyme then grows the cells until there are enough to repair your defect (this takes about 5 weeks). The cells are put into a special vial and shipped back to your surgeon. It arrives by courier the morning of surgery.
The second step is the surgery itself. Your surgeon will make a knee incision (smaller than joint replacement surgery), and prepare your injury site by cleaning away all the damaged tissue. The surgeon will then cover the lesion with a natural or specially processed biologic membrane. This is sewn on with many many tiny sutures. The surgeon injects your newly grown cartilage cells (Carticel) under the membrane into the lesion. The cells attach to the bone, multiply and mature to form a new cartilage repair.
Third, you will need to go through the personalized rehabilitation program recommended by your surgeon.
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COULD I HAVE CARTICEL EVEN IF I'VE UNDERGONE OTHER TREATMENTS FOR KNEE PAIN?
If you’ve undergone other treatments to address your cartilage injury but are still experiencing pain and swelling, you may be a candidate for Carticel. Consult with an orthopaedic surgeon specifically trained in Autologous Chondrocyte Implantation (ACI) to find out if Carticel is the right treatment for you. To locate a qualified surgeon in your area, visit www.carticel.com.
In the Baltimore-Washington, Virginia, Southern Pennsylvania area, you may consider contacting Chesapeake Orthopaedic & Sportsmedicine Center. We can help with your questions and evaluate whether ACI is a good option for your problem. We can be reached at phone 410-768-5555 or at our web site at www.chesortho.com and www.orthopedicDoc.net .
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IS CARTICEL AN ARTIFICIAL MATERIAL, OR CAN YOUR BODY REJECT IT?
No. Carticel is a biologic material. It is a growth of cells from your own body and therefore it cannot be rejected. It is implanted as a suspension of cells, then settles like gelatin, and then with time slowly hardens. If the rehabilitation process is not done correctly or done too aggressively, it can damage or retard the cell growth and maturation process. Because the graft is biologic, it must heal and mature like other tissues. A consistent conservative program prescribed by your surgeon may yield more successful results.
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IF I HAVE AN INJURY TO MY JOINT SURFACE, WILL CARTICEL HELP ME?
Many injuries are too large for other simpler cartilage options. Lesions greater than approximately 5/8 inch by 5/8 inch are too large for many other treatments currently available and may best be treated by Carticel. Further, there are certain areas of the knee such as the notch (trochlea) or the kneecap (patella) of the knee where the contours may prohibit other surgical treatments.
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IF I HAVE A CARTILAGE DEFECT (HOLE), CAN I GET AWAY WITHOUT SURGERY?
This depends on the injury. If your knee is stable and you have a single injury on your joint surface, then you can anticipate several things:
If the damage is very small, less the 3/8 inch in diameter, you may go for several years without any symptoms. If your injury is larger or in one of the key weight bearing areas, then, without appropriate treatment, you will have a greater chance of arthritis occurring. With arthritis, you can anticipate pain, swelling, some locking and giving way. These symptoms might progress in severity with time.
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HOW LONG AFTER THE BIOPSY DO I HAVE TO DECIDE IF I WANT THE ACI PROCEDURE?
Once the biopsy is taken it is sent to a special laboratory in Boston, Massachusetts. It is processed and then frozen. It can then be stored. For safety reasons, most decisions for implant need to be made within 1 to 1 ½ years. Although in rare circumstances, patients can wait for their surgery, if your pain continues, you should consider having your cartilage implantation as soon as is convenient to your schedule to prevent possible further injury or worsening of your current situation.
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HOW LONG HAS CARTICEL BEEN IN USE?
Carticel was first commercially available in 1995 in the United States. Prior to that it had undergone extensive evaluations and use in Europe. It is currently FDA approved. There are new studies being done examining the results of many years of experience. There have been approximately 10,000 Carticel surgeries.
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HOW LONG DOES IT TAKE TO GROW THE CELLS?
The surgeon takes a biopsy of your healthy cartilage and sends it to Genzyme Biosurgery. Once Genzyme begins to grow the cells, it takes 4-5 weeks to accumulate enough cells. The biopsy usually contains approximately 150,000 - 200,000 cells. These are then grown to a volume of 10,000,000 for the second stage implantation.
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HOW SOON AFTER THE BIOPSY CAN THE IMPLANT TAKE PLACE?
Once the biopsy is taken, it only takes 4-5 weeks to grow the cells. However, most surgeons will ask you to get over your first arthroscopic surgery before proceeding with the implant. This can take about 4-6 weeks anyway.
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WILL MY INSURANCE PAY FOR CARTICEL?
Most insurance plans cover the cost of Carticel. Check with your particular plan administrator or contact a Genzyme Biosurgery specialist who will work with you to get approval for your surgery. Call 1-800-453-6948.
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CAN ANY SURGEON TREAT ME WITH CARTICEL?
No. Only surgeons specifically trained in the implantation technique may perform the procedure. To locate a surgeon who can perform the procedure in your area, call Customer Care at 1-800-453-6948 or visit the Genzyme web site at www.carticel.com. Knee specialists at Chesapeake Orthopaedic & Sports Medicine have been specifically trained in the complicated procedure of ACI.
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IS CARTICEL SAFE?
As with any surgery done with anesthesia, complications can occur. Autologous Chondrocyte Implantation has no more but no less complications than any other orthopaedic surgical procedure. In patient data included in the biologic license application, the following were reported as possible adverse events: “overgrown” tissue at the site of the cartilage repair, adhesions, wound infection, inflammation of the tissues in or around the joint, and postoperative bruising.
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WHAT IS THE SUCCESS RATE OF THE PROCEDURE?
Carticel has been shown to be about 90% successful with single lesions. With multiple lesions and patellar lesions success ranges from 80% to 90%. Success is significantly influenced with correction of instabilities, malalignment, presence of the meniscus, and patellar (kneecap) elevation decompression procedures.
WHAT ELSE DO I NEED TO KNOW ABOUT CARTICEL?
Patients who have previously had cancer of the bones, cartilage, fat or muscle of the treated limb should also not be treated with Carticel. Any instability of the knee or malalignment of the joint should be corrected before or concurrent with Carticel implantation. Use in children, or in joints other than the knee has not yet been assessed. Carticel is not used for the treatment of generalized arthritis of the knee.
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IS THIS AN OUTPATIENT PROCEDURE?
This is determined on a patient per patient basis. Many procedures are done as an outpatient. The anesthesia, nerve blocks and local injection anesthetics all are designed to keep you relatively comfortable so that you may leave the same day of surgery. Your physician can address your particular procedure.