how does carticel work?
Carticel is a biologic product used to repair articular cartilage damage. The procedure is called Autologous Chondrocyte Implantation (ACI). First, an orthopedic surgeon takes a small biopsy of your healthy articular cartilage, usually the size of two pencil erasers, and sends it to Genzyme Biosurgery. 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 transfer vial and shipped back to your surgeon. It arrives by special courier the morning of surgery.
The second step is the surgery itself. Your surgeon will make an incision in your knee, and prepare your injury site by cleaning away all the damaged tissue. The surgeon will then cover the lesion with a patch taken from tissue covering your shinbone (tibia). The surgeon injects your newly grown cartilage cells (Carticel) under the patch into the lesion. The cells attach to the bone, multiply and mature to form a cartilage repair.
Third, you will need to go through the personalized rehabilitation program recommended by your surgeon.
is carticel an artificial material and can it be rejected?
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 congeals 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 maturation process. Though very rare, programs too aggressive can lead to graft failure. 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.
am i a candidate for 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 orthopedic 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 call Genzyme Biosurgery at 1-800-453-6948 or visit www.carticel.com.
In the Texas, New Mexico, Oklahoma, Arkansas, and Louisiana areas, you may elect to call The Joint Preservation Center located in Arlington, Texas. Physicians associated with The Arlington Orthopedic Associates have extensive experience in ACI. They can help with your questions and evaluate whether ACI is a good option for your problem. They can be reached at phone 817-784-7062; fax 817-299-1756 or at our web site at www.jointpreservationcenter.com.
if i have an injury to my joint surface do i have to have carticel?
No. Carticel was created for injuries that are not applicable to other treatment options. Many injuries are too large for other options. Lesions greater than approximately 1.5 X 1.5 cm 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 options.
what happens if i do not have any further surgery on my knee for my injury?
This of course depends on the injury. But, if we presume that your knee is stable and you have an isolated injury to your joint surface, then you can anticipate several things. If the lesion is very small, less the one centimeter in diameter, you may go for several years without any symptoms. If, however, your injury is larger or in one of the more important weight bearing areas, then, without appropriate treatment, you will have a greater than normal chance of arthritis. In that case, you can anticipate pain, swelling, occasional locking and giving way. These symptoms may well progress in severity with time.
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 with one year (12 Months). Although in rare circumstances, patients can wait for their surgery, if your symptoms continue, you should consider having your implantation as soon as is convenient to your schedule to prevent possible further injury or progression of your current injury.
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 trials in Europe. It is currently FDA approved. There are new studies being done examining the results of over 17 years of experience. As of September 2001, over 6000 patients had been treated with Carticel.
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.
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.
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.
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. Surgeons at the Joint Preservation Center (JPC) have been specifically trained in the complicated procedure of ACI. The JPC in conjunction with Arlington Orthopedic Associates has done extensive lecturing on the topic and has hosted several seminars to teach the techniques to physicians from around the United States.
is this an outpatient procedure?
This is determined on a patient per patient basis. Most 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.
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 orthopedic 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.
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, malalignments, presence of the meniscus, and patellar elevation decompression procedures.
what else do i need to know about carticel?
The product is not recommended for use in patients with a known history of allergy to the antibiotic Gentamicin, in patients with sensitivity to materials of bovine origin, who have an unstable knee, or who have abnormal weight distribution within the joint. 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.