Carticel (Implantation)

Autologous cultured chondrocytes are used as part of a complete treatment plan (which includes knee surgery and specific exercises) to help repair damaged knee cartilage from acute or repetitive injuries in patients who have not improved after a previous arthroscopic or other surgical repair. Cartilage is a type of tissue that connects and supports different parts of the body. Autologous cultured chondrocytes are the patient's own cartilage cells. These cells are taken from the patient and sent to a lab, where their number is increased. The cells are then implanted (placed) in the damaged area of the knee. After implantation, the chondrocytes help create new, healthy cartilage.

This medicine should only be given by or under the direct supervision of a trained doctor.

Your doctor will closely monitor your progress while you are taking this medicine. This will help your doctor determine if the medicine is effective and decide whether you should continue using it, as well as check for any side effects.

Use crutches to assist with walking for the first 6 to 8 weeks after receiving the implant.

After the implant surgery, your doctor will instruct you to start a rehabilitation program that includes exercises. This program is a crucial part of your treatment. You will be advised to start slowly and gradually increase the number of times you perform each exercise. To benefit the most from this program, it is very important that you follow the instructions closely. Do not do different exercises, and do not increase the frequency of each exercise faster than instructed. If you experience pain or swelling when you increase your exercise, return to the last level of exercise until the pain and swelling subside, then try again. Use ice packs to help reduce swelling.

Contact your doctor immediately if you feel sharp pain in the knee that received the implant, or if you experience “locking” of the knee.

Autologous cultured chondrocytes are the patient's own cartilage cells. Patients who undergo surgical procedures with Carticel® are not routinely tested for transmissible infectious diseases and may have an increased risk of having them. Discuss this risk with your doctor if you have concerns.

In deciding to use a medicine, it's important to consider the risks against the benefits it may provide. This is a choice you will make together with your doctor. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the effects of Carticel® in children. Safety and effectiveness have not been established.

Geriatric

While there have not been appropriate studies on how age affects the effects of Carticel® in older adults, there are no expected geriatric-specific problems that would limit the usefulness of Carticel® in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if there could be an interaction. If this is the case, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Allergy to gentamicin or aminoglycoside antibiotics or
• Allergy to products made from cows—This medicine should not be used in patients with these allergies.

• Cancer near the injured knee—It is not known if removing and implanting the chondrocyte cells can affect the growth or spread of a nearby cancer.

Along with its needed effects, Carticel (Implantation) may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Sharp pain or "locking" when you try to move your knee joint

Less common

• Bruising (severe)
• difficulty with moving
• heat, redness, swelling, or oozing at the site of surgery
• muscle pain or stiffness
• pain, swelling, or redness in the joints

Less common or rare

• Inability to bend the knee
• swelling of the knee

Rare

• Fever and pain (occurring together)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Carticel (Implantation). Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• “Crackling” sound or pain when moving the knee
• increased growth of scar over your knee joint
• stiffness or “catching” of the knee

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Carticel

This medicine is to be given only by a doctor who have completed Vericel's Surgeon Training Program. Carticel® will be injected into your knee joint with a needle during surgery.