Chondrocytes, autologous cultured (Implantation)

Autologous cultured chondrocytes are used as part of a complete treatment plan (that includes knee surgery and specific exercises) to help repair damaged knee cartilage from sudden or repeated 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. The cells are taken from the patient and sent to a laboratory, where they are processed to increase their number. The cells are then implanted (placed) in the damaged area of the knee. After implantation, the chondrocytes assist in forming new, healthy cartilage.

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

Your doctor will monitor your progress closely while you are taking this medicine. This will help your doctor see if the medicine is working correctly and decide if you should continue taking it, as well as check for any unwanted 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 guide you to begin a rehabilitation program that includes exercise. This program is a crucial part of your treatment. You will be told to start slowly and gradually increase the number of times you do each exercise. To benefit the most from this program, it is very important to follow the instructions closely. Do not do different exercises, and do not increase the number of times you do each exercise faster than instructed. If you experience pain or swelling when increasing your exercise, return to the last level of exercise until the pain and swelling decrease, then try again. Use ice packs to help reduce swelling.

Contact your doctor immediately if sharp pain occurs in the knee that received the implant, or if the knee feels like it is “locking.”

Autologous cultured chondrocytes are the patient's own cartilage cells. Patients undergoing surgical procedures using Carticel® are not routinely tested for transmissible infectious diseases and may face 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 of taking the medicine compared to the benefits it may provide. This is a decision you will make with your doctor. For this medicine, the following should be kept in mind:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

There have not been appropriate studies on the effects of Carticel® in children. Safety and effectiveness have not been proven.

Geriatric

While there have not been appropriate studies on the effects of Carticel® in older adults, it is not expected that age-related problems will limit its usefulness in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. You should weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor might want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you 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

• Severe bruising
• Difficulty with moving
• Heat, redness, swelling, or oozing at the surgery site
• 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 the medicine. Your health care professional may also be able to offer ways to prevent or lessen 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.