In the U.S.—

• Cartilage repair adjunct

Autologous cultured chondrocytes ( aw-TOL-a-gus KUL-tured KON-droe-sites) are used, as part of an overall program that includes knee surgery and special exercises, to help repair damaged knee cartilage. Cartilage is a type of tissue that joins together and helps support parts of the body. Autologous cultured chondrocytes are the patient's own cartilage cells. The cells are removed 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 part of the knee. After implantation, the chondrocytes help form new, healthy cartilage.

In deciding to use a product or procedure, the risks must be weighed against the good it will do. This is a decision you and your doctor will make. For autologous cultured chondrocyte implantation, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to gentamicin (e.g., Garamycin), an antibiotic used to treat certain infections. Also tell your doctor if you are allergic to beef or other products obtained from cows.

Pregnancy—Tell your doctor if you are pregnant or if you think you might be pregnant. It is not likely that the implanted chondrocytes would affect the fetus. However, you should discuss with your doctor whether you should be having this procedure, and having to use crutches for several weeks afterward, while you are pregnant.

Breast-feeding—It is not likely that the transplanted chondrocytes would affect a nursing baby. However, whether you should be having the procedure at this time, when you are busy caring for an infant, should be discussed with your doctor.

Children—Implantation of autologous cultured chondrocytes has been done only in adults, and there is no information about the effects of this procedure in children.

Older adults—Implantation of autologous cultured chondrocytes has not been studied specifically in older people. There is no information comparing use of this procedure in the elderly with use in other age groups.

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

Dosing—

The amount of autologous cultured chondrocytes needed to repair damaged knee cartilage will be different for different patients. It will depend on the size of the damaged area. Most patients will receive between 0.64 million and 3.3 million cells for each square centimeter of damaged area. (A square centimeter covers an area slightly longer than 3/8 of an inch on each side.)

Use crutches to help you walk for the first 6 or 7 weeks after receiving the implant. Walk as normally as possible with the crutches. However, place no more than 25% of your weight on the leg that received the implant. Let the crutches and your other leg hold the rest of your weight. After the first 3 weeks, or when directed by your doctor, you may gradually increase the amount of weight placed on the knee.

Check with your doctor right away if sharp pain occurs in the knee that received the implant, or if “locking” of the knee occurs.

After the implant surgery, your doctor will direct you to start a rehabilitation program that includes exercise. This program is a very important part of your treatment. You will be instructed to start out slowly and to increase gradually the number of times that you do each exercise. To get the most help from this program, it is very important that you follow the instructions as closely as possible. Do not do different exercises, and do not increase the number of times you do each exercise faster than directed. If pain or swelling occurs when you increase the amount of exercise you are doing, go back to the last level of exercise until the pain and swelling are gone, then try again. Use ice packs to help reduce the swelling.

Along with its needed effects, the implant or the surgical procedure during which the cells are implanted may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur soon after the implantation procedure:

• Less common
  • Bruising (severe);  signs of an infection, such as heat, redness, swelling, and/or oozing at the place of surgery 
  
  

• Rare
  • Fever and pain (occurring together) 
  
  

Other side effects may not occur until weeks, months, or even years after the implantation. Check with your doctor if any of the following delayed side effects occur:

• More common
  • “Crackling” sound or pain when moving the knee;  stiffness or “catching” of the knee 
  
  

• Less common or rare
  • Inability to bend the knee;  swelling of the knee 
  
  

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