Chondrocytes, autologous cultured (implantation route)

Autologous cultured chondrocytes are just one of the elements used alongside surgery and special exercises to promote repair in knee cartilage that has been damaged.

Overview

Autologous cultured chondrocytes are used in surgical treatment to aid the repair of knee cartilage that has been damaged by sport or other activities. In conjunction with knee surgery and exercises set by a physical therapist, autologous cultured chondrocytes can assist in cartilage repair.

Cartilage is one type of body tissue that is used to connect and support different parts of the body. It is particularly common in joints. Autologous cultured chondrocytes are produced from the cells of the cartilage in the patient who is being treated. These cells are removed and sent to a laboratory for culturing. The cells propagate and are then implanted back into the knee of the patient, where they help to form new healthy cartilage in the knee.

The patient will need to spend 6-7 weeks on crutches following treatment and will need to follow a strict exercise plan in order to recover fully from the surgery.

Condition(s) treated

• Cartilage damage to the knee

Type of medicine

• Cultured cells

Side effects

Along with the desired effects of this treatment, unwanted side effects may also occur. As the cells inserted are from the patient’s own body, the body will not react to them, but their implantation into the knee can have wide ranging side effects. Some of these side effects will need medical attention, whereas others will abate over time.

After surgery you may experience symptoms of infection. If you do experience the following symptoms, you should contact your doctor immediately:

• Heat from knee
• Redness around the area of surgery
• Significant swelling
• Oozing from the place of surgery

You should consult with your doctor if any of the following side effects occur:

• Severe bruising
• Fever and pain occurring at the same time

The following side effects may occur, but they should not normally necessitate you seeking medical attention. These side effects will usually abate over time, but if they become bothersome you can inform your doctor and seek advice:

• Crackling or grinding sound when moving the joint
• Stiffness of the knee during movement
• Inability to bend the knee
• Swelling of the knee

Other side effects that have not been listed herein may also occur. If you experience any other side effects following treatment, then you should contact your doctor for advice.

Dosage

This medication is not administered in a dose. The amount of autologous cultured chondrocytes implanted into the knee will depend on the extent of the damage being treated. In some cases, all of the cartilage will be replaced, but, in others, a smaller proportion will be replaced with the cultured cartilage. Your surgeon will determine the quantity of the cartilage that is replaced.

Each vial of autologous cultured chondrocytes contains approximately 12 million cells.

Interactions

While this medication will not directly interact with other medications that you might be taking, any other medications that you are taking can interact with other elements of the surgery that you will receive in the administration of this treatment. You should inform your doctor of all medications that you are taking, whether they are over the counter treatments, herbal remedies, prescription medications or other substances.

This is particularly important where the medications you are taking affect the blood, heart, liver or kidneys. Other medical problems from which you suffer can also impact the use of this treatment. You should inform your doctor of all medical conditions from which you suffer, particularly if they relate to the blood, liver, kidney or heart.

It is unknown whether this surgery could affect the growth or spread of cancer located near the knee. If you have cancer, then you should discuss this with your doctor before proceeding.

Warnings

In deciding whether to undergo this treatment, you should consider the risks of doing so in relation to the benefits. You should make this decision with your doctor and should ensure that you have considered all of the following:

Alternative treatments

Surgery should only be considered once other avenues have been explored. Consider physical therapy and exercises as a primary route before opting for surgery.

Allergies

You should inform your doctor of any and all allergies that you have suffered from in the past or do suffer from currently. This is particularly important if you have ever suffered from an allergic reaction to any medications.

Pediatric

This procedure has only been performed in adults and there is no information about its use in children. Children should explore other avenues for recovery wherever it is possible to do so.

Geriatric

This treatment has not be studied with particular focus on the elderly and there is no available information about the effect it has on this group in comparison to other age groups. Elderly patients will, however, often be more susceptible to infection, which can make them less suitable to undergo this treatment.

Pregnancy

Whilst this treatment itself does not pose a risk to a fetus in a pregnant woman, it does require the administration of a general anesthetic to the mother. This has been demonstrated to pose a risk to the fetus and should be avoided where possible. The pregnant woman would be advised to wait until after she has given birth before undergoing treatment. You should discuss this with your doctor if you believe yourself to be pregnant.

Breastfeeding

There are no adequate studies to determine the risk of this treatment in relation to breastfeeding infants. You should discuss this with your doctor if you are breastfeeding.

Following treatment, the patient will need to use crutches to walk for 6-7 weeks. The patient should walk as normally as possible, without placing any more than 25% of the body weight on the knee that received the implant. It is important, however, that usual motion is carried out with the knee, so that the complete range of motion will return to the patient.

Three weeks after the implant, the patient may be able to increase loading on the knee, as directed by the physical therapist or doctor.

You should contact your doctor immediately if you experience a ‘locking’ of the knee or a sudden sharp pain in the knee.

After surgery you will need to start a rehabilitation program. This is a very important part of the treatment and how well you follow this will ultimately determine how well you recover from the surgery and how much movement you will regain in the future. This rehabilitation will include exercises that you should complete closely. Do not do other knee exercises that have not been ordered and do not do the exercises more quickly or a greater number of times than ordered.

If swelling and pain occur when you increase the number of exercises, you should decrease them back to an earlier level until the swelling and pain subsides. Ice packs placed on the knee will help to reduce swelling.

Storage

The Carticel transport box should be maintained at controlled room temperature and should remain sealed until the implantation surgery is due to take place. This will ensure the cells are held in the proper condition.

Do not store the container or the contents of the container in a refrigerator, incubator or freezer.

This treatment should not be sterilized before use.

Do not use this treatment if the vial is damaged or there is a suspicion that sterility has been compromised.

Summary

Autologous cultured chondrocytes are cultured cartilage cells that have been taken from the patient's own cartilage. These cells are sent to a laboratory for culturing, before being returned in vials containing approximately 12 million cells each. These cultured cells are used to replace the removed, damaged cartilage of the patient and will help to promote healthy redevelopment of the cartilage in the knee.

This treatment is part of a wider process of treatment that requires surgery and physical therapy. While the direct side effects of this treatment are minimal, there are wider ranging potential side effects that can occur from the entire treatment that should be discussed with your doctor. The biggest direct risk from this treatment is the risk of infection, which patients should be aware of and closely monitor following the treatment and in the immediate weeks afterwards.

This treatment should not be a first resort and patients should attempt to fix their knee damage through exercises and physical therapy before undergoing surgery.

Once surgery has been carried out, the patient will need to use crutches for 6-7 weeks and will need to follow a strict regimen of exercises. How well the patient follows these exercises and movements will directly impact the patient's quality of the recovery and the range of movement that they regain. It is very important that the usual range of movement is maintained through the recovery period or it is possible that full movement will never be recovered following treatment.