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Carticel®
(autologous cultured chondrocytes), marketed in the United States and
Europe by Genzyme Biosurgery, employs a commercial process to culture a
patient's own (autologous) cartilage cells, known as chondrocytes, for
use in the repair of symptomatic cartilage defects of the femoral
condyle (medial, lateral, or trochlear) caused by acute or repetitive
trauma in patients who have had an inadequate response to a prior
arthroscopic or other surgical repair procedure. It is not indicated as
a treatment for people suffering from osteoarthritis. It is not
recommended for use in patients with a known history of allergy to the
antibiotic gentamicin, in patients with sensitivities to materials of
bovine origin, who have an unstable knee, or who have an abnormal weight
distribution within the joint. Patients who have previously had cancer
in 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. Data regarding outcomes beyond 3 years are
limited. The most frequently reported adverse events are: hypertrophic
tissue at the repair site, intra-articular adhesions, superficial wound
infection, hypertrophic synovitis, and post-operative hematoma. See
accompanying package insert for additional information on warnings,
precautions and adverse events.
Once damaged, joint cartilage does not normally regenerate in the body.
In addition to causing pain and restricted mobility, chronic injuries to
joint cartilage over time may lead to further deterioration of the joint
surface. These manifestations can severely hinder a person's normal
activities and occupation. |
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Some people undergo arthroscopic
surgery to smooth the surface of the damaged cartilage area. Other
surgical procedures, such as microfracture, drilling, and abrasion, may
provide symptomatic relief, but the benefit usually is temporary,
especially if the person's pre-injury activity level is maintained.
These procedures are performed with the intent of allowing bone marrow
cells to infiltrate the defect, resulting in the formation of a fibrous
cartilage tissue, which is less durable and resilient than normal
articular cartilage.
More severe and chronic forms of knee cartilage damage can lead to
greater deterioration of the joint cartilage and may eventually lead to
some of the many total knee joint replacements performed each year.
Approximately 200,000 total knee replacement operations are performed
annually. The artificial joint generally lasts only 10 to 15 years and
is therefore not recommended for people under the age of 50 (consult
your doctor about this option).
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The technique of autologous cultured
chondrocytes implantation was initially researched at the Hospital for
Joint Diseases in New York and further developed at the University of
Gothenburg and Sahlgrėnska University Hospital, Gothenburg, Sweden, in
an effort to provide a treatment option for people with joint cartilage
damage.
Carticel is used in people who are experienceing knee pain as a result
of an inadequate response to a prior arthroscopic or other cartilage
repair procedure. Patients with this type of cartilage damage also
display symptoms that include locking, catching, localized pain and
swelling. |
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The procedure starts when a trained
orthopedic surgeon provides Genzyme Biosurgery with a biopsy of healthy
knee cartilage, about the size of a raisin, from the patient during an
arthroscopic procedure. Technicians at the company's FDA licensed cell
processing facility in Cambridge, Mass., use proprietary methods to grow
millions of new cells for that patient.
The cells are then delivered in a vial to the surgeon who implants them
into the defect in a surgical repair procedure. During surgery, the
physician carefully removes damaged tissue and prepares the defect for
the introduction of the cultured cells. A small piece of the periosteum,
the tissue covering a bone, is taken from the patient's lower leg and
sutured over the defect like a patch to hold the cells in place. The
cultured cells are then implanted under the periosteum in the defect
where they can fill the defect with a durable cartilage. Most patients
are back to full weight bearing within 6-8 weeks and resume physical
activity within one year.
As of March 31, 2000, 3,952 patients had been treated since Genzyme
began marketing the product in 1995. There are 136 million people
covered by insurance plans that pay for Carticel® (autologous cultured
chondrocytes) as a matter of policy in the United States.
Today Carticel® is considered a viable treatment option and
most healthcare plans now reimburse fully for appropriate patients -
check with your health care administrator where you work for more
details or contact us at Genzyme Biosurgery. |
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The Surgery
Carticel® (autologous cultured
chondrocytes) is one of the exciting treatment options that has demonstrated
important benefits to patients with specific types of cartilage defects on the
end of the thigh bone or femur. Carticel provides surgeons with a "biologic
option" to treat patients who have failed to receive or obtain symptomatic pain
relief from a previous surgical repair procedure.
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After ensuring that the injury site is water tight, Carticel is
implanted beneath the periosteum. Here the cells may continue to
multiply, forming the building blocks of healthy cartilage and
integrating with surrounding cartilage. With time, the cells will mature
and fill in the injury site with a firm, durable tissue. |
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Yes. All patients undergoing Carticel® (autologous
cultured chondrocytes) implantation will need to follow a strict
rehabilitation program. Although specific exercises and length of the
rehabilitation period may differ from patient to patient, your surgeon
and physical therapist will recommend a program for you based on the
size, location, and severity of your cartilage injury.
Walking without the assistance of a crutch or
cane can generally begin between 3-5 months. Consult your surgeon or
physical therapist for specific recommendations.
That depends upon the length of your
rehab and the specific sport you are playing. Generally, low-level
activity such as swimming, biking, walking, or skating, may be resumed
as early as 6 months following treatment. More strenuous activity
involving pivoting or twisting, like basketball, soccer, or tennis,
should generally not occur until 12 months post-treatment. Individual
results may vary. Not all patients return to full activity.
If you've been treated with another
procedure, and are still experiencing pain and swelling, you may be a
candidate for Carticel. Questions regarding additional medical treatment
for articular cartilage damage should be directed to your orthopedic
surgeon.
No. Only surgeons specially trained in the
implantation technique may perform the procedure. To locate a surgeon
who can perform the procedure in your area, call Physician and Patient
Services at 1-800-453-6948.
Generally, most insurance plans will cover the
procedure. You should contact your plan administrator for details.
This depends on the size, location, and
severity of your defect. However, your surgeon may allow you to begin to
drive as early as four months following your surgery.
This depends on the complexity and severity of
your cartilage injury and if a concurrent procedure is performed at the
time of implantation. Less complex injuries, you can expect to be
hospitalized for one day; more complex injuries, a multi-day hospital
stay is not uncommon.
Aspirin should be discontinued 7-10 days prior
to surgery. You may consider switching to Acetaminophen. Following
surgery, ice therapy works well. You should consult your surgeon before
taking specific medications before and after surgery.
As with most surgeries, you should refrain
from smoking the day you have your procedure performed.
This is dependent upon the recommendation of
the surgeon; however, usually a shower can be taken following surgery,
but the knee needs to be covered with plastic.
Six to twenty-four hours following surgery;
6-8 hours/day for 2 weeks.
For the first 7-8 weeks, crutches are used
with minimal weight applied to the injured leg. After 2-3 months, you
may switch to a cane. Please consult your surgeon or physical therapist
for specific recommendations regarding the use of crutches or a cane.
Physical therapy usually starts one week
following surgery. Therapy runs approximately 2-3 days per week for 6-8
weeks. During weeks 8-16 gradually increase to full weight
bearing/walking. By week sixteen, home exercises are started. Specific
therapy programs may vary from patient to patient. Please consult with
your surgeon for your specific program.
Yes, at weeks 3-4 when the incision has
healed, however consult with your surgeon for specifics.
Yes, there will be a scar, but with time it
will fade. One scar is over the knee and the other is over the
shin.
Yes, since it is a surgical procedure you may
experience pain, however, the pain is controllable.
Carticel is indicated for the repair of
symptomatic, cartilaginous defects of the femoral condyle (medial,
lateral, trochlear), caused by acute or repetitive trauma, in patients
who have had an inadequate response to a prior arthroscopic or other
surgical repair procedure. The product is not recommended for use in
patients with a known history of allergy to the antibiotic gentamicin,
in patients with sensitivities 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 in 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.
Data regarding outcomes beyond 3 years are limited. In patient data
included in the biologics license application, the following were the
most frequently reported adverse events: "overgrown" tissue at the site
of the cartilage repair, adhesions, superficial wound infection,
inflammation of membranes within the joint, and post-operative bruising.
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