CARTICEL autologous cultured chondrocytes implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

autologous cultured chondrocytes (UNII: D5P3K3V822) (autologous cultured chondrocytes - UNII:D5P3K3V822)

Available from:

Genzyme Corporation

INN (International Name):

autologous cultured chondrocytes

Composition:

autologous cultured chondrocytes 1.2e+007

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CARTICEL- AUTOLOGOUS CULTURED CHONDROCYTES IMPLANT
GENZYME CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARTICEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CARTICEL.
CARTICEL® (AUTOLOGOUS CULTURED CHONDROCYTES)
FOR AUTOLOGOUS IMPLANTATION
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Carticel is an autologous cellular product indicated for the repair of
symptomatic cartilage defects of the femoral condyle
(medial, lateral or trochlea), caused by acute or repetitive trauma,
in patients who have had an inadequate response to a
prior arthroscopic or other surgical repair procedure (e.g.,
debridement, microfracture, drilling/abrasion arthroplasty, or
osteochondral allograft/autograft). (1)
Carticel should be used only in conjunction with debridement,
placement of a periosteal flap and rehabilitation. (1)
Carticel is not indicated for:
treatment of cartilage damage associated with generalized
osteoarthritis. (1)
patients with total meniscectomy unless surgically reconstructed prior
to or concurrent with Carticel implantation. (1)
DOSAGE AND ADMINISTRATION
FOR AUTOLOGOUS IMPLANTATION ONLY
Carticel should be administered only by physicians who have completed
Genzyme Biosurgery’s Surgeon Training
Program. (2.3)
Implantation of the Carticel product is performed during arthrotomy
and requires both preparation of the defect bed
and a periosteal flap to secure the implant.
See the Carticel Surgical Manual, Genzyme document #65021 for
instructions on the performance of these procedures.
(2.3)
DOSAGE FORMS AND STRENGTHS
Each Carticel vial of autologous cultured chondrocytes contains
approximately 12 million cells per vial. (3)
CONTRAINDICATIONS
Do not use in patients with a known history of hypersensitivity to
gentamicin, other aminoglycosides or materials of bovine
origin. (4)
WARNINGS AND PRECAUTIONS
The necessity of subsequent surgical procedures, primarily
arthroscopic, following Carticel implantation is common. In
th