CARTICEL- autologous cultured chondrocytes implant

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Vericel Corporation

INN (Isem Internazzjonali):

autologous cultured chondrocytes

Kompożizzjoni:

autologous cultured chondrocytes 1.2e+007

Rotta amministrattiva:

INTRA-ARTICULAR

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Carticel® is 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). Carticel should be used only in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. Carticel is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. Carticel is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel implantation. Carticel should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.

Sommarju tal-prodott:

The Carticel product, NDC 69866-1025-1, consists of viable, autologous cells packaged and labeled for implantation within specified time limits. Each vial contains approximately 12 million autologous cells for a single implantation procedure. The shipping vials containing chondrocytes are accompanied by a technical data sheet with detailed specifications for the processed cells. The vial(s) of cells is placed within secondary packaging capable of maintaining the appropriate storage temperature and cell viability for up to 72 hours. The Carticel® transport box should be held at room temperature and remain closed until the time of implantation to ensure proper storage conditions for the cells. Do Not Refrigerate, Freeze, or Incubate the Carticel Shipping Container or its Contents. Do Not Sterilize. If the Vial is Damaged or Sterility has been Compromised, Do Not Use.

L-istatus ta 'awtorizzazzjoni:

Biologic Licensing Application

Karatteristiċi tal-prodott

CARTICEL- AUTOLOGOUS CULTURED CHONDROCYTES IMPLANT
VERICEL 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
Vericel'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, Vericel 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
the STAR study, 4