Carticel

INDICATIONS

Carticel (autologous cultured chondrocytes for implantation) 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 (autologous cultured chondrocytes for implantation) 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 (autologous cultured chondrocytes for implantation) is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis.

Carticel (autologous cultured chondrocytes for implantation) is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel (autologous cultured chondrocytes for implantation) implantation.

DOSAGE AND ADMINISTRATION

For Autologous Implantation Only

Dosage

Patients in the Swedish series [see Clinical Studies] received a wide range of cell doses per cm² of defect. Available data on 70 of 78 patients with femoral condyle defects showed a median dose of 1.6 million cells/cm² of defect. The middle 80% of these patients received from 0.64 million to 3.3 million cells/cm².

Each Carticel (autologous cultured chondrocytes for implantation) finished product vial contains approximately 12 million cells. Genzyme provides a single vial for each defect measuring ≤ 7 cm². Two vials of Carticel (autologous cultured chondrocytes for implantation) are provided for defects 7 to 14 cm², and three vials are provided for defects > 14 cm². This is based on Genzyme's greater than 10 years of experience with Carticel (autologous cultured chondrocytes for implantation) .

Handling Precautions and Preparation

Handling Precautions

The Carticel (autologous cultured chondrocytes for implantation) product is intended solely for autologous use. Prior to Carticel (autologous cultured chondrocytes for implantation) implantation, match the patient name and ID number on the certificate of analysis to the patient's chart and the patient ID on the shipping box, transport cylinder and vial.

Healthcare providers should employ universal precautions in handling the biopsy samples and the Carticel product [see Risk of Transmissible Infectious Diseases].

Refer to the INDICATIONS AND USAGE and WARNINGS AND PRECAUTIONS Sections for additional considerations regarding the use of Carticel (autologous cultured chondrocytes for implantation) .

Preparation

NOTE:

The exterior of the Carticel (autologous cultured chondrocytes for implantation) vial containing the cultured cells is NOT sterile. Follow strict sterile technique protocols.

When treating a defect that requires multiple vials of cells, resuspend, aspirate and inject one vial at a time.

  1. Remove red plastic lid from vial. Wipe the vial surface and lid with alcohol.
  2. Inspect vial contents for particulates, discoloration or turbidity. The cellular product appears as a yellowish clump in the bottom of the vial. Do not administer if contents appear turbid prior to cell suspension.
  3. While holding vial in a vertical position, insert the needle of the intraspinal catheter into the vial. The needle must be positioned just above the fluid level. Slowly remove the inner needle from the catheter, leaving flexible tip behind. Attach a tuberculin syringe to catheter.
  4. Lower the catheter tip into the media and position just above the cell pellet. Aspirate all the medium from the vial leaving only the cell pellet behind. Slowly expel medium back into the vial. This action will break the cell pellet and resuspend the cells in the medium.
  5. Lower the catheter tip to the base of the vial and aspirate all contents into syringe, leaving the vial empty. Slowly inject the contents into the vial again. This will assure complete suspension of the cells. Repeat these steps as needed to ensure all cells are resuspended. Cell resuspension is complete when cell particles are no longer apparent, and the medium is a consistent, “cloudy” mixture. Aspirate all contents of vial into syringe. Always hold syringe vertical to keep an air pocket at the proximal end of syringe.
Administration

Implantation of the Carticel (autologous cultured chondrocytes for implantation) product should be restricted to physicians who have completed Genzyme Biosurgery's Surgeon Training Program.

Implantation of the Carticel (autologous cultured chondrocytes for implantation) product is performed during arthrotomy and requires both preparation of the defect bed and a periosteal flap to secure the implant. Complete hemostasis must be achieved prior to periosteal fixation and cell implantation. See the Carticel (autologous cultured chondrocytes for implantation) Surgical Manual, Genzyme document #65021 for instructions on the performance of these procedures.

Implantation

  1. Insert the catheter tip through the superior opening of the periosteal chamber at the site of the defect. Advance catheter to most inferior aspect of the defect.
  2. Slowly inject a cell dose while moving the catheter tip from side to side and withdrawing the catheter proximally. This will ensure an even distribution of the cells throughout the defect.
  3. Complete the implantation by closing the superior opening of the periosteum as instructed. See Carticel (autologous cultured chondrocytes for implantation) Surgical Manual, Genzyme document #65021.

HOW SUPPLIED

Dosage Forms And Strengths

One vial of Carticel (autologous cultured chondrocytes) contains approximately 12 million cells.

The Carticel (autologous cultured chondrocytes for implantation) product, NDC 58468-1025-1, 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.

Storage and Handling

The Carticel (autologous cultured chondrocytes for implantation) 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 (autologous cultured chondrocytes for implantation) Shipping Container or its Contents.

Do Not Sterilize.

If the Vial is Damaged or Sterility has been Compromised, Do Not Use.

Genzyme Biosurgery, A division of Genzyme Corporation, 64 Sidney Street, Cambridge, MA 02139-4136 USA, Telephone: 800-453-6948 or 617-494-8484, Fax: 617-252-0877. Revision L 06/2010

Last reviewed on RxList: 12/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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