For Autologous Implantation Only
2.1 Dosage
Patients in the Swedish series [see Clinical Studies (14)] 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 finished product vial contains approximately 12 million cells. Genzyme provides a single vial for each defect measuring ≤ 7 cm2. Two vials of Carticel are provided for defects 7 to 14 cm2, and three vials are provided for defects > 14cm2. This is based on Genzyme’s greater than 10 years of experience with Carticel.
2.2 Handling Precautions and Preparation
2.2.1 Handling Precautions
The Carticel product is intended solely for autologous use. Prior to Carticel 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 (5.2)].
Refer to the Indications and Usage (1) and Warnings and Precautions (5) Sections for additional considerations regarding the use of Carticel.
2.2.2 Preparation
NOTE:
The exterior of the Carticel 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.
Remove red plastic lid from vial. Wipe the vial surface and lid with alcohol.
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.
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.
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.
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.
2.3 Administration
Implantation of the Carticelproduct should be restricted to physicians who have completed Genzyme Biosurgery’s Surgeon Training Program.
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. Complete hemostasis must be achieved prior to periosteal fixation and cell implantation. See the Carticel Surgical Manual, Genzyme document #65021 for instructions on the performance of these procedures.
2.3.1 Implantation
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.
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.
Complete the implantation by closing the superior opening of the periosteum as instructed. See Carticel Surgical Manual, Genzyme document #65021.
