Confirming Carticel candidacy and biopsy procurement.

Prior to recommending Carticel, it is vital to assess the patient’s candidacy for treatment. Joint condition, concomitant pathologies, size, and number and extent of defects are critical factors in this consideration. These determinations are primarily conducted through standard arthroscopy.

Always gain commitment from the patient for the Carticel treatment plan prior to the performing of the diagnostic arthroscopy procedure. This way, if you confirm their candidacy during the scope, you’ll know whether or not to take a biopsy for further manufacture into Carticel.

If you have any questions about a patient’s Carticel candidacy, contact your local Carticel Cell Therapy Specialist who is an expert on the matter.

To request a Cartilage Biopsy Transport Kit prior to the diagnostic scope/biopsy procurement procedure, please call Vericel Customer Care at 800-453-6948, Option #1 or fax 866-344-5925.

 

Joint Assessment

  • Carefully inspect articular cartilage, tibial plateau, femoral condyle, patella, and trochlear groove.
  • Assess the patellofemoral joint for abnormal facet tracking and joint surface contact.

Defect Assessment

  • Remove all damaged and unhealthy articular cartilage surrounding the defect as well as loose bodies in the joint.
  • Ensure defect is surrounded by healthy, stable cartilage, measuring at least 2 to 3 mm thick to accommodate for the future suture fixation of a periosteal patch. If the cartilage is not stable, bone anchors should be considered for final implantation.
  • Determine the complete extent and size of the defect to assure that the appropriate number of cell vials is provided at the time of implantation.
    • 1 vial for each defect measuring <7 cm2; 2 vials measuring 7-14 cm2; 3 vials for defects >14 cm2).)

Vericel Cartilage Biopsy Transport Kit

Before harvesting tissue, ensure that the Vericel Cartilage Biopsy Transport Kit is present. Kits can be requested from your Cell Therapy Specialist or by calling Vericel Customer Care at 800-453-6948, Option #1.

  • Inspect the expiration date on the Cartilage Biopsy Transport Container to verify that the biopsy medium has not expired. Biopsy procurement procedure You must obtain two full-thickness biopsies measuring approximately 3 mm x 2 mm (about the size of two Tic Tacs®1). Knee cartilage biopsies must be taken from a lesser weight-bearing, non-articulating surface. The superior medial or lateral femoral articular cartilage margins are recommended as biopsy sites; the intercondylar notch is an alternative site. Biopsy tissue may be procured using either a ring curette or a curved notchplasty gouge.

    View the video below courtesy of Dr. Tom Minas, on taking a cartilage biopsy from the intercondylar notch.

Please note that the FDA mandates that all Carticel orthopedists be certified in order to procure and ship biopsies, i.e., handle human tissue. Your local Carticel Cell Therapy Specialist can provide a brief onsite training and certification to satisfy this requirement. This certification training is also available at larger training courses that Vericel sponsors. The biopsy procedure must be performed in accordance with the procedure outlined in the Carticel Surgical Manual.

Post-biopsy

After obtaining the biopsy, package it in the Cartilage Biopsy Transport Kit and arrange for Vericel to collect it. PLEASE NOTE: The exterior of the Biopsy Transport Container is NOT STERILE.

  • Following sterile technique protocols, carefully place each biopsy sample into the Biopsy Transport Container containing the transport media and seal with cap.
  • Complete all sections of Patient Biopsy Transmittal Notice included in the Cartilage Biopsy Transport Kit. In order for your patient’s biopsy to be processed, please fill out the form completely, including your signature. Also, attach the patient’s Face Sheet.
  • Immediately call Vericel Customer Care at 800-453-6948 (USA) to arrange for biopsy pickup.

1. Tic Tac® is a registered trademark of Ferrero S.p.A.