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Tissue Engineering Products: Carticel® (Genzyme)

 

Carticel is a product of Genzyme developed in the early nineties and FDA approved in 1997. Carticel became the first cell-based technology to be industry regulated by the FDA for medical therapies. Carticel® autologous chondrocyte implantation treatment is as follows:

  1. Biopsy of healthy cartilage.
  2. Shipping of biopsy to Genzyme Tissue Repair for chondrocyte replication in cell culture.
  3. Cultured cells sent to the surgeon in DMEM suspension.
  4. Debridement of the defect area with a ring curette or gauge.
  5. Periosteal Patch harvested from proximal tibia sutured into place over debrided region.
  6. Carticel® implanted under the patch.

Carticel®, over the last 9 years (clinical trials started in 1995), has treated around 10,000 patients with knee damage (16). The usage of this technology in 2000 to treat shoulder injuries opens a new market for Genzyme and a new therapy to help competitive athletes return to their sports. The main difference between Carticel® and other ACI treatments is the usage of the periosteal patch first described by Rubek et al (17) in 1982 to hold the cultured chondrocytes in place after implantation. The benefits of this method include the usage of autogenic transplant patch and strong clinical support for periosteal efficacy (18). However, Carticel® treatment requires not one but 2 surgeries and bone harvesting sites. A periosteal response can result in possible hypertrophic osteoarthropathy due to unknown signals; steroids, increased blood supply, and nerve interruption have been implicated (19). Also, the usage of autogenic transplant of the periosteal patch and of the autologous chondrocytes restricts the application of this technology to patients between the ages of 15 and 50 years. Patients with osteoarthritis do not qualify for Carticel® treatment.

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Created by: Blair Smith, Connie Lee, Daniel Solomon, Matthew Whitson and Stephanie Chang
Date last modified: 5/2/2004