Product case study Carticel

Carticel is a preparation of autologous cultured chondrocytes used in the treatment of symptomatic cartilage defects of the femoral condyle (the rounded protuberance at the end of the hip bone), caused by acute or repetitive trauma, in patients for whom surgical repair has proven inadequate. It is produced by Genzyme Biosurgery and gained approval for medical use in 1997. Each single-use product container contains approximately 12 million cells devoid of microbial contamination, in a final volume of 0.4 ml sterile, buffered cell culture media (Dulbecco's modified Eagle's medium; Chapter 5).

Chondrocytes are found embedded in the cartilage matrix that they originally produced. Cartilage itself is a dense connective tissue consisting mainly of proteoglycans (biomolecules composed of a protein backbone to which extensive carbohydrate side-chains are attached, such that the molecule is predominantly carbohydrate based). It is capable of withstanding considerable pressure and effectively acts as a shock absorber in joints. There are three types of cartilage: hyaline cartilage is found at bone joints, larynx, trachea, bronchi and nose; elastic cartilage is found in the external ear; and fibrocartilage is found in the intervertebral discs and in tendons.

Chondrocytes are initially harvested from the patient's own body and undergo in vitro expansion via cell culture (Chapter 5) in a medium containing foetal bovine serum. The cells are aseptically filled into vials and are tested for viability and microbial sterility. They are implanted by trained surgeons into the affected area via injection, using a catheter. Typically, between 1 million and 2 million cells are introduced back into the damaged joint area in this way. Both preclinical studies in rabbits, goats, dogs and horses and clinical studies in humans have illustrated the ability of the cultured chondrocytes to promote cartilage repair. However, a significant number of patients treated with Carticel require later surgical intervention, due to locking, clicking or painful joints that is believed to occur due to overgrowth of grafted tissue.

modification or formulation in vitro prior to their medical use. Examples include Carticel (Box 14.6) and Apligraf, a skin substitute used in the treatment of certain ulcers, which is composed of keratinocytes and fibroblasts derived from human neonatal foreskin tissue and bovine collagen.

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