July 1996 Bulletin

Advisory Statement

Cell- and tissue-engineered products

Cell- and tissue-engineered products are emerging as new treatments of musculoskeletal conditions and diseases. While federal regulation of these products is being developed, they may become available for use by orthopaedic surgeons in patients. Because these products may involve unproven therapies, the American Academy of Orthopaedic Surgeons has developed this advisory statement to provide guidelines for orthopaedic surgeons who use cell- and tissue-engineered products.

Cell- and tissue-engineered products include cells, tissues and/or organic substances that are manufactured, manipulated or altered in a laboratory for implantation into humans. They may include substances that are not naturally found in tissues or whose normal physiologic concentration has been altered. These products may be used alone or in combination with other tissues, drugs, chemicals or devices. Examples of these products include synthetic bone matrices used as bone graft substitutes, bone growth factors used alone or in combination with other products, and autologous cells for regrowth of musculoskeletal tissues.

Cell- and tissue-engineered products must be safe to use in humans. Safety of these products involves not only the assurance that a product will not produce an unwanted side effect in the recipient, but also that a product derived from humans or animals will not transmit disease after implantation. Because federal regulation of cell- and tissue-engineered products is currently being formulated, it is incumbent upon orthopaedic surgeons who use these products to be familiar with any known risks involved with their use and to share this knowledge with their patients.

Knowledge of the effectiveness of therapies involving the use of cell- and tissue-engineered products may be incomplete prior to their availability to orthopaedic surgeons and their patients. Although many of these therapies will no doubt be highly effective and provide a new and advanced method of treating musculoskeletal problems, some new therapies may not be more effective than currently available treatments and some may be less effective. Under these circumstances, orthopaedic surgeons should be familiar with the current knowledge about these products, the proposed indications for their use, and the possible outcomes of procedures which utilize these products. Orthopaedic surgeons should be prepared to discuss with their patients their reasons for choosing a therapy involving these new products and the potential results of their use including the possibility of lack of effectiveness of the new product as a treatment of their patient's condition or disease.

Because the safety and efficacy of treatments involving cell- and tissue-engineered products may not be fully known before they are available to orthopaedic surgeons, the American Academy of Orthopaedic Surgeons advises orthopaedic surgeons to exercise caution with their patients in the use of cell- and tissue-engineered products and similar emerging technologies. The Academy also advises that sound experimental evidence of safety and efficacy combined with clinical studies of these new technologies be developed prior to their general use. Indications and applications of these products must ultimately be determined through well-controlled outcome studies and analyses of their cost-effectiveness. Orthopaedic surgeons should avoid promoting technologies unless their scientific or clinical efficacy has been demonstrated.

May 1996

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