Bioengineered skin and treatment of wounds: Use of an epidermal-dermal construct (Apligraf®)

Major technological advances over the past two decades have led to the development of bioengineered skin composed of both epidermal and dermal components, for use in the treatment and healing of chronic wounds. The most advanced bioengineered skin construct, Apligraf®, has been approved in the U.S. and Canada for treating venous ulcers. Neonatal foreskin serves as the source of the cellular components, with careful screening and stringent quality control procedures being employed throughout the manufacturing process to ensure the complete absence of any potential pathogens or contaminants. A prospective randomized trial compared Apligraf® with standard compression therapy in 240 patients with venous ulcers. Apligraf® proved to be significantly (p<0.005) superior to the control treatment in the ability to completely heal ulcers within 6 months, and was 60% more effective in achieving wound closure. This bioengineered skin product has been observed to cause the ulcer to heal from the edge of the wound bed, suggesting its ability to stimulate host tissue to heal by supplying growth factors in the appropriate sequence and concentration. Recent extensive clinical experience has shown that one Apligraf® application is usually sufficient to achieve a successful graft or stimulate wound healing. Apligraf® also shows considerable promise in a wide range of other wound-healing applications, providing a safe, rapid and consistently high level of wound stimulation previously unattainable with other types of therapy.