Apligraf®, skin substitute for chronic venous leg ulcers and diabetic foot ulcers

Dermal patch

Apligraf® consists of living cells and structural proteins. The lower dermal layer combines bovine type 1 collagen and human fibroblasts, which produce additional matrix proteins. The upper epidermal layer is formed by multiplying human keratinocytes, that differentiate to replicate the architecture of the human epidermis. Unlike human skin, Apligraf® does not contain melanocytes, Langerhans cells, macrophages, and lymphocytes or other structures such as blood vessels, hair follicles or sweat glands. Apligraf® is supplied as a circular disc approximately 75 mm in diameter and 0.75 mm thick.

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In chronic wounds, it is proposed that bilayered bioengineered skin substitute (BBSS) may stimulate the healing process by supplying matrix materials, cytokines and other regulatory factors in correct sequence and quantity.

In vitro, BBSS provides a significant barrier to water and responds to irritants in a similar manner as does human skin.

Application of BBSS to full-thickness wounds in athymic mice indicated that it is capable of acting as a frank graft. BBSS persisted in the wound and developed morphological features that closely resembled those of intact skin.