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In recent years, skin grafting has evolved from the initial autograft and allograft preparations to biosynthetic and tissue-engineered human skin equivalents (HSE).Apligraf (graftskin) (Organogenesis, Canton, MA), also referred to human skin equivalent, is a living, cell-based, bilayered skin construct.

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Apligraft has been approved for marketing under a premarket approval for "use with standard therapeutic compression for the treatment of noninfected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy." Multiple supplemental approvals have been added since the first approval, including an indication for treating diabetic foot ulcers.

Several of the supplements involve approval of the use of new human keratinocyte or fibroblast cell strains in the manufacture of Apligraf (Snyder, et al., 2012).

Like human skin, Apligraf has 2 primary layers, including an outer, epidermal layer made of living human keratinocytes, the most common cell type of the human epidermis, to replicate the structure of the human epidermis.

The human keratinocytes and fibrobasts are derived from neonatal forsekins.

Venous ulceration, a relatively common manifestation of venous hypertension, is often refractory to conservative treatment and difficult to treat.

Human skin equivalents appeared to promote wound healing in 3 ways: Rice et al (2015) used Medicare claims data to assess the real-world medical services utilization and associated costs of Medicare patients with diabetic foot ulcers (DFUs) treated with Apligraf or Dermagraft (human fibroblast-derived dermal substitute (HFDS)) compared with those receiving conventional care (CC).

The fibroblasts are cultured on a bioarbsorbable polyglactin mesh.

Proteins and growth factors are secreted during the culture period and generate a three dimensional human dermis.

Specific manufacturing process vary by company, but generally involve seeding selected cells onto a matrix, where they receive proteins and growth factors necessary for them to multiply and develop into the desired tissue.

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