Skin replacement products and markets - Biomaterials for Treating Skin Loss - page 13

Table 2.2 Bioengineered skin substitute products

Skin Manufacturer Origin Structure

substitute

Apligraf Organogenesis Human fibroblasts, bilayer

keratinocytes

OrCel OrCel International Human fibroblasts, bilayer

keratinocytes

Dermagraft Advanced Tissue Human fibroblasts dermal

Sciences

TransCyte Advanced Tissue Human fibroblasts, dermal

Sciences silicone sheet

Integra Integra LifeSciences Bovine collagen, chondroitin dermal

Alloderm Lifecell Human dermal matrix dermal

Biobrane UDL Laboratories Porcine collagen, nylon dermal

Oasis Healthpoint Porcine small intestinal dermal

submucosa

Epicell Genzyme Biosurgery Autologous keratinocytes epidermal

designed to replace the dermal component, the epidermal component or both, and
those with a cellular or acellular dermal matrix (Table 2.2).
Apligraf (Organogenesis, Canton, MA, and Novartis, East Hanover, NJ) is a
double-layered bioengineered skin substitute derived from neonatal foreskin
fibroblasts and keratinocytes. The dermal component is constructed using the
cultured fibroblasts combined with bovine type I collagen. Cultured keratinocytes
are then added and allowed, over a period of days, to epithelialize. Apligraf has
been FDA-approved for the treatment of diabetic foot ulcers and venous ulcers . It
costs US$51/cm 2 and has a 10-day shelf life. It is designed to be applied weekly.
While Organogenesis sells other products, Apligraf is its largest revenue generator
and is responsible for most of the company's US$55 million 2007 revenue.
Organogenesis is currently in late-stage development with its next-generation skin
replacement product, called VCTO1, which, like Apligraf, is an allogeneic,
bilayered skin substitute.
Dermagraft (Advanced Tissue Sciences, La Jolla, CA) is a cryopreserved,
human fibroblast-derived, dermal substitute. It is a product similar to Apligraf in
that its dermal component is derived from neonatal fibroblasts. In constrast to
Apligraf, however, Dermagraft does not contain either an epidermal component or
bovine collagen. The extracellular matrix is produced by the fibroblasts which are
grown in a biosynthetic, polyglycolic acid mesh. Dermagraft is FDA-approved for
the treatment of neuropathic and diabetic foot ulcers and wounds secondary to
epidermolysis bullosa. It costs US$34/cm 2 and has a six-month shelf life. Dermagraft
and TransCyte were sold by Smith + Nephew to Advanced BioHealing, in 2006.
TransCyte (Advanced BioHealing) is a product similar, in nature, to Dermagraft.