autologous keratinocytes + fibroblasts

Autologous keratinocytes + fibroblasts is a bilayered, tissue-engineered cell therapy designed for permanent skin replacement in patients with extensive skin loss, such as catastrophic burns or chronic refractory ulcers. This therapy involves harvesting a small, full-thickness biopsy of the patient's own skin, from which keratinocytes (epidermal cells) and dermal fibroblasts are isolated, expanded extensively in vitro, and seeded onto a biodegradable three-dimensional scaffold, typically a bovine collagen-glycosaminoglycan matrix. The construct facilitates the reconstruction of both the dermal and epidermal layers of the skin: the fibroblasts synthesize extracellular matrix components and secrete growth factors that promote tissue maturation and angiogenesis, while the keratinocytes proliferate and differentiate to form a stratified, protective epidermis. Unlike allogeneic substitutes or single-layer grafts, this bilayered autologous approach provides a permanent solution that minimizes donor site harvesting and eliminates the risk of immune rejection. Leading products like NovaDerm (formerly PermaDerm) have received FDA Orphan Drug designation and are regulated as biological drugs.

Brand names

NovaDermPermaDermBioSeed-SMyOwnSkin

Other names

Cultured Skin SubstituteEngineered Skin SubstituteCSSESSCultured Dermal-Epidermal AutograftCDEAAutologous bilayered skin substitute