DEFINITION

Construct Human Keratinocytes and Fibroblasts in Bovine Collagen Scaffold is a living, bilayered skin substitute derived from neonatal foreskins manufactured under Class 100 sterile conditions. The upper, epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum. The inner, dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. Construct Human Keratinocytes and Fibroblasts in Bovine Collagen Scaffold does not contain Langerhans cells, melanocytes, macrophages, lymphocytes, blood vessels, hair follicles, or any other epidermally derived components. The fibroblast and keratinocyte cell banks from which Construct Human Keratinocytes and Fibroblasts in Bovine Collagen Scaffold is derived test negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, mycoplasma, and tumorigenicity. The cell banks are also tested for normal human karyology and isoenzymes. The final product is tested for morphology, cell viability, and physical container integrity. Used tissue culture media are tested for mycoplasma and sterility. All materials derived from bovine sources originate from countries free of bovine spongiform encephalopathy.