The aim of this research is to develop technology and devices for the preservation and drying of the dermal portion of human skin so that it may be stored at room temperature for later use in transplantation onto denuded, wounded, or burned areas of patients' body surfaces. Once rehydrated and grafted into place, this preserved dermis will support the engraftment of cultured epidermal cells obtained from normal areas of the patient's skin. The methodology for achieving this goal will be to apply the newly patented LifeCell (register trade mark process for ultrarapid cooling and molecular distillation drying to donated cadaver dermis to produce a room-temperature, dry material. After room temperature storage, this material will be rehydrated in vitro with a variety of solutions experimentally, and cultured keratinocytes will be layered onto it to determine whether support and engraftment of the epidermal cells occurs, with subsequent stratification and differentiation to form an integration of dermis and epidermis. Histological, biochemical, and immunohistochemical (DP, DQ, DR) studies will be undertaken to verify the required structural elements and the preliminary determination of the lack of antigenicity. Later Phase II studies in nude mouse and minipig models and human clinical trials will verify the in vitro determinations.
