Abstract
The manufacture and initial testing of a new human tissue transplant is described. Epiflex(®) is a human acellular dermis transplant that is manufactured from skin recovered from screened consenting donors according to validated and approved methods. The transplant is approved as a drug in Germany. The safety, stability and usability of the transplant are discussed with respect to the results of sterility, residual moisture content and rehydration tests. Histological and confocal laser scanning microscopy experiments and analysis of oxygen and water vapour permeability demonstrate that the native extracellular matrix structure and transport properties of human connective tissue are retained in the transplant. Results from initial clinical investigations suggest that Epiflex(®) can be used successfully in the treatment of burns, hypertrophic scars and as a transplant seeded with autologous dermal fibroblasts for soft-tissue regeneration in settings with wound healing problems following multi-modal treatments for sarcomas of the extremities.
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