Epiflex® A new decellularised human skin tissue transplant: manufacture and properties

• Published in: Cell and tissue banking Vol. 12; no. 3; pp. 209 - 217
• Main Authors: Rössner, E., Smith, M. D., Petschke, B., Schmidt, K., Vitacolonna, M., Syring, C., von Versen, R., Hohenberger, P.
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.08.2011; Springer
• Subjects: Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Bone marrow, stem cells transplantation. Graft versus host reaction; Cell Biology; Dermis - metabolism; Dermis - transplantation; Dermis - ultrastructure; Humans; Humidity; Life Sciences; Medical sciences; Original Paper; Permeability; Skin Transplantation - trends; Sterilization; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Transplant Surgery; Water - metabolism; Acellular dermis; Wound healing; Tissue processing; Transplant; Human; Graft(material); Tissue bank; Transplantation; Homotransplantation; Properties; Wound; Tissue; Treatment; Acellular derm; Surgery; Graft; Skin; Cell; Cicatrization
• ISSN: 1389-9333; 1573-6814
• DOI: 10.1007/s10561-010-9187-3

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.