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Bormann N.,Charite - Medical University of Berlin | Schwabe P.,Charite - Medical University of Berlin | Smith M.D.,German Institute for Cell and Tissue Replacement | Wildemann B.,Charite - Medical University of Berlin
Bone | Year: 2014

Local infections arising from fracture fixation, defect reconstruction or joint replacement can cause extreme pain and impaired healing, lead to revision operations, prolong hospital stay and increase costs. Treatment options including prophylaxis are afforded by the use of grafts and biomaterials loaded with antibiotics. These can produce local therapeutic concentrations with a reduced systemic concentration and reduced systemic side-effects. Patient-specific loading of osteogenic graft materials with antibiotic could be an important option for orthopaedic surgeons. A local therapeutic concentration must be available for the desired duration and cytotoxic effects must be kept within an acceptable range. The present study investigates a simple and reliable mixing procedure that could be used for the perioperative combination of antibiotic powders and solutions with bone grafting materials. The potential influence of concentration and sampling regime on the release kinetics of gentamicin, tobramycin and vancomycin was studied over a period of 56. days and potency and cytotoxicity were evaluated. In all treatment groups, gentamicin and tobramycin were completely released within 3. days whilst vancomycin was released over a period of 14. days. The results clearly show that the main parameter influencing release is the molecular weight of the drug. Growth of Staphylococcus aureus was inhibited in all 3 treatment groups for at least 3. days. Cell viability and alkaline phosphatase activity of primary osteoblast-like cells were not significantly affected by the antibiotic concentrations obtained from the elution experiments.Bone grafting is an established component of surgery for bone defect filling and for biological stimulation of healing. Patient-specific enhancement of such procedures by incorporation of antibiotics for infection prevention or by addition of cytokines for promotion of impaired healing or for treatment of critical size defects will be a relevant issue in the future. © 2013 Elsevier Inc. Source

Knels R.,Eurocode International Blood Labeling System E.V. | Monig H.-J.,German Institute for Cell and Tissue Replacement | Wittmann G.,Klinikum der LMU Munich Grosshadern | Von Versen R.,VVC Von Versen International Consultants | Pruss A.,Charite - Medical University of Berlin
Cell and Tissue Banking | Year: 2010

Due to their limited availability and compatibility, biological products must be exchanged between medical institutions. In addition to a number of national systems and agreements which strive to implement a unique identification and classification of blood products, the ISBT 128 was developed in 1994, followed by the Eurocode in 1998. In contrast to other coding systems, these both make use of primary identifiers as stipulated by the document ISO/IEC 15418 of the International Organization for Standardization (ISO), and thus provide a unique international code. Due to their flexible data structures, which make use of secondary identifiers, both systems are able to integrate additional biological products and their producers. Tissue and cells also constitute a comparable risk to the recipient as that of blood products in terms of false labeling and the danger of infection. However, in contrast to blood products, the exchange of tissue and cells is much more intensively pursued at the international level. This fact is recognised by Directives 2004/23/EC and 2006/86/EC of the European Union (EU), which demand a standardized coding system for cells and tissue throughout the EU. The 2008 workshop agreement of the European Committee for Standardization (CEN) was unique identification by means of a Key Code consisting of country code corresponding to ISO 3166-1, as well as competent authority and tissue establishment. As agreed at the meeting of the Working Group on the European Coding System for Human Tissues and Cells of the Health and Consumers Directorate-General of the European Commission (DG SANCO) held on 19 May 2010 in Brussels, this Key Code could also be used with existing coding systems to provide unique identification and allow EU traceability of all materials from one donation event. Today Eurocode already uses country codes according to ISO 3166-1, and thus the proposed Key Code can be integrated into the current Eurocode data structure and does not need to be introduced separately. The Eurocode product classification for all products is based on its own unique coding system, which can be accessed over the internet by all users who are not themselves members of Eurocode. In summary, it can be said that the standardized single coding system for tissues and cells requires only unique sections in the data structure such the Key Code to fulfil the requirements of the EU Directive. Thus, various systems currently in place in different EU member states can continue to operate if the Key Code as suggested by the EU is integrated into them. The classification and description of each product characteristic is currently being discussed by the DG SANCO Working Group on the European Coding System for Human Tissues and Cells. Following intensive scrutiny in light of the stipulations laid out in EU Directives 2004/23/EC and 2006/86/EC as well as the CEN/ISSS workshop agreements, the Germany Federal Ministry for Health and organisations representing German tissue establishments under the responsibility of the German Society of Transfusion Medicine and Immunohematology, Working Party "Tissue preparations" proposed in 2009 that Eurocode be adopted for the donor identi-fication and product coding of tissue and cells in Germany. The technical details for implementation have already been completed and are presented in the current article. © Springer Science+Business Media B.V. 2010. Source

Rossner E.,University of Mannheim | Smith M.D.,German Institute for Cell and Tissue Replacement | Petschke B.,German Institute for Cell and Tissue Replacement | Schmidt K.,German Institute for Cell and Tissue Replacement | And 4 more authors.
Cell and Tissue Banking | Year: 2011

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. © Springer Science+Business Media B.V. 2010. Source

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