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Cardiovascular diseases are still the leading cause of death in developed countries. Revascularization procedures such as coronary artery and peripheral bypass grafts, as well as access surgery represent a 2$ billion market yearly for the US alone. Despite intense research over many decades, no clinically suitable, shelf-ready, synthetic, vascular, small-caliber graft exists. There is therefore still a quest for such a clinical vascular prosthesis for surgical revascularization procedures and access surgery. Many approaches have been tried and are currently under investigation with promising results. These range from acellular and cell-based, stable or bio-degradable, synthetic scaffolds to biological or decellularized grafts, not forgetting self-assembly technologies for in vitro or in vivo VTE. All these approaches can be further enhanced by functionalization, e.g. with growth factors and drug elution. This updatable book aims to cover all the relevant aspects of Vascular Tissue Engineering (VTE) and novel alternatives to develop vascular grafts for clinical applications. The chapters in this book cover different aspects of manufacturing scaffolds with various polymers, mechanical characteristics, degradation rates, decellularization techniques, cell sheet assembly, 3-D printing and autologous mandril-based VTE. All the necessary in vitro tests such as biocompatibility and thrombogenicity are reviewed. Pre-clinical assessment of in vivo experimental models include patency, compliance, intimal hyperplasia, inflammatory reaction, cellular ingrowth and remodeling. Finally, early clinical trials will be periodically updated regarding results, regulatory aspects and post-marketing quality assessment. Furthermore, the reader should get an insight into various approaches, technologies and methods to better understand the complexity of blood surface and cell interactions in VTE. Translational research has yielded early human applications clearly showing the enormous need of research in the field to provide better solutions for our patients and this continuously updated book will hopefully become a reference in the field for life sciences.
This updatable book provides an accessible informative overview of the current state of the art in nerve repair research.The introduction includes history of nerve repair research and establishes key concepts and terminology and will be followed by sections that represent the main areas of interest in the field: (1) Biomaterials, (2) Therapeutic Cells, (3) Drug, Gene and Extracellular Vesicle Therapies, (4) Research Models and (5) Clinical Translation. Each section will contain 3 - 6 chapters, capturing the full breadth of relevant technology. Bringing together diverse disciplines under one overarching theme echoes the multidisciplinary approach that underpins modern tissue engineering and regenerative medicine. Each chapter will be written in an accessible manner that will facilitate interest and understanding, providing a comprehensive single reference source. The updatable nature of the work will ensure that it can evolve to accommodate future changes and new technologies. The main readership for this work will be researchers and clinicians based in academic, industrial and healthcare settings all over the world.
This reference work presents the origins of cells for tissue engineering and regeneration, including primary cells, tissue-specific stem cells, pluripotent stem cells and trans-differentiated or reprogrammed cells.
These include pre-vascularization strategies using preparation of channeled scaffolds and preparation of decellularized blood vessel trees, approaches to inducing formation of microvasculature and approaches to inducing the growth of vascular networks.
This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medicalstudents who are preparing themselves for a professional career in the medical technlogy industries.
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