Reference Series in Biomedical Engineering – serie

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 tocover 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 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 is 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 contains 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 is written in an accessible manner that facilitates 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 of this work will be researchers and clinicians based in academic, industrial and healthcare settings all over the world.

The notion of being able to engineer complete organs has inspired an entire generation of researchers. While recent years have brought significant progress in regenerative medicine and tissue engineering, the immense challenges encountered when trying to engineer an entire organ have to be acknowledged. Despite a good understanding of cell phenotypes, cellular niches and cell-to-biomaterial interactions, the formation of tissues composed of multiple cells remains highly challenging. Only a step-by-step approach will allow the future production of a living tissue construct ready for implantation and to augment organ function.In this book, expert authors present the current state of this approach. It offers a concise overview and serves as a great starting point for anyone interested in the application of tissue engineering or regenerative medicine for organ engineering. Each chapter contains a short overview including physiological and pathological changes as well as the current clinical need. The potential cell sources and suitable biomaterials for each organ type are discussed and possibilities to produce organ-like structures are illustrated. The ultimate goal is for the generated small tissues to unfold their full potential in vivo and to serve as a native tissue equivalent. By integrating and evolving, these implants will form functional tissue in-vivo. This book discusses the desired outcome by focusing on well-defined functional readouts. Each chapter addresses the status of clinical translations and closes with the discussion of current bottlenecks and an outlook for the coming years. A successful regenerative medicine approach could solve organ shortage by providing biological substitutes for clinical use - clearly, this merits a collaborative effort.

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.

This reference work gives a comprehensive overview about how to fully exploit the potential of bioimaging to characterize tissue regeneration holistically and to gain complementary, multi-scale information about relevant structure, function, dynamics and molecular composition. To keep pace with the highly dynamic nature of the field and fast-developing imaging technology, it is essential to allow its Live Reference version to be updated and dynamic. It guides the reader through real-case biomedical applications organized by chapter and gives a tissue-specific overview on how to best assess parameters of interest. Additionally, all imaging techniques, including emerging modalities, are explained in great detail and enables the reader to understand the physical principles behind each imaging modality. The book provides a unique overview of available biological and (pre)clinical imaging techniques in the field and enables the reader to understand their benefits and limitations for real-case applications. The reader will be equipped with a comprehensive tool to properly chose the most promising technique for her/his biomedical research question - and respond to novel trends due to the dynamic nature of the Live Reference version available online. The book is of high interest to all researchers, physicians, physicists and life scientists working in the field to deepen their theoretical and practical knowledge about bioimaging and about the wide range of tissue-specific biomedical applications. The book is a valuable reference in the field for bioimaging.

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. There is particular emphasis on current understanding of tissue regeneration based on embryology and evolution studies, including mechanisms of amphibian regeneration. The book covers the use of autologous versus allogeneic cell sources, as well as various procedures used for cell isolation and cell pre-conditioning , such as cell sorting, biochemical and biophysical pre-conditioning, transfection and aggregation. It also presents cell modulation using growth factors, molecular factors, epigenetic approaches, changes in biophysical environment, cellular co-culture and other elements of the cellular microenvironment. The pathways of cell delivery are discussed with respect to specific clinical situations, including delivery of ex vivo manipulated cells via local and systemic routes, as well as activation and migration of endogenous reservoirs of reparative cells. The volume concludes with an in-depth discussion of the tracking of cells in vivo and their various regenerative activities inside the body, including differentiation, new tissue formation and actions on other cells by direct cell-to-cell communication and by secretion of biomolecules.

This volume provides an in-depth introduction to 3D printing and biofabrication and covers the recent advances in additive manufacturing for tissue engineering. The book is divided into two parts, the first part on 3D printing discusses conventional approaches in additive manufacturing aimed at fabrication of structures, which are seeded with cells in a subsequent step. The second part on biofabrication presents processes which integrate living cells into the fabrication process.