Written by an international group of industry experts, regulators, and academics, this new ASTM publication provides the latest data on tissue engineering and the standards available for manufacturing TEMPs. Twenty-three peer-reviewed papers cover current technology, existing standards, development of new standards, and international standards used by regulatory bodies.
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
The increased use of biodegradable synthetic or natural scaffolds combined with cells and/or biological molecules, in order to create functional replacement tissue in a damaged tissue site, has led to the need for the development of 'best practice' methods in the area of tissue engineering to help ensure the creation of safe, high quality products. Standardisation in cell and tissue engineering introduces concepts and current practice in the field of cell and tissue engineering to a wide audience and aims to provide awareness of the importance of standardisation in this area while suggesting directions for further investigation.Part one provides an overview of methods for cell and tissue engineering and includes chapters on the fundamentals of cell and matrix biology for tissue engineering, 3D collagen biomatrix development, and control and vascularisation of tissue-engineered constructs. Part two begins with a chapter exploring the methods and protocols of standardisation in cell and tissue engineering before moving on to highlight issues of quality control in cell and tissue engineering, standardised chemical analysis and testing of biomaterials and principles of good laboratory practice (GLP) for in vitro cell culture applications.Standardisation in cell and tissue engineering is a standard reference for leading research groups, government agencies, regulatory bodies, and researchers and technicians at all levels across the whole range of disciplines using cell culture within the pharmaceutical, biotechnology and biomedical industries. - Introduces concepts and current practice in the field of cell and tissue engineering - Highlights the importance of standardisation in cell and tissue engineering and suggests directions for further investigation - Explores methods and protocols of standardisation in cell and tissue engineering and issues of quality control in cell and tissue engineering
Nanotechnology and high-end characterization techniques have highlighted the importance of the material choice for the success of tissue engineering. A paradigm shift has been seen from conventional passive materials as scaffolds to smart multi-functional materials that can mimic the complex intracellular milieu more effectively. This book presents a detailed overview of the rationale involved in the choice of materials for regeneration of different tissues and the future directions in this fascinating area of materials science with specific chapters on regulatory challenges & ethics; tissue engineered medical products.
Translational Regenerative Medicine is a reference book that outlines the life cycle for effective implementation of discoveries in the dynamic field of regenerative medicine. By addressing science, technology, development, regulatory, manufacturing, intellectual property, investment, financial, and clinical aspects of the field, this work takes a holistic look at the translation of science and disseminates knowledge for practical use of regenerative medicine tools, therapeutics, and diagnostics. Incorporating contributions from leaders in the fields of translational science across academia, industry, and government, this book establishes a more fluid transition for rapid translation of research to enhance human health and well-being. - Provides formulaic coverage of the landscape, process development, manufacturing, challenges, evaluation, and regulatory aspects of the most promising regenerative medicine clinical applications - Covers clinical aspects of regenerative medicine related to skin, cartilage, tendons, ligaments, joints, bone, fat, muscle, vascular system, hematopoietic /immune system, peripheral nerve, central nervous system, endocrine system, ophthalmic system, auditory system, oral system, respiratory system, cardiac system, renal system, hepatic system, gastrointestinal system, genitourinary system - Identifies effective, proven tools and metrics to identify and pursue clinical and commercial regenerative medicine
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
The opportunity that tissue engineering provides for medicine is extraordinary. In the United States alone, over half-a-trillion dollars are spent each year to care for patients who suffer from tissue loss or dysfunction. Although numerous books and reviews have been written on tissue engineering, none has been as comprehensive in its defining of the field. Principles of Tissue Engineering combines in one volume the prerequisites for a general understanding of tissue growth and development, the tools and theoretical information needed to design tissues and organs, as well as a presentation of applications of tissue engineering to diseases affecting specific organ systems. The first edition of the book, published in 1997, is the definite reference in the field. Since that time, however, the discipline has grown tremendously, and few experts would have been able to predict the explosion in our knowledge of gene expression, cell growth and differentiation, the variety of stem cells, new polymers and materials that are now available, or even the successful introduction of the first tissue-engineered products into the marketplace. There was a need for a new edition, and this need has been met with a product that defines and captures the sense of excitement, understanding and anticipation that has followed from the evolution of this fascinating and important field.Key Features* Provides vast, detailed analysis of research on all of the major systems of the human body, e.g., skin, muscle, cardiovascular, hematopoietic, and nerves* Essential to anyone working in the field* Educates and directs both the novice and advanced researcher* Provides vast, detailed analysis of research with all of the major systems of the human body, e.g. skin, muscle, cardiovascular, hematopoietic, and nerves* Has new chapters written by leaders in the latest areas of research, such as fetal tissue engineering and the universal cell* Considered the definitive reference in the field* List of contributors reads like a "who's who" of tissue engineering, and includes Robert Langer, Joseph Vacanti, Charles Vacanti, Robert Nerem, A. Hari Reddi, Gail Naughton, George Whitesides, Doug Lauffenburger, and Eugene Bell, among others
Biomaterials for Oral and Dental Tissue Engineering examines the combined impact of materials, advanced techniques and applications of engineered oral tissues. With a strong focus on hard and soft intraoral tissues, the book looks at how biomaterials can be manipulated and engineered to create functional oral tissue for use in restorative dentistry, periodontics, endodontics and prosthodontics. Covering the current knowledge of material production, evaluation, challenges, applications and future trends, this book is a valuable resource for materials scientists and researchers in academia and industry. The first set of chapters reviews a wide range of biomaterial classes for oral tissue engineering. Further topics include material characterization, modification, biocompatibility and biotoxicity. Part Two reviews strategies for biomaterial scaffold design, while chapters in parts three and four review soft and hard tissues. - Connects materials science with restorative dentistry - Focuses on the unique field of intraoral tissues - Highlights long-term biocompatibility and toxicity of biomaterials for engineered oral tissues
There is a paradigm shift in plastic and reconstructive surgery from the interest of developing new surgical techniques into the application of new technologies via research based studies on stem cells, tissue engineering and new field of reconstructive transplantation such as e.g. face, hand or larynx transplants. This approach is relatively novel and introduced to plastic surgery within past decade. Thus there is an urgent need to facilitate access to this new knowledge which was not traditionally a part of plastic surgery curriculum. The most efficient way of introducing these new approaches is via presentation of pertinent to different fields (stem cell, transplantation, nerve regeneration, tissue engineering) experimental models which can be used as a tool to develop technologies of interest by different groups of surgeons. These surgical specialities which will be interested and benefit from the book include: plastic and reconstructive surgeons, microsurgeons, hand surgeons, orthopaedic surgeons, neurosurgeons and transplant surgeons.
Characterisation and Design of Tissue Scaffolds offers scientists a useful guide on the characterization of tissue scaffolds, detailing what needs to be measured and why, how such measurements can be made, and addressing industrially important issues. Part one provides readers with information on the fundamental considerations in the characterization of tissue scaffolds, while other sections detail how to prepare tissue scaffolds, discuss techniques in characterization, and present practical considerations for manufacturers. - Summarizes concepts and current practice in the characterization and design of tissue scaffolds - Discusses design and preparation of scaffolds - Details how to prepare tissue scaffolds, discusses techniques in characterization, and presents practical considerations for manufacturers
