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.

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.

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.

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

The skin is the largest human organ system. Loss of skin integrity due to injury or illness results in a substantial physiologic imbalance and ultimately in severe disability or death. From burn victims to surgical scars and plastic surgery, the therapies resulting from skin tissue engineering and regenerative medicine are important to a broad spectrum of patients. Skin Tissue Engineering and Regenerative Medicine provides a translational link for biomedical researchers across fields to understand the inter-disciplinary approaches which expanded available therapies for patients and additional research collaboration. This work expands on the primary literature on the state of the art of cell therapies and biomaterials to review the most widely used surgical therapies for the specific clinical scenarios. - Explores cellular and molecular processes of wound healing, scar formation, and dermal repair - Includes examples of animal models for wound healing and translation to the clinical world - Presents the current state of, and clinical opportunities for, extracellular matrices, natural biomaterials, synthetic biomaterials, biologic skin substitutes, and adult and fetal stem and skin cells for skin regenerative therapies and wound management - Discusses new innovative approaches for wound healing including skin bioprinting and directed cellular therapies

Frontiers in Tissue Engineering is a carefully edited compilation of state-of-the-art contributions from an international authorship of experts in the diverse subjects that make up tissue engineering. A broad representation of the medical, scientific, industrial and regulatory community is detailed in the book. The work is an authoritative and comprehensive reference source for scientists and clinicians working in this emerging field. The book is divided into three parts: fundamentals and methods of tissue engineering, tissue engineering applied to specialised tissues, and tissue engineering applied to organs. The text offers many novel approaches, including a detailed coverage of cell-tissue interactions at cellular and molecular levels; cell-tissue surface, biochemical, and mechanical environments; biomaterials; engineering design; tissue-organ function; new approaches to tissue-organ regeneration and replacement of function; ethical considerations of tissue engineering; and government regulation of tissue-engineered products.

Advances in Tissue Engineering is a unique volume and the first of its kind to bring together leading names in the field of tissue engineering and stem cell research. A relatively young science, tissue engineering can be seen in both scientific and sociological contexts and successes in the field are now leading to clinical reality. This book attempts to define the path from basic science to practical application. A contribution from the UK Stem Cell Bank and opinions of venture capitalists offer a variety of viewpoints, and exciting new areas of stem cell biology are highlighted. With over fifty stellar contributors, this book presents the most up-to-date information in this very topical and exciting field./a

Myocardial tissue engineering (MTE), a concept that intends to prolong patients’ life after cardiac damage by supporting or restoring heart function, is continuously improving. Common MTE strategies include an engineered ‘vehicle’, which may be a porous scaffold or a dense substrate or patch, made of either natural or synthetic polymeric materials. The function of the substrate is to aid transportation of cells into the diseased region of the heart and support their integration. This book, which contains chapters written by leading experts in MTE, gives a complete analysis of the area and presents the latest advances in the field. The chapters cover all relevant aspects of MTE strategies, including cell sources, specific TE techniques and biomaterials used. Many different cell types have been suggested for cell therapy in the framework of MTE, including autologous bone marrow-derived or cardiac progenitors, as well as embryonic or induced pluripotent stem cells, each having their particular advantages and disadvantages. The book covers a complete range of biomaterials, examining different aspects of their application in MTE, such as biocompatibility with cardiac cells, mechanical capability and compatibility with the mechanical properties of the native myocardium as well as degradation behaviour in vivo and in vitro. Although a great deal of research is being carried out in the field, this book also addresses many questions that still remain unanswered and highlights those areas in which further research efforts are required. The book will also give an insight into clinical trials and possible novel cell sources for cell therapy in MTE.