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Stem cell research, and particularly embryonic stem cell research, while offering the prospect of developing theories for serious life-threatening diseases, also raises a number of difficult and controversial moral questions. This is reflected in a variety of moral perspectives and regulatory regimes, already adopted or in the process of being developed, in EU Member States. In particular the "moral exclusion" clause in Article 6 of the EC Directive on the legal protection of biotechnological inventions has created much uncertainty in this field. This collection of original essays provides comprehensive analysis of the EU patent system as applied to biotechnological inventions and particularly stem cell research, dealing with the overlapping EPC, EU, international and national law regimes bearing on the exclusion of patents in a morally fragmented and contested field. In this multidisciplinary study, the editors aim to clarify the legal scope of Article 6, which they deem essential for the fostering of research and investment in Europe, while ensuring that such research is conducted within clear ethical limits which address the concerns of society. As well as a complete overview of the application of the European patent law in the field of human embryonic stem cells, topics covered include legal and philosophical accounts of the boards of the European Court of Justice and European Patent Offices' reasoning in the leading litigated cases, as well as the institutional tensions between national and transnational European research and patent regimes. With its broad research in the fields of patent law, ethics and philosophy, the book analyzes a wide range of issues in a way no other book has previously done and suggests solutions to unblock the current stalemate surrounding the patentability of human embryonic stem cell related inventions. The book will be welcomed by a broad readership, including experts and academics in both ethical and legal disciplines as well as policy makers and regulators in the field of embryonic stem cell research in Europe.
This manual is a comprehensive compilation of "methods that work" for deriving, characterizing, and differentiating hPSCs, written by the researchers who developed and tested the methods and use them every day in their laboratories. The manual is much more than a collection of recipes; it is intended to spark the interest of scientists in areas of stem cell biology that they may not have considered to be important to their work. The second edition of the Human Stem Cell Manual is an extraordinary laboratory guide for both experienced stem cell researchers and those just beginning to use stem cells in their work. - Offers a comprehensive guide for medical and biology researchers who want to use stem cells for basic research, disease modeling, drug development, and cell therapy applications - Provides a cohesive global view of the current state of stem cell research, with chapters written by pioneering stem cell researchers in Asia, Europe, and North America - Includes new chapters devoted to recently developed methods, such as iPSC technology, written by the scientists who made these breakthroughs
Recent scientific breakthroughs, celebrity patient advocates, and conflicting religious beliefs have come together to bring the state of stem cell researchâ€"specifically embryonic stem cell researchâ€"into the political crosshairs. President Bush's watershed policy statement allows federal funding for embryonic stem cell research but only on a limited number of stem cell lines. Millions of Americans could be affected by the continuing political debate among policymakers and the public. Stem Cells and the Future of Regenerative Medicine provides a deeper exploration of the biological, ethical, and funding questions prompted by the therapeutic potential of undifferentiated human cells. In terms accessible to lay readers, the book summarizes what we know about adult and embryonic stem cells and discusses how to go about the transition from mouse studies to research that has therapeutic implications for people. Perhaps most important, Stem Cells and the Future of Regenerative Medicine also provides an overview of the moral and ethical problems that arise from the use of embryonic stem cells. This timely book compares the impact of public and private research funding and discusses approaches to appropriate research oversight. Based on the insights of leading scientists, ethicists, and other authorities, the book offers authoritative recommendations regarding the use of existing stem cell lines versus new lines in research, the important role of the federal government in this field of research, and other fundamental issues.
Perinatal Stem Cells provides researchers and clinicians with a comprehensive description of the current clinical and pre-clinical applications of stem cells derived from perinatal sources, such as amniotic fluid, placenta and placental membranes, the umbilical cord and Wharton’s jelly. It's compiled by leading experts in the field, offering readers detailed insights into sources of perinatal stem cells and their potential for disease treatment. Therapeutic applications of perinatal stem cells include the treatment of in utero and pregnancy related diseases, cardiac disease, liver disease, pulmonary disease, inflammatory diseases, for hematopoietic regeneration, and for neural protection after stroke or traumatic brain injury. In addition, the rapid advance in clinical translation and commercialization of perinatal stem cell therapies is highlighted in a section on Clinical and Industry Perspective which provides insight into the new opportunities and challenges involved in this novel and exciting industry. Explores current clinical and pre-clinical application of stem cells derived from perinatal sources Offers detailed insight into sources of perinatal stem cells and their potential for disease treatment Discusses progress in the manufacturing, banking and clinical translation of perinatal stem cells Edited by a world-renowned team to present a complete story of the development and promise of perinatal stem cells
A discussion of all the key issues in the use of human pluripotent stem cells for treating degenerative diseases or for replacing tissues lost from trauma. On the practical side, the topics range from the problems of deriving human embryonic stem cells and driving their differentiation along specific lineages, regulating their development into mature cells, and bringing stem cell therapy to clinical trials. Regulatory issues are addressed in discussions of the ethical debate surrounding the derivation of human embryonic stem cells and the current policies governing their use in the United States and abroad, including the rules and conditions regulating federal funding and questions of intellectual property.
The second edition of Stem Cells: Scientific Facts and Fiction provides the non-stem cell expert with an understandable review of the history, current state of affairs, and facts and fiction of the promises of stem cells. Building on success of its award-winning preceding edition, the second edition features new chapters on embryonic and iPS cells and stem cells in veterinary science and medicine. It contains major revisions on cancer stem cells to include new culture models, additional interviews with leaders in progenitor cells, engineered eye tissue, and xeno organs from stem cells, as well as new information on "organs on chips" and adult progenitor cells. In the past decades our understanding of stem cell biology has increased tremendously. Many types of stem cells have been discovered in tissues that everyone presumed were unable to regenerate in adults, the heart and the brain in particular. There is vast interest in stem cells from biologists and clinicians who see the potential for regenerative medicine and future treatments for chronic diseases like Parkinson's, diabetes, and spinal cord lesions, based on the use of stem cells; and from entrepreneurs in biotechnology who expect new commercial applications ranging from drug discovery to transplantation therapies. - Explains in straightforward, non-specialist language the basic biology of stem cells and their applications in modern medicine and future therapy - Includes extensive coverage of adult and embryonic stem cells both historically and in contemporary practice - Richly illustrated to assist in understanding how research is done and the current hurdles to clinical practice
Introduction -- Defining the public interest in the US and European patent systems -- Confronting the questions of life-form patentability -- Commodification, animal dignity, and patent-system publics -- Forging new patent politics through the human embryonic stem cell debates -- Human genes, plants, and the distributive implications of patents -- Conclusion
Report of an inquiry concerned with two broad issues: the patenting of genetic materials and technologies, and the exploitation of these patents and the distinction that can and possibly should be made between discoveries and inventions when referring to claims over genetic sequences.
This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.
Progenitor and stem cells have the ability to renew themselves and change into a variety of specialised types, making them ideal materials for therapy and regenerative medicine. Progenitor and stem cell technologies and therapies reviews the range of progenitor and stem cells available and their therapeutic application.Part one reviews basic principles for the culture of stem cells before discussing technologies for particular cell types. These include human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells. Part two discusses wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies. The final part of the book considers the therapeutic use of stem and progenitor cells. Chapters review the use of adipose tissue-derived stem cells, umbilical cord blood (UCB) stem cells, bone marrow, auditory and oral cavity stem cells. Other chapters cover the use of stem cells in therapies in various clinical areas, including lung, cartilage, urologic, nerve and cardiac repair.With its distinguished editor and international team of contributors, Progenitor and stem cell technologies and therapies is a standard reference for both those researching in cell and tissue biology and engineering as well as medical practitioners investigating the therapeutic use of this important technology. - Reviews the range of progenitor and stem cells available and outlines their therapeutic application - Examines the basic principles for the culture of stem cells before discussing technologies for particular cell types, including human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells - Includes a discussion of wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies