Safety, Ethics and Regulations

This invaluable resource discusses the saftey, ethics, and regulations of developing stem cell clinical applications. Each chapter is contributed by a preeminent scientist in the field and covers such topics as clinical safety of stem cell gene therapy, the patentability of hESC technologies, international guidelines, challenges to international stem cell clinical trials, worldwide regulations including in emerging markets like China and Taiwan. *

• Saftey, Ethics, and Regulations and the other books in the Stem Cells in Clinical Applications series will be invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering.

Addresses some of the most crucial safety challenges of clinical stem cell applications Provides up-to-date insights on recent regulatory developments in the stem cell fields Examines key ethical issues of the clinical translation process in different socio-economic, regulatory and healthcare contexts Discusses the challenges of regulatory variation and ethical pluralism for international clinical research collaborations Includes supplementary material: sn.pub/extras

Auteur

Phuc Van Pham received his Ph.D. in Human Physiology from Vietnam National University, Ho Chi Minh City, Vietnam. He is currently a Professor of Biology at University of Science (Vietnam National University Ho Chi Minh city, Vietnam); and Director of the Stem Cell Institute; Vice-Director, Key Laboratory of Cancer Research. He is a longstanding lecturer and translational scientist at the University, and is a member of several societies and journal editorial boards focused on stem cells. Dr. Pham and his colleagues have established one of the first multidisciplinary stem cell center in Vietnam, and he has successfully launched an array of technologies in stem cell isolations. His research interests include stem cell isolation, stem cell therapy, mesenchymal stem cells, cancer stem cells, immunotherapy and regenerative medicine and he has published extensively in these areas. After many years of experience as an embryologist, cell biologist, and molecular biologist, c ollaborating with leading researchers in Singapore, Japan, and the United States, Dr. Pham is a student again, keen to reach beyond the traditional boundaries of biology. Achim Rosemann is a Research Fellow in the Centre for Education Studies at the Faculty of the Social Sciences, University of Warwick. His research addresses the social, political, regulatory and economic dimensions of life and health science research, with a regional focus on developments in China and East Asia. He has received his PhD in Social Anthropology from the University of Sussex, with a specialization in Science and Technology Studies and Medical Anthropology. He is also a research associate at the Centre for Bionetworking at the University of Sussex.

Contenu

Part I. Safety .- Chapter 1: The safety of allogeneic stem cell transplantation .- Chapter 2: Induced Pluripotent Stem Cell Therapy and Safety Concerns in Age-related Chronic Neurodegenerative Diseases .- Chapter 3: IClinical safety and applications of stem cell gene therapy .- Chapter 4: The safety of non-expanded multipotential stromal cell therapies.- Part II: Ethics and Regulations .- Chapter 5: A Normative Case for the Patentability of Human Embryonic Stem Cell Technologies .- Chapter 6. Ethical Considerations in Stem Cell Research on Neurologic and Orthopedic Conditions .- Chapter 7. New Regulatory Pathways for Stem Cell-Based Therapies: Comparison and Critique of Potential Models.- Chapter 8: Travelling cells Harmonised European Regualtion and the BAMI stem cell trial.- Chapter 9: Oversight and Evidence in Stem Cell Innovation: An Examination of International Guidelines.- Chapter 10: The regulation of clinical stem cell research in China .- Chapter 11: Gov erning Stem Cell Therapies in India.- Chapter 12: Patenting human embryonic stem cells in the European Union context: an updated analysis of a complex issue.- Chapter 13: The regulatory situation for clinical stem cell research in China.- Chapter 14: Contested Tissues: the donation of oocytes and embryos in the IVF-Stem Cell Interface in China.- Chapter 15: Challenges to international stem cell clinical trials in countries with diverging regulations.
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