Translational Stem Cell Research Issues Beyond the Debate on the Moral Status of the Human Embryo

For many years, the ethical discussion surrounding human embryonic stem cell research has focused on the moral status of the embryo. This text takes a wider moral berth and focuses on numerous ethical, legal and social aspects involved in translating the results of stem cell research into diagnostic and therapeutic applications. Translational Stem Cell Research is broken into ten sections. It opens with an overview of the latest in stem cell research, focusing on specific diseases and the treatment of burn victims. Part II discusses the issues involved in the many steps from bench to bedside, ranging from first research in vitro to clinical trials. Part III covers scientific, regulatory and ethical challenges to basic research, and Part IV details issues regarding stem cell banks. Part V explores ethical, economic and strategic issues involved in collaboration between universities and industry, and Part VI addresses legal problems raised by patents on human stem-cell based inventions plus the extent to which there can be technological solutions to a moral dilemma. Part VII presents imaginative ways of communicating research to the general public and how to create conditions for a constructive dialogue. Part VIII probes psychosocial and cultural factors affecting judgment and decisions about translational stem cell research, and Part IX explores problems and procedures raised by an examination of the evaluation of stem cell research projects in research ethics committees. The book closes with a look into the future of translational stem cell research and stem cell-based therapeutic applications.

PREFACE.- BIOSKETCHES.- SECTION I: TRANSLATIONAL STEM CELL RESEARCH: WHAT IS POSSIBLE TODAY AND WHAT STILL REMAINS TO BE ACHIEVED?- Chapter 1. Towards clinical application of stem cells in neurodegenerative disorders (Olle Lindvall and Zaal Kokaia).- Chapter 2. Treating cardiac disorders with stem cells (Christine Mummery).- Chapter 3. Treating diabetes (Mattias Hansson and Ole D. Madsen).- Chapter 4. Treating oncologic diseases (Peter W. Andrews).- Chapter 5. Clinical application of autologous epithelial stem cells in disorders of squamous epithelia (Nicolas Grasset and Yann Barrandon).- Chapter 6. Towards a cell therapy for Muscular Dystrophy: technical and ethical issues (Giulio Cossu).- Chapter 7. Towards modelling and therapy of genetic diseases using pluripotent stem cells (Petr Dvorak).- Chapter 8. Therapeutic possibilities of induced pluripotent stem cells (Harold Ayetey).- Chapter 9. Industrial applications of stem cells (Oliver Brüstle, Michael Rossbach and Manal Bosnali).- Chapter 10. The obstacles on the road to clinical applications of stem cell-based therapies: What has been done to overcome these obstacles and what remains to be done? (Outi Hovatta).- SECTION II. TRANSLATING STEM CELL RESEARCH KNOWLEDGE FROM BENCH TO BEDSIDE: ETHICAL ISSUES.- Chapter 11. Animal use in translational stem cell research and treatment development: Ethical issues (Kate Millar).- Chapter 12. Ethical aspects of stem cell-based clinical translation: research, innovation, and delivering unproven interventions (Jeremy Sugarman and Doug Sipp).- Chapter 13. Translational stem cell research in pediatrics: Ethical issues (Michael Fuchs).- Chapter 14. Experimental stem cell-based therapy in pediatrics: A fictional case study (Kristina Hug and Anders Castor).- SECTION III: CREATION OF HUMAN-ANIMAL ENTITIES FOR TRANSLATIONAL STEM CELL RESEARCH: SCIENTIFIC, ETHICAL AND REGULATORY CHALLENGES.- Chapter 15. Creation of human-animal entities for translational stem cell research:Scientific explanation of issues that are often confused (Neville Cobbe and Val Wilson).- Chapter 16. Creation of human-animal entities for translational stem cell research: Ethical issues (Gisela Badura-Lotter and Marcus Duewell).- Chapter 17. Chimeras + hybrids = chimbrids: Legal aspects (Jochen Taupitz).- SECTION IV: STEM CELL BANKING FOR TRANSLATIONAL STEM CELL RESEARCH OR STEM CELL-BASED THERAPIES.- Chapter 18. Stem cell banks: Reality, roles and challenges (Glyn Stacey).- Chapter 19. Broad consent (Linus Broström and Mats Johansson).- Chapter 20. Banks, repositories and registries of stem cell lines: The challenges to legal regulation (Mette Hartlev).- SECTION V: TRANSLATIONAL STEM CELL RESEARCH AND COMMERCIAL FUNDING.- Chapter 21. Proprietary interests and collaboration in stem cell science: Avoiding anticommons, countering canalization (Matthew Herder).- SECTION VI: PATENTING OF HUMAN STEM CELL-BASED INVENTIONS: SCIENTIFIC, ETHICAL AND REGULATORY ISSUES.- Chapter 22. Legal problems raised by patents on human stem cell-based inventions (Paul L.C. Torremans).- Chapter 23. Patenting of human stem cell-based inventions: Can there be technological solutions to a moral dilemma? (Aliki Nichogiannopoulou).- Chapter 24. Patenting of human stem cell-based inventions: Ethical issues including and beyond the morality clause (Göran Hermerén).- SECTION VII: FROM GENERAL PUBLIC TO RESEARCHERS, AND VICE VERSA: COMMUNICATION ISSUES IN TRANSLATIONAL STEM CELL RESEARCH.- Chapter 25. Ethical, legal and social implications of translational stem cell research: Effects of commercialisation on public opinion and trust of stem cell research (Ubaka Ogbogu and Amy Zarzeczny).- Chapter 26. Patients’ organisations and their opinions: How much have they been taken into consideration when regulating stem cell research? (Mary Baker and Philip Watson).- Chapter 27. Communicating translational stem cell research to the general public: Challenges and suggestions (Sébastien Duprat).-SECTION VIII: TRANSLATIONAL STEM CELL RESEARCH AND ITS PSYCHOLOGICAL IMPLICATIONS.- Chapter 28. Psychosocial and cultural factors affecting judgments and decisions about translational stem cell research (Melissa L. Finucane and Andrew E. Williams).- SECTION IX: ETHICAL EVALUATION OF TRANSLATIONAL STEM CELL RESEARCH PROJECTS IN RESEARCH ETHICS COMMITTEES.- Chapter 29. Ethics and uncertainty: Considerations for the design and review of translational trials involving stem cells (James Anderson and Jonathan Kimmelman).- SECTION X: LOOKING AT THE FUTURE OF TRANSLATIONAL STEM CELL RESEARCH AND STEM CELL-BASED THERAPEUTIC APPLICATIONS: RISKS, LONG-TERM EFFECTS AND PRIORITY SETTING.- Chapter 30. Unruhe und Ungeweissenheit – Stem cells and risks (Nils-Eric Sahlin, Johannes Persson and Niklas Vareman).- Chapter 31. Looking at the future of translational stem cell research and stem cell-based therapeutic applications: Priority setting and social justice (Göran Hermerén).