140 research outputs found
Life without value? : Voices of embryo donors for hESC research in China
No full textTechnoscientifi c projects feature high on the Chinese government’s agenda. The decoding of the rice, chicken and most recently panda genomes have caught the attention of the media and the masses. A no less ambitious plan is the drive to establish China as a key force in human embryonic stem cell (hESC) research. While in the West hESC research has been slowed by ethical and legal debates, a highly permissive regulatory environment has been fostered in China. Achim Rosemann investigates how this corresponds to the perceptions of potential embryo donors
The regulation of clinical stem cell research and applications : three dynamics of global regulatory diversification
No full textThe evolving regulatory landscape for clinical stem cell research is characterized by a conflict between the striving for international harmonization and an increasing process of global regulatory diversification. Attempts of regulatory harmonization are exemplified, for instance, by the 2016 Guidelines for Stem Cell Research and Clinical Translation by the International Society for Stem Cell Research (ISSCR 2016), the Advanced Therapy and Medicinal Products (ATMP) Regulation of the European Medicines Agency (EMA), or by the ATMP Cluster of the US Food and Drug Administration (FDA), EMA and Health Canada (Arcidiacono 2012). These processes of harmonization have evolved from a pharmaceutical model of drug development and the ideal of Evidence-Based Medicine (EBM), with the multiphase randomized controlled trial (RCT) system as methodological gold standard. In parallel to these developments, however, discontent with the use of the multi-phase trial system for the clinical validation of stem cell-based medicinal product has grown. A politics of opposition has emerged that has called for the use of alternative methods and forms of evidence, to reduce the costs of clinical testing and to increase access to non-systematically proven innovative interventions at an earlier stage. Calls for international harmonization in the stem cell field have been undermined too, by practical challenges to standardize clinical and cell processing procedures in large-scale, multi-country trials, which require a complex logistical infrastructure and significant financial resources. For academic researchers and small to mid-size biotech companies these resources are often not available (Rosemann 2014). Since industry involvement in stem cell medicine has remained at a low level, the mobilization of resources to take investigational stem cell products or therapies through rigorous multi-phase trials, remains typically a challenge. This politics of alter-standardization has taken an increasingly global form. Many impulses for regulatory change and a shift away from multi-phase trials for stem cell-based treatments, have come from Asia, especially from Japan, India, China and South Korea (Sleeboom-Faulkner et al. 2016). But opposition to EBM and the multi-phase trial system, and calls for the emerging of new models and methodologies of clinical innovation in the stem cell field has also increasingly evolved in the European Union and the USA. These clashes have resulted in three central dynamics of regulatory diversification. These developments challenge the use of multi-phase trial methodology as the central methodological instrument for therapy development in the stem cell field in many respects
Scientific multipolarisation : its impact on international clinical research collaborations and theoretical implications
No full textThe article explores the contemporary dynamics of global scientific multipolarisation, and the empirical and theoretical implications of this trend for international clinical research collaborations. The focal point of the article is an ethnographic study of the China Spinal Cord Injury Network (China SCI Net), a transcontinental clinical research infrastructure that is active in Mainland China, Hong Kong, Taiwan and the US. Based on findings from this case study, the author suggests that the transition toward a multipolarising science world is associated with significant changes in the ways international collaborations are initiated, organised and justified. For many years, clinical research collaborations between partners in high- and low-to-middle-income countries have involved geographically bound hierarchies between the sponsors, intellectual creators and facilitating technicians of the research. However, the data from the China SCI Net indicate that these boundaries are in important respects transcending, and that a new modality of international clinical research organisation may gradually be taking shape. Theoretically, this article engages in a reflective dialogue with post-colonial theory, and post-colonial science and technology studies. The author suggests that several of the analytical tools that post-colonial science studies offer remain of great relevancy also in the context of a multipolarising science world. Simultaneously, however, the conceptual, methodological and ideological presumptions embedded in post-colonial theory require careful scrutiny, and other complementary strategies are required to capture the impact of the current multipolarisation process in the sciences more completely
[Commentary] The regulation of clinical stem cell research and applications: three dynamics of global regulatory diversification
No full textThe evolving regulatory landscape for clinical stem cell research is characterized by a conflict between the striving for international harmonization and an increasing process of global regulatory diversification. Attempts of regulatory harmonization are exemplified, for instance, by the 2016 Guidelines for Stem Cell Research and Clinical Translation by the International Society for Stem Cell Research (ISSCR 2016), the Advanced Therapy and Medicinal Products (ATMP) Regulation of the European Medicines Agency (EMA), or by the ATMP Cluster of the US Food and Drug Administration (FDA), EMA and Health Canada (Arcidiacono 2012). These processes of harmonization have evolved from a pharmaceutical model of drug development and the ideal of Evidence-Based Medicine (EBM), with the multiphase randomized controlled trial (RCT) system as methodological gold standard. In parallel to these developments, however, discontent with the use of the multi-phase trial system for the clinical validation of stem cell-based medicinal product has grown. A politics of opposition has emerged that has called for the use of alternative methods and forms of evidence, to reduce the costs of clinical testing and to increase access to non-systematically proven innovative interventions at an earlier stage. Calls for international harmonization in the stem cell field have been undermined too, by practical challenges to standardize clinical and cell processing procedures in large-scale, multi-country trials, which require a complex logistical infrastructure and significant financial resources. For academic researchers and small to mid-size biotech companies these resources are often not available (Rosemann 2014). Since industry involvement in stem cell medicine has remained at a low level, the mobilization of resources to take investigational stem cell products or therapies through rigorous multi-phase trials, remains typically a challenge. This politics of alter-standardization has taken an increasingly global form. Many impulses for regulatory change and a shift away from multi-phase trials for stem cell-based treatments, have come from Asia, especially from Japan, India, China and South Korea (Sleeboom-Faulkner et al. 2016). But opposition to EBM and the multi-phase trial system, and calls for the emerging of new models and methodologies of clinical innovation in the stem cell field has also increasingly evolved in the European Union and the USA. These clashes have resulted in three central dynamics of regulatory diversification. These developments challenge the use of multi-phase trial methodology as the central methodological instrument for therapy development in the stem cell field in many respects
Contested tissues : the donation of oocytes and embryos in the IVF-stem cell interface in China
No full textThe continued significance of human embryonic stem cell research and recent advances in human somatic cell nuclear transfer and human gamete and embryo gene editing have given rise to renewed debates on the donation and use of human embryos and oocytes for research, therapies, and commercial applications. Sociological studies of cell and tissue donation have also indicated that the ethical procedures and social and moral values that surround the donation and use of human reproductive tissues for research do often differ across countries. This chapter addresses the donation of human embryos for human embryonic stem cell research in China. The chapter is based on interviews with 15 IVF clinicians, 15 stem cell researchers, and 15 IVF patients who were asked to donate their embryos for hESC research. Part I focuses on the role and enactment of informed consent procedures. A question that I ask in this respect is what ideas are communicated to potential embryo donors, so that the donation of their spare embryos for hESC research appears reasonable and justifiable? Based on interview data I will illustrate a variety of rhetorical practices and strategies that underpin informed consent procedures. These range from the responsible facilitation of informed choice that emphasizes patient autonomy and the right to refuse donation to more problematic rhetorical practices that involve the provision of false facts and patient deception. Part II discusses these findings in light of the regulatory context in which human embryonic stem cells are produced, banked, and distributed in China. To illustrate the specific effects of this regulatory system, I will draw on a comparison with the regulatory situation in the UK. The chapter concludes that there is often a significant gap between the ways in which the value and use of donated embryos is described to patients and the actual forms of value that these tissues gain in the context of research, distribution, and commercial use. With the renewed importance of human gametes and embryos for human genome editing, these findings indicate that there is the need for more, critical in-depth research into actual donation practices of gametes and embryos and into the needs and perceptions of human tissue donors
Challenges to international stem cell clinical trials in countries with diverging regulations
No full textThis chapter addresses challenges to the organization and conduct of international stem cell clinical trials in a context of regulatory pluralism. Multi-country clinical trial collaborations in stem cell medicine have the potential to speed up clinical developments and to widen access to new treatments among patients. However, the regulatory procedures through which the safety and efficacy of stem cell-based treatments are determined vary widely across countries. Internationally harmonized governance frameworks are not yet in place. In this chapter we show that this high level of regulatory variation and the absence of internationally binding standards for clinical stem cell research present important challenges to multi-country clinical trial collaborations. Four types of challenges will be highlighted. First is the need to inquire into and interact with regulatory procedures and law in multiple countries. Second, the interaction with medical authorities in multiple countries is resulting in a high level of organizational complexity. Third consists of delays, increased costs, and uncertainties that result from nonexistent, unclear, or still emerging regulatory arrangements in different countries. Fourth is that the high level of regulatory variation across countries necessitates far-reaching forms of scientific self-governance, training, and procedural adjustments in participating clinical trial sites. To illustrate this point, the chapter presents a case study of project-internal self-governance and capacity building in the context of a clinical trial infrastructure that is active across the contexts of China, Hong Kong, and the USA. The chapter concludes with a call for the creation of an international support structure that systematically addresses these problems. Five measures that may help to reduce existing difficulties will be introduced
Why regenerative stem cell medicine progresses slower than expected
No full textStem cell research has been acclaimed to revolutionize the future of medicine, and to offer new treatments for previously incurable diseases. Despite years of research, however, the therapeutic potential of stem cell research has not yet been fully realized. By June 2014, the US Food and Drug Administration had approved only five stem cell-based medicinal products, all of which cord blood derived hematopoietic stem cell products for the cure of blood and immunological diseases. Anticipated treatments for cancer, neurodegenerative disorders, gastroenterological, myocardial, and other diseases are still far from routine applications. What are the reasons for the slow progress in the stem cell field, and the mismatch between public expectations and actual achievements
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No full textA Rb1 promoter variant with reduced activity contributes to osteosarcoma susceptibility in irradiated mice Michael Rosemann 1,6,
Multi-country stem cell trials : the need for an international support structure
No full textHighlights
• The paper tackles the organizational challenges of international stem cell trials
• It explores the obstacles that result from regulatory variation across countries
• The article argues for the formation of an international support structure
• Such a structure will be of use to academic and corporate trial sponsors
• Five steps through which such a support structure could be realized are introduce
Modalities of value, exchange, solidarity : the social life of stem cells in China
No full textThe donation of embryos for human embryonic stem cell (hESC) research is commonly framed as an act of solidarity, exemplifying a selfless expression of help from present-day citizens for public health improvements in the future. As I will show at the case of hESC research in the People's Republic of China, however, such discourse conceals the complexities of contemporary stem cell distribution and exchange systems, as well as the concrete forms of value and benefit that the derivation, use and circulation of these tissues has for user communities already in the here and now. While it is clear that the medical, scientific and commercial hopes of hESC research have not yet materialized, I will show that the current regulatory approach of hESC line distribution in China enables the usage of these materials as a resource of power that can be used strategically for the accrual of various forms of influence and value
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