Stem cell clinical trials

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Life without value? Voices of embryo donors for hESC research in China

Technoscientifi 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

Multi-country stem cell trials : the need for an international support structure

Highlights • 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

[Commentary] The regulation of clinical stem cell research and applications: three dynamics of global regulatory diversification

The 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

Multipolar technoscience: clinical science collaborations in a changing world system

This dissertation focuses on the formation and governance of international clinical research collaborations in the field of regenerative stem cell medicine, and analyzes these processes against the background of the current transition to a multipolarizing scientific world system. The empirical point of departure of this study is an ethnographic analysis of the establishment of a trans-continental academia-centered clinical trials infrastructure, between researchers based in China, Hong Kong and the USA. Field research was carried out in mainland China and Hong Kong amongst scientists, clinical researchers, medical entrepreneurs, government regulators and patients, between April 2010 and May 2011. The dissertation contributes to debates on the processes and challenges that surround the global distribution of evidence-based medicine clinical research standards, and the study of science and globalization in the context of the emergence of new scientific, economic and geopolitical center regions in the world, with a particular focus on literature that comments on the scientific ascent of the People’s Republic of China. The dissertation reveals that the global diffusion of evidence-based clinical research standards, in regenerative stem cell medicine, is accompanied by the surfacing of vital forms of resistance and the creation of novel transnational spaces of alter-standardization, in which less rigorous, physician-based forms of experimental clinical practice are endorsed, publicized and tried to be legitimized. The dissertation uncovers, furthermore, that the creation of internationally standardized research zones, in the clinical stem cell field, is not necessarily a stable or constant process. The implementation of internationally recognized standards can be highly temporary and depends upon activation in specific situational contexts. Multiple modalities of experimental clinical practices continue to exist side by side to each other. Another line of theorization in this study focuses on the contemporary dynamics of global scientific multipolarization, and explores the empirical and theoretical implications of this trend for international clinical research collaborations. The dissertation argues that a new mode of clinical research partnerships may gradually be emerging. Processes of collective financiering and joint-innovation are giving rise to changing patterns of labour division, decision-making, benefit sharing, profit sharing and revised forms of ownership regarding inventions and research data. Based on a reflective engagement with postcolonial approaches to the study of science and technology, the dissertation concludes that new analytical perspectives are required, through which the empirical transformations and impact associated with the move toward a multipolarizing science system, can be captured in a more nuanced, and comprehensive manner

Human embryo gene editing in China: the uncertain legal status of the embryo

In this article we examine processes of ethical deliberation, legislative developments, and social and political factors that have contributed to the emergence of human embryo gene editing as a field of life science research in China. For this purpose, we examine conceptions of the legal status of the human embryo in three domains of China’s legal system: in patent law, in the jurisdictional domain of birth control, and in civil law. Each of these legal domains handles a different conception of the human embryo’s moral and legal status, and in all three the embryo’s status is contested and subject to changes. Our findings suggest that definitions of the legal status of the human embryo in China are at present in the midst of a renegotiation progress, which is driven by a variety of developments and causes. In this paper, we focus on three types of controversies that underlie this renegotiation process and we illustrate the conflicting aspirations, ethical arguments and moral priorities that inform these conflicts. We end this article with three lines of consideration that might structure future studies on this issue

Entre oportunidad y riesgo: regulación, expectativas y políticas CTI para células madre en Argentina

En Argentina las células madre son identificadas por científicos y funcionarios de Ciencia, Tecnología e Innovación (CTI) como una prioridad estratégica. Esta definición de políticas se ve traducida en el creciente esfuerzo estatal para promover la construcción de capacidades en esta tecnología a través de programas, financiamiento y debates para generar un marco regulatorio específico. Este trabajo explora la forma en que se han configurado localmente los procesos de desarrollo de terapias con células madre. Se analiza la tensión entre la construcción de capacidades, expectativas de ingreso económico, esperanzas por sus potenciales aplicaciones terapéuticas y los riesgos que esta tecnología trae aparejados. Se muestra cómo los intentos de generar una normativa específica, impulsada por actores ligados a las políticas de CTI, busca mediar entre el riesgo y las expectativas moldeando la investigación y los productos desarrollados localmente para el posicionamiento nacional como referente internacional en esta tecnología emergente

Human germ line gene editing: why comparative, cross-national studies on public viewpoints are important

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Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies

This paper aims to analyze innovation pathways for stem cell technology in Argentina. Firstly, we present a theoretical perspective on the co-construction of regulation and technology development, positing four main tensions that underlie regulatory building and the shaping of national strategies for regenerative medicine. Regulation is understood as a negotiated process among interests, values, benefits, rewards, and different understandings of safety, efficacy, access and availability. The framework is useful to explore how actors and their visions of desired futures shape the creation of standards and, in turn, how they configure the way these emerging technologies are produced, accessed and used. Secondly, we discuss in detail the Argentine case. We focus on (a) the deployment of state actions on capacity and regulatory building, (b) the creation of new businesses in response to patient expectations, particularly umbilical cord stem cell banks and the supply of experimental treatments, and (c) state-led actions to build a specific regulatory framework (still in the making). Ambiguities and gaps in the current legislation as well as scarce enforcement capabilities configure a legal “grey area” for for-profit experimental treatments. Building a specific regulatory framework is understood to be a part of Science, Technology and Innovation (STI) state agencies’ struggle to govern technology development in terms of national envisaged innovation strategies. Lastly, we show how STI authorities and scientists managed to align a broad coalition of actors that encourage international harmonization strategies, following the pharmaceutical model of drug evaluation based on the multi-phase trial system

Exploring the social, ethical, legal, and responsibility dimensions of artificial intelligence for health - a new column in Intelligent Medicine

open access articleThis essay is the starting point of a new column in Intelligent Medicine that invites interdisciplinary perspectives on the social, ethical, legal, and responsibility aspects of the use of artificial intelligence (AI) in medicine and health care. Papers in this column will examine the practical, conceptual, and policy dimensions of the use of AI for health-related purposes from comparative and international perspectives. We invite contributions from around the world in all application areas of AI for health, including health care, health research, drug development, health care system management, and public health and public health surveillance. The column aims to provide a forum for reflective and critical scholarship that contributes to the ongoing academic and policy debates about the development, use, governance, and implications of AI in medical and health care settings. We first provide an overview of recent approaches that have been developed to identify and address the effects and ramifications of science and technology innovations on human societies and the environment. These include ethical, legal, and social implications/aspects (ELSI/A) research, responsible research and innovation (RRI), sustainability transitions research, and the use of international standard-setting frameworks for responsible and open science issued by the United Nations Educational, Scientific, and Cultural Organization (UNESCO), the World Health Organization (WHO), and other international bodies. In Part Two of this essay, we discuss some of the central challenges that arise with regard to the integration of AI and big data analytics in medical and health care settings. This includes concerns regarding (i) the control, reliability, and trustworthiness of AI systems, (ii) privacy and surveillance, (iii) the impact of AI and automation on health care staff employment and the nature of clinical work, (iv) the effects of AI on health inequalities, justice, and access to medical care, and (v) challenges related to regulation and governance. We end the essay with a call for papers and a set of questions that could be relevant for future studies