Translating stem cells to the clinic: scientific societies and the making of regenerative medecine

Dans cet article, l’auteur présentera deux corpus de lignes directrices professionnelles établies par deux sociétés savantes œuvrant dans le domaine de la médecine régénérative utilisant des cellules souches : la « Société internationale pour la recherche sur les cellules souches » (ISSCR) et la « Société internationale de médecine cellulaire » (ICMS). Ces lignes directrices présentent des points de vue divergents sur la façon dont les cellules souches devraient être utilisées en thérapie pour les patients. Elles démontrent l’existence de postures alternatives pour l’encadrement de l’utilisation clinique de ces cellules en s’appuyant sur des hypothèses ontologiques, épistémologiques, éthiques et réglementaires différentes. Ces deux interprétations radicalement opposées sur la façon dont les cellules souches devraient être transposées pour des applications cliniques, s’ancrent respectivement sur des postures narratives soit de normalisation soit de naturalisation. Ces dernières sont envisagées comme des ressources pragmatiques- discursives permettant d’articuler le présent et l’avenir de la médecine régénérative. S’intéresser aux différentes voies de normalisation de la médecine régénérative constitue une véritable opportunité pour une compréhension approfondie de la constitution même des options du passage à l’utilisation clinique des cellules souches. En effet, dans le futur, la médecine régénérative va continuer à évoluer puisque de nouvelles connaissances scientifiques s’accumuleront et de nouvelles pratiques cliniques seront expérimentées. On peut même soutenir que la controverse sera plus importante dans la mesure où les acteurs essaient de construire la cohésion professionnelle et de nourrir la confiance du public dans leurs activités scientifiques. En conséquence, suivre la trajectoire de ces modèles translationnels tels qu’ils sont proposés, contestés, rejetés ou soutenus par les acteurs scientifiques et les autorités réglementaires sera fondamental pour permettre une évaluation critique des régimes d’encadrement qui stabiliseront ce domaine émergent de l’innovation scientifique.In this article I will illustrate two prominent bodies of professional guidance issued by two different scientific societies active in the field of stem cell-based regenerative medicine : the International Society for Stem Cell Research (ISSCR) and the International Cellular Medicine Society (ICMS). These guidelines offer strikingly diverging accounts of how stem cells should be translated into therapies for patients, thus demonstrating the existence of alternative framings of clinical translation relying on diverging ontological, epistemic, ethical and regulatory assumptions. These two radically contrasting interpretations of how stem cells should be translated into clinical applications draw, respectively, on a normalization and on a naturalization narrative as discursive-pragmatic resources to articulate the present and the future of regenerative medicine. Looking at the different routes towards standardization of regenerative medicine provides a timely opportunity for a deeper understanding of the very constitution of translational options. Indeed, regenerative medicine will keep on evolving in the next future as new scientific knowledge will accumulate and new clinical practices will be experimented. Arguably, more controversy will occur as actors try to build professional cohesion and feed public trust in their scientific activities. As a consequence, following the trajectory of these translational models as they are proposed, contested, defeated or supported by scientific actors and regulatory authorities will be key to a critical appraisal of the regulatory regimes that is stabilizing this bursting domain of scientific innovation

Digital health: meeting the ethical and policy challenges

Digital health encompasses a wide range of novel digital technologies related to health and medicine. Such technologies rely on recent advances in the collection and analysis of ever increasing amounts of data from both patients and healthy citizens. Along with new opportunities, however, come new ethical and policy challenges. These range from the need to adapt current evidencebased standards, to issues of privacy, oversight, accountability and public trust as well as national and international data governance and management. This review illustrates key issues and challenges facing the rapidly unfolding digital health paradigm and reflects on the impact of big data in medical research and clinical practice both internationally and in Switzerland. It concludes by emphasising five conditions that will be crucial to fulfil in order to foster innovation and fair benefit sharing in digital health

Open sharing of genomic data: Who does it and why?

We explored the characteristics and motivations of people who, having obtained their genetic or genomic data from Direct-To-Consumer genetic testing (DTC-GT) companies, voluntarily decide to share them on the publicly accessible web platform openSNP. The study is the first attempt to describe open data sharing activities undertaken by individuals without institutional oversight. In the paper we provide a detailed overview of the distribution of the demographic characteristics and motivations of people engaged in genetic or genomic open data sharing. The geographical distribution of the respondents showed the USA as dominant. There was no significant gender divide, the age distribution was broad, educational background varied and respondents with and without children were equally represented. Health, even though prominent, was not the respondents' primary or only motivation to be tested. As to their motivations to openly share their data, 86.05% indicated wanting to learn about themselves as relevant, followed by contributing to the advancement of medical research (80.30%), improving the predictability of genetic testing (76.02%) and considering it fun to explore genotype and phenotype data (75.51%). Whereas most respondents were well aware of the privacy risks of their involvement in open genetic data sharing and considered the possibility of direct, personal repercussions troubling, they estimated the risk of this happening to be negligible. Our findings highlight the diversity of DTC-GT consumers who decide to openly share their data. Instead of focusing exclusively on health-related aspects of genetic testing and data sharing, our study emphasizes the importance of taking into account benefits and risks that stretch beyond the health spectrum. Our results thus lend further support to the call for a broader and multi-faceted conceptualization of genomic utility

Organ chip research in Europe: players, initiatives, and policies

Background: Organ chips are microfabricated devices containing living engineered organ substructures in a controlled microenvironment. Research on organ chips has increased considerably over the past two decades.Aim: This paper offers an overview of the emerging knowledge ecosystem of organ chip research in Europe. Method: This study is based on queries and analyses undertaken through the bibliometric software Dimensions.ai.Results: Organ chip research has been rapidly growing in Europe in recent years, supported by robust academic science consortia, public-private initiatives, dedicated funding, and science policy instruments. Our data shows that previous investment in basic and fundamental research in centers of excellence in bioengineering science and technology are relevant to future investment in organ chips. Moreover, organ chip research in Europe is characterized by collaborative infrastructures to promote convergence of scientific, technical, and clinical capabilities.Conclusion: According to our study, the knowledge ecosystem of organ chip research in Europe has been growing sustainably. This growth is due to relevant institutional diversity, public-private initiatives, and ongoing research collaborations supported by robust funding schemes

Wearable Technologies for Healthy Ageing: Prospects, Challenges, and Ethical Considerations

Digital technologies hold promise to modernize healthcare. Such opportunity should be leveraged also to address the needs of rapidly ageing populations. Against this backdrop, this paper examines the use of wearable devices for promoting healthy ageing. Previous work has assessed the prospects of digital technologies for health promotion and disease prevention in older adults. However, to our knowledge, ours is one of the first attempts to specifically address the use of wearables for healthy ageing, and to offer ethical insights for assessing the prospects of leveraging wearable devices in this context. We provide an analysis of the considerable opportunities associated with the use of wearables for healthy ageing, with a focus on the five domains of intrinsic capacity: locomotion, sensory functions, psychological aspects, cognition, and vitality. We then highlight current limitations and ethical challenges of such approach to healthy ageing, including issues related to access, inclusion, privacy, surveillance, autonomy, and regulation. We conclude by discussing the implications of our analysis in light of current debates on the ethics of digital health, and suggest measures to address the identified challenges

Cancer Biomarkers: Ethics, Economics and Society

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Ethics review of big data research: what should stay and what should be reformed?

Background Ethics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts. Main text In this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science. Conclusions We believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large

La creazione di ibridi e chimere tra scienza e bioetica

Present adress for Alessandro Blasimme: INSERM UMR 1027, Université de Toulouse 3-Paul SabatierInternational audienceL'autore vuole chiarire i termini di una questione molto dibattuta: la creazione di artefatti biologici interspecifici, anche noti nel gergo della medicina e della bioetica come Human/non-Human Interspecifics (HNHIs). La stampa non scientifica li chiama "embrioni chimera", suscitando lo sconcerto e l'orrore del vasto pubblico. La prima parte dell'articolo è una dettagliata classificazione delle tecniche utilizzate in campo biomedico per ottenere linee cellulari da materiale biologico proveniente da specie diverse, a cui segue la descrizione degli obiettivi conoscitivi e applicativi perseguiti dagli scienziati. In particolare l'autore descrive i protocolli scientifici intrapresi in questi anni e dettaglia il significato dei termini chimera interspecifica, embrione animale chimerico, embrione umano chimerico, embrione ibrido, embrione transgenico e ibrido citiplasmatico o cibrido (cybrid). La seconda parte affronta gli aspetti morali legati a queste tecniche