Podiumsdiskussion: Stem Cell Research. Regulatory and Ethical Challenges at the Threshold of Application

Balancing Social Justice and Risk Management in the Regulation of Clinical Stem Cell Research
Achim Rosemann, Social Anthropology, University of Warwick; Postdoctoral Researcher at the Bionetworking in Asia Project; Co-Developing the Research Cluster on Life Sciences, Society and Education at Warwick

tba
Klaus Tanner, Theology, University of Heidelberg; Chairman of ZES; Principle Investigator in the BMBF-project The Patent System as a Medium of Ethicisation and Politicisation of Stem Cell Research

Translational research using induced pluripotent stem cells (IPSC): Between patients’ expectations and ethical regulations
Zacharias Kohl, Senior Physician, Department of Molecular Neurology, University Clinic Erlangen; Principle Investigator in the Bavarian Research Network Induced Pluripotent Stem Cells (ForIPS)

Interdisciplinary Panel Discussion with all Speakers:

Stem cell technology is rapidly moving into applications with large numbers of ongoing clinical trials, experimental medical treatments and uses of stem cells for pharmaceutical tests. The emerging clinical and commercial application challenges regulatory agencies worldwide. Among those challenges are international harmonization or standards, the formation of different marketing practices, and disagreements about evidence criteria between lab and clinical researchers. The guidelines for safe clinical translation by the International Society for Stem Cell Research (ISSCR) have been criticized as impeding rapid progress because they prescribe time-consuming and costly procedures and built upon the infrastructure provided by big pharmaceutical companies, disadvantaging other routes to clinical innovation and poorer countries. There is huge diversity in how governments implement international standards and adjust them to local conditions and needs. A complex web of regulations must be navigated to avoid over-regulation and allow enough flexibility for local economic and scientific development. The tensions between ethical, legal and practical demands are the topic of this pubic conference.

Abstracts of the talks:

European Regulations and their effects on clinical trials
Christine Hauskeller

European regulation has been harmonised to create a unified platform that enables innovation in regenerative medicine. This regulation applies also to all new stem cell clinical trials. Findings from observing a phase III clinical trial indicate that it was unexpectedly difficult to conduct. Many problems arose directly and indirectly following the recent harmonisation of implementation rules to the EU Cells and Tissue Directive. Laws and regulations may be drawn up to protect patients and moral values, they also directly influence research and innovation pathways. By treating all new stem cell therapies the same, comparatively straight forward clinical trials with adult cells and led by clinicians become especially unfeasible. The harmonised regulation has undermined any meaningful connection between the stringency of regulations and controls and the clinical risks and complexity of any specific stem cell treatment. Stem cell research that is not geared toward industrial cell-based products and is not patentable becomes undoable, and that under the premise of making sure morally problematic and risky stem cell science is properly governed in Europe.

Balancing Social Justice and Risk Management in the Regulation of Clinical Stem Cell Research
Achim Rosemann

The regulation of the ways in which emerging fields of medicine are translated from the lab bench to the clinic and the market is at present in the midst of a global renegotiation process. Established ethical norms, clinical research methods, standards and the forms of evidence through which promissory medical approaches are tested and validated are increasingly contested and subjected to change. Stem cell medicine provides an important window to gain insights into these controversies, and into the ways in which researchers, patients, corporations and regulatory authorities respond to these processes. One analytical dimension through which current forms of resistance and regulatory change in stem cell medicine and other emerging fields of medicine research can be explained is a concern with issues related to social justice. As I will show, at the heart of current conflicts on regulatory standards and evidence criteria is a tension between the management of technology risks and the realization of social justice, conceptualized not only in terms of access to new technology products and benefits, but also in terms of access to new innovation and market opportunities by researchers and technology producers. Indeed, the use of the language of social justice has evolved to an important political tool in a struggle for deregulation, the rejection of multi-phase trials and the promotion of “right-to-try” medicine. These calls for alternative standards and practices have important geographic dimensions. Resistance to the high costs of evidence-based medicine has emerged in particular in the context of low-to-middle income countries, but has become increasingly common also in high-income countries, such as Japan and the USA. The presentation explores these processes and also engages in a brief dialogue with existing academic explanations of regulatory diversification in the stem cell field, especially Sleeboom-Faulkner et al.’s notion of “national home-keeping” and Salter, Zhou and Datta’s conceptions of “biomedical hegemony” and “biomedical adaptation”. The presentation reveals that in light of the specific risks of stem cell medicine, very particular challenges for the realization and management of social justice claims emerge. This raises important questions with regard to the role, limits and the theorization of the social justice concept, not only in the governance of new medicines but also in other areas of technology research.

Translational research using induced pluripotent stem cells (IPSC): Between patients’ expectations and ethical regulations
Zacharias Kohl

The generation of human induced pluripotent stem cells (iPSCs) from somatic cells obtained from adult donors provides new opportunities for stem cell based research, e.g. for neurodegenerative diseases. The Bavarian research network induced pluripotent stem cells (ForIPS) uses iPSC derived neural cells as specific cellular models to analyze the pathogenesis of Parkinson’s disease (PD). Moreover, the consortium establishes a biobank for IPSCs and their derivates from PD patients and healthy controls. While the generation of iPSCs circumvents ethical limitations arising from the destruction of human embryos, several new issues emerge with the spread of iPSC technology: Here, informed consent to the generation, storage and distribution of iPSCs and their derivates are of high relevance. Further aspects are the potential tumorigenicity of iPSCs, or the production of germ cells from iPSCs. These ethical concerns face enormous hopes and expectations from patients with PD and related neurodegenerative diseases for the development on new therapeutic options.