br The ethics of cell therapy Clearly then cell

The ethics of cell therapy Clearly then, cell therapy and regenerative medicine in general raise a number of ethical, economical and regulatory issues that were addressed in an ad hoc session. As a general introduction to this very complex landscape, John Harris (University of Manchester) took lead from vintage and recent cases such as in vitro polo-like kinase 1 and germ cell genome editing (Chan et al., 2015), to discuss how science and technology should harness public support while deflecting the emotional reactions that may affect the development of the field and its impact on patients\' expectancies and their quality of life. This consideration leads to the subsequent question; i.e., how do we make appropriate judgments on what is best for the “public good” and eventually help inform the decisions of policy makers in such a rapidly evolving field? David Napier (University College London) offered an example by discussing how and why scientists, bioethicists and economists should prioritize highly individualized and very expensive therapies, whose development impacts directly or indirectly on the general population. Setting aside the unregulated stem cell “therapies,” the conundrum presented by the social and ethical justification for these new therapies remains evident. It was pointed out, however, that if found to be really efficacious, these therapies would actually lead to a significant economic benefit by eliminating the long lasting and expensive palliative therapies, and returning patients to a normal and productive life. Finally, from a legal standpoint, the advancement of regenerative medicine, while protected by “The right and liberty of scientific research,” as explicitly recognized by the Constitutions of several European countries and by the European Union, impinges on the liberty and dignity of those involved in scientific research and experimental trials. Amedeo Santosuosso (University of Pavia) underlined how scientific research should not supersede the liberty and dignity of patients (and relatives) involved, and experimentation must be carried out according to rules accepted within the scientific community. These rules should guarantee that patients are not exposed to avoidable and harmful risks, especially without a fully open and understandable informed consent. Therefore, legislators cannot impose (within the constraints outlined above) technical and medical standards to researchers and physicians, nor should the judiciary impose administration of a non-validated, unapproved experimental therapy. The legal aspects are obviously very complex and challenging not only for the scientists, who have to offer safe criteria to the community, but also for jurists and courts, who must accept that rights (even fundamental ones) do not necessarily come first (Santosuosso et al., 2007). Clearly, a single session in a meeting could not possibly address all the important legal and ethical issues that cell therapy faces and will face in the future, but it is of fundamental importance to bring together the different communities and encourage them to openly discuss these overarching issues.
Conclusions
Introduction Hepatic differentiation of patient-derived induced pluripotent stem cells (iPSCs) constitutes a unique in vitro approach to analyze hepatic biology in the context of the genetic background of the patient, and could also hold the key to the large production of hepatocytes for autologous transplantation. Several protocols of hepatic differentiation of human hPSCs have been described recently (Basma et al., 2009; Si Tayeb et al., 2010; Sullivan et al., 2010). They rely on a multi-step process in which the treated cells go through a definitive endoderm stage induced by treatment of colony-type culture of hiPSC with Activin A, followed by hepatic specification to commit the cells toward the hepatic lineage. Finally cells are matured in vitro to obtain albumin-positive cells, which structurally look like mature hepatocytes. Functional assays demonstrate that these hepatocytes-like cells (HLCs) also secrete albumin, metabolize urea, recapitulate lipid metabolism, and express various isoforms of the cytochrome p450.