Challenges in the clinical application of induced pluripotent stem cells

The advent of human induced pluripotent stem cells has been heralded as a major breakthrough in the study of pluripotent stem cells, for these cells have yielded fundamental insights into the reprogrammability of somatic cell fates, but also because of their seemingly great promise in applications, including potential uses in cell therapy. Several recent reports in the scientific literature and mass media, however, have challenged this concept for reasons of biological function and business feasibility, presenting an important opportunity to re-examine the prospects for human induced pluripotent stem cells in medicine. In this commentary, I will outline a number of hurdles that will need to be cleared if these cells are to fulfil their clinical promise, and suggest avenues that might facilitate these important endeavours

Ethical and Regulatory Challenges with Autologous Adult Stem Cells:A Comparative Review of International Regulations

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. Keywords: Stem cell research, cell therapy, bioethics, medical law, science regulatio

Publishing SNP Genotypes of Human Embryonic Stem Cell Lines: Policy Statement of the International Stem Cell Forum Ethics Working Party

Novel methods and associated tools permitting individual identification in publicly accessible SNP databases have become a debatable issue. There is growing concern that current technical and ethical safeguards to protect the identities of donors could be insufficient. In the context of human embryonic stem cell research, there are no studies focusing on the probability that an hESC line donor could be identified by analyzing published SNP profiles and associated genotypic and phenotypic information. We present the International Stem Cell Forum (ISCF) Ethics Working Party’s Policy Statement on “Publishing SNP Genotypes of Human Embryonic Stem Cell Lines (hESC)”. The Statement prospectively addresses issues surrounding the publication of genotypic data and associated annotations of hESC lines in open access databases. It proposes a balanced approach between the goals of open science and data sharing with the respect for fundamental bioethical principles (autonomy, privacy, beneficence, justice and research merit and integrity)

Marketing of unproven stem cell-based interventions:A call to action

Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that has proven resistant to regulatory efforts. Here, we suggest a coordinated approach at the national and international levels focused on engagement, harmonization, and enforcement to reduce the risks associated with direct-to-consumer marketing of unproven stem cell treatments

Downgrading of regulation in regenerative medicine

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