Social & Ethical Aspects of the Project

Prenatal stem cell therapy is a field very much in its infancy and the wider application of the technique following successful clinical trials requires an in depth understanding of psychosocial aspects associated with it. We will undertake systematic reviews of literature and develop questionnaires to better understand existing perceptions of this type of treatment. This work will be a collaboration between project partners Karolinska Institutet, Lund University and Great Ormond Street Hospital, each of which bring team members with extensive experience in evaluating these aspects.

Identifying Ethical Concerns ...

A number of ethical issues also arise when considering prenatal stem cell transplantation for OI. These include whether it is ethically sound to offer parents the option of prenatal and/or postnatal transplantation with allogeneic stem cells in severe cases of OI when the prognosis for their child is uncertain and the procedure could provide unrealistic hopes. We also have to consider the ethical implication of whether the child might survive in poor condition after prenatal treatment. In addition we would be using stem cells that have been obtained from fetal tissues after elective termination of pregnancy.

... and Ensuring Oversight

To address these ethical issues, the Department of Medical Ethics at the University of Lund will summarise the present status of the field, examine the risk associated with this therapy and lastly propose ethical criteria for identifying the patient categories that should be approached with information on this treatment and prioritise conflicting interests of different stakeholders (members of Ethical Review Boards, politicians, researchers, clinicians, patient advocates and patients).

Professor Göran Hermerén at University of Lund is currently a member of the National Council on Medical Ethics, Stockholm and chair of the permanent working group for science and ethics of ALLEA (All European Academies), as well as of the advisory board of the German Reference Centre for Ethics in the Life Sciences.

Dr Anna David at UCL will also provide input having conducted a study with Richard Ashcroft, Professor of Bioethics and Law at Queen Mary University of London, on the ethical, legal and regulatory aspects of prenatal maternal gene therapy for severe early onset fetal growth restriction funded by EU FP7 (http://everrest-fp7.eu), which considered similar ethical issues. Dr David is also working with Professor Ashcroft to conduct an ethical, legal and regulatory evaluation about the development of innovative fetal imaging, therapy and surgery within the 7-year GIFT-Surg programme at UCL/KU Leuven (Guided Instrumentation for Fetal Therapy and Surgery funded by Wellcome Trust and EPSRC).

Regular multidisciplinary meetings with representatives from all fields involved including fetal medicine and OIspecialists, neonatologists, transplantation specialists and lay representatives will be used to discuss these ethical and psychosocial aspects.

This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement 681045

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