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Stembryos: Project launched to provide guidance on research using synthetic embryo models

This week a project was launched to develop the first governance framework for research involving stem cell-based embryo models (SCBEMs) (sometimes referred to as “stembryos”) in the UK.

The Governance of Stem Cell-Based Embryo Models (G-SCBEM) project is led by Cambridge Reproduction, part of the University of Cambridge, in partnership with the Progress Educational Trust (PET), an independent charity that improves choices for people affected by infertility.

Research involving human embryos is regulated by the HFEA in the UK. However, despite their similarities with the early stages of human embryos, SCBEMs are not embryos. SCBEMs are derived from stem cells and do not involve sperm or eggs cells. They can only form in specific laboratory conditions and could never develop into a human embryo. Consequently, they do not fall under the jurisdiction of the HFEA.

At present, there is no dedicated framework addressing research involving SCBEMs and clear, transparent, guidance is required to address this potentially revolutionary, emerging area of research.

The G-SCBEM project involves scientists, regulators, legal scholars, bioethicists and funders and aims to produce a clear and comprehensive recommended governance framework for research using SCBEMs. The first stage of the project is to establish areas of consensus and concern posed by SCBEMs through consultation. This is expected to be followed by engagement with the public and other stakeholders on the use of SCBEMs for research and in translation.

The G-SCBEM guidance will be launched in the late autumn, and will be regularly updated to ensure that it keeps pace with new scientific developments in this fast-moving field.

Julian Hitchcock, Of Counsel in Bristows Life Sciences Regulatory department, is a member of the G-SCBEM working party. You can read his thoughts on the governance challenges presented by stembryos and organoids of concern here.

“Human development models derived from stem cells have significant potential to advance therapeutic and diagnostic innovation. To have been invited to help develop a governance framework that will maintain public confidence in the research, development and use of stembryos is not only an honour, but indicative of the standing of Bristows as the leading UK practice working at the cutting edges of regulation and emerging science.” Julian Hitchcock, Of Counsel, Bristows LLP


embryos, stemcells, hfea, life sciences, life sciences regulatory