The University of Cambridge has launched a project to develop the first governance framework for research involving stem cell-based human embryo models in the UK.
The Governance of Stem Cell-Based Embryo Models (G-SCBEM) project is led by Cambridge Reproduction and brings together scientists, legal scholars and bioethics experts, as well as representatives from major funders and regulators of this research.
Stem cell-based embryo models (SCBEMs) are three-dimensional structures that mimic aspects of embryo development. They can be created from embryonic stem cells, which can be persuaded to form structures that share a number of features with the embryonic blastocyst stage – the stage at which, in conception, the embryo begins the process of implanting into the uterus.
SCBEMs may offer insight into these critical stages of early development – stages that are normally inaccessible to researchers. They also offer potential for understanding some of the problems that can affect early pregnancies and lead to miscarriage or birth defects. Given that one in four pregnancies is estimated to end in miscarriage, this research has the potential to transform treatments for recurrent miscarriage and to improve the success rates of IVF and other fertility treatments.
Research using human embryos in the UK is tightly regulated by the Human Fertilisation and Embryology Act, which prohibits scientists from culturing human embryos in the lab beyond 14 days. However, despite the resemblance to human blastocysts (the cluster of cells that forms about five days after an egg is fertilised), SCBEMS are not themselves embryos. They can be derived from embryonic stem cells but can only form in specific conditions within the laboratory. Because of this, they do not fall under the remit of the HFE Act.
Currently there is no dedicated regulatory framework addressing research using SCBEMs, although existing UK law does prohibit them from ever being transferred into a woman’s womb. Nonetheless, the absence of clear, transparent guidance in this area hinders research and risks damaging public confidence.
Cambridge Reproduction, working in partnership with the Progress Educational Trust (PET), aims to break this deadlock by producing a clear and comprehensive recommended governance framework for research using SCBEMs. As this is an emerging area of research, the team is consulting widely to determine the opportunities, areas of consensus and concerns posed by SCBEMs.
The consultation will also lay the groundwork for engaging the public and other stakeholders in a parallel two-way dialogue around the use of SCBEMs for research and in translation.
“This is a fast-developing area and the project will open important dialogues with researchers, funders, regulators and the general public,” said Professor Kathy Niakan, Chair of Cambridge Reproduction. “We hope that the resulting self-governance framework will enable scientists to proceed with their research with confidence, while maintaining public trust in this vital area of research.”
“Given the similarities that SCBEMs have with human embryos, they offer enormous potential to unlock secrets of early pregnancy,” said Professor Roger Sturmey from Hull York Medical School, Chair of the G-SCBEM Guidelines Working Group. “However, because of these similarities, it is important that scientists working in this field maintain high standards and public confidence and so we hope that a self-governance framework will provide this.”
Sandy Starr, Deputy Director of PET and a member of the G-SCBEM Oversight Group, said, “SCBEMs open up avenues of research that are vitally important for people affected by infertility or genetic conditions. Use of SCBEMs can advance our understanding of human development, disease and reproduction, improving established reproductive technologies while opening up new possibilities. For this research to thrive, it needs to be conducted responsibly and governed in a clear and transparent way, which is where the G-SCBEM project comes in.”
The G-SCBEM guidance will be launched in the late autumn, and will be regularly reviewed to ensure that it keeps pace with new scientific developments.
The G-SCBEM project is funded by grants from the BBSRC Impact Acceleration Account and the University of Cambridge Impact and Knowledge Exchange fund.
Image: Human stem cell embedded in a 3D matrix, Cryo SEM. Credit: Silvia Ferreira (Wellcome Collection)