Question to the Department of Health and Social Care:

To ask Her Majesty’s Government under what circumstances embryonic stem cell lines that have been derived from human embryos subjected to genome editing by means of CRISPR-Cas9 would be considered to conform to good manufacturing practice and classed as clinical grade by either the Human Fertilisation and Embryology Authority or the UK Stem Cell Bank.

The Human Fertilisation and Embryology Authority (HFEA) has advised that it has licensed one human embryo research project involving the use of genome editing CRISPR-Cas9. One objective of this project is to derive human embryonic stem cells. As outlined in the HFEA Inspection Report, there is no intention for these stem cells to be used in human application. In these circumstances, there is no need to assess whether they conform to good manufacturing practice and are classed as clinical grade.