Examination of the Immunological Behaviour of Human Embryonic Stem Cells in the Pancreas of Rats

In this research project, human embryonic stem cells are to be genetically modified by a retrovirus encoding a transgene expressing Green Fluorescent Protein. The stem cells will subsequently be injected into the pancreas of rat hosts in order to assess their survival, immunological activity and immunogenicity.

Because the embryonic stem cells are to be isolated without any intention of being used in humans, neither the Medicines and Healthcare products Regulatory Agency (MHRA) nor Human Tissue Authority (HTA) will be involved in regulating the research.  However, a licence from the Human Fertilisation and Embryology Authority (HFEA) is required as the project will involve the storage, manipulation and ultimate destruction of human blastocysts. In addition, Favourable Opinion from a Research Ethics Committee (REC) and approval of the local National Health Service Research and Development (NHS R&D) office are needed to generate the human embryonic stem cell line.

Once a human embryonic stem cell line has been established and as part of the HFEA conditions of its licence to the investigators, an application should be made to the Steering Committee of the UK Stem Cell Bank to deposit that line in the bank.  Before the cell line can be genetically modified with the retrovirus, a notification to the Health and Safety Executive (HSE) is required. Before the stem cells are introduced into the animal hosts and ahead of the immunological studies, approval of the Home Office Animal Licensing Inspectorate is required.

To see the Regulatory Route Map for this project, click on the route code M-91899. Alternatively, to see the Project View of the Regulatory Route, click on P-91899.