Scope of the Tool Kit

The Tool Kit is intended to be a reference tool for those who wish to develop a programme of stem cell research and manufacture, ultimately leading to clinical application. The Tool Kit applies only to the regulation of human stem cells and their use in the laboratory and clinical settings. It does not cover the use of animal stem cells in non-clinical settings. In general, it will not be possible to determine with any degree of certainty the exact regulatory route for a given application without first consulting directly with the appropriate regulatory bodies.

Maps generated using this Tool Kit start from the point at which a decision has been made to generate de novo stem cell material. Some stem cell applications will, of course, be developed from pre-existing sources of stem cells. This might be the case, for example, with a project which began with obtaining of an embryonic stem cell line from the UK Stem Cell Bank. In such a case, the regulatory route for that particular research programme would commence from that point of procurement onwards on the map.