New toolkit for stem cell research and regulation

4 January 2010

A new UK Stem Cell Tool Kit has been launched as a reference tool for anyone developing programmes of human (but not animal) stem cell research and manufacture for clinical applications. The hope is that this portal will help streamline and accelerate the process of clinical translation from research into healthcare practice by making the regulatory path clearer for researchers within the stringent but facilitating regulatory framework for stem cell research’ in the UK.

For a given project, the Tool Kit offers graphical representations of regulatory routes, key regulatory questions and milestones, with detailed information about required steps and contacts for each stage.

The resource was developed by the Department of Health and the Medical Resaerch Council with the support of key regulatory bodies including the Gene Therapy Advisory Committee (GTAC), the Human Fertilisation and Embryology Authority (HFEA), the Human Tissue Authority (HTA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as other groups. It will be updated every three months.

Professor Brendon Noble of the MRC Centre for Regenerative Medicine in Edinburgh commented: “This will be an important tool in therapy development planning. It will also act as a focus for discussion over key issues and roadblocks to the development of cell based therapies” (see press release).

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