UK Government

Department of Health: STEM CELL ROAD MAP TO MAKE RESEARCH EASIER

Press Release   •   Dec 15, 2009 10:48 GMT

New online toolkit will improve quality and speed of stem cell research

Stem cell researchers in the UK will, for the first time, benefit from a new online resource that will allow them to plan a regulatory route for their research, Minister for Public Health Gillian Merron said today.

The website known as the “UK Stem Cell Tool Kit”, will allow researchers to build a customised ‘map’ outlining all of the regulatory steps to take their ideas for a new treatment from the laboratory to patients.

Researchers will be asked seven key questions. Depending on their answers, a unique ’route’ generates on-screen, which provides them with all the regulatory requirements, information and points of contact within the relevant organisations to enable them to take their projects forward.

The Tool Kit can be accessed at www.sc-toolkit.ac.uk, and has been developed in response to calls from some UK stem cell researchers to clarify the regulatory requirements for research in the UK.

Minister for Public Health, Gillian Merron, said

“Stem cell research is a field that promises new and better treatments for many devastating conditions like Parkinson's Disease and Diabetes. Researchers wanted clearer guidance on regulation for research projects in the UK, so that is what the government have delivered.

"The launch of the UK Stem Cell Tool Kit will make it quicker and easier for researchers to identify the right regulation to allow them to explore new treatments for an NHS of the future".

The website has been developed by the Department of Health along with the Medical Research Council (MRC), Medicines and Healthcare products Regulatory Agency (MHRA), Gene Therapy Advisory Committee (GTAC), Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA), Health and Safety Executive (HSE), the Home Office and the UK Stem Cell Bank.

Welcoming the launch Dr Sandy Mather, Director of Regulation at the Human Tissue Authority (HTA), said:

"For the first time scientists have access to a single resource that will help them navigate regulation from the bench to the clinic.

“The Tool Kit demonstrates the commitment of regulators, government and funders to work together to help stem cell scientists in the UK translate basic stem cell research into clinical outcomes and commercial benefits.”

Professor Brendon Noble of the Medical Research Council (MRC) Centre for Regenerative Medicine in Edinburgh said:

“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

Notes to editors

  • The UK is at the forefront of stem cell research. As stem cell research moves from the laboratory and in to patients, we need to ensure that only the highest quality studies are performed on UK patients, both in terms of safety and ethics.
  • Over the past decade, the UK has developed a stringent but facilitating regulatory framework for stem cell research.  But because the science itself is highly complex and much is still unknown, each component of that regulatory system reflects the fact that the field is still developing. This has led some researchers to call for increased clarity on the regulatory system for UK stem cell research, especially for clinical studies.
  • The Department of Health sponsors many of the key regulators in this area, such as the Gene Therapy Advisory Committee (GTAC), Human Fertilisation and Embryology Agency (HFEA), Human Tissue Authority (HTA) and Medicines and Healthcare products Regulatory Authority (MHRA), we have led on the Project to provide clarification in an easily accessible and innovative format to the stem cell community.
  • Over the past year, the Department has worked with key UK regulators to produce a “interim regulatory route map” for stem cell research, a draft ‘paper’ version of which was released in March this year.  As an ongoing commitment to medical innovation, the Department is now delighted to launch the UK Stem Cell Toolkit which we hope encourages researchers to conduct their trials in our robust and all encompassing regulatory landscape in the UK.
  • For further details please contact the DH newsdesk on 020 7210 5221.
  • Contacts

    NDS Enquiries
    Phone: For enquiries please contact the above department
    ndsenquiries@coi.gsi.gov.uk