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:
Department of Health
Phone: 020 7210 5221
NDS.DH@coi.gsi.gov.uk