UK Stem Cell Bank - Third Phase

Lead Research Organisation: National Institute for Biological Standards and Control
Department Name: UNLISTED

Abstract

In 2002 the UK Government established that a Bank of human embryonic cell lines should be established to oversee the use of these cells to ensure that any cells of this type, used in the UK were obtained ethically and only used in research for the benefit of treatment of serious human disease.
In addition the Bank should provide access to quality-controlled stocks of these cell lines to provide a high quality international resource in support of the UK s stem cell community and to further the use of these cells in regenerative medicine. Such a role for the Bank in supporting the move of stem cell therapies from the laboratory to the bedside was confirmed to be a key element in the UK Stem Cell Initiative Report prepepared by Sir John Pattison and accepted by the Government.
In the next phase of funding (Phase III) the Bank aims to sustain and develop its position as the foremost repository of ethically-sourced and well characterised stocks of human stem cell lines banked to international quality standards. Whilst in Phase II the primary focus of the Bank was on academic research, Phase III will see the Bank coordinating more closely with scientific programmes translating research developments into therapeutic applications, the regenerative medicine clinical community and those developing human cell culture models to improve the efficiency of development of new drugs to reduce costs and increase patient safety. The Bank will continue to develop its international role in supporting the development of stem cell therapy through:
? the provision of quality-assured and safety tested cell lines and other products supporting researchers and clinical applications;
? its continued lead on best practice and the setting of international consensus standards for the delivery of high quality and safe stem cells;
? its developing training programme for stem cell scientists, technical staff and quality assurance personnel in support of the UK s developing regenerative medicine industry;
? its scientific collaborations and internal research programme to establish robust methodologies for cell expansion, differentiation, preservation and characterisation which will improve the qulity of materials supplied for research and provide improved methodological approaches for clincial application.
It is intended that the Bank will now implement its position as a national resource and international centre of expertise in support of the development of regenerative medicines and product safety in the UK.

Technical Summary

Following competitive tender to establish the UK Stem Cell Bank (the Bank) in 2002, and successful delivery of all objectives for Phase 1 funding (2003-2005), a Phase 2 grant for this project (2006-2011) was secured by the National Institute for Biological Standards and Control (now a centre of the Health Protection Agency). All objectives are again being met on time and within budgets agreed with sponsors. A description of progress made in Phase 2 is given in the attached Progress Report and in the Annual Reports on its website at www.ukstemcellbank.org.uk.

During Phase III, the Bank will focus its activities on supporting the key public health aspects of stem cell therapy and development of human cell-based assays in safety testing of products. Phase 3 will see the Bank coordinating more closely with translational scientific programmes, thus making the Bank?s resources available to provide broad support for the UK?s developing the regenerative medicine clinical community, both academic and commercial,and those developing models for in vitro toxicology and drug discovery. The Bank will work in closer coordination with commercial partners whilst retaining its neutral position and capability to support all stakeholders in this field.

At the same time, the Bank aims to sustain and develop its position as the foremost repository of ethically-sourced and well characterised stocks of human stem cell lines banked to international quality standards.

The Bank will continue to develop its international role in supporting the development of stem cell therapy through:

? the provision of quality-assured and safety tested cell lines and ancillary products;

? its continued lead on best practice and the setting of international consensus standards;

? its developing training programme for stem cell scientists, technical staff and quality assurance personnel;

? its scientific collaborations and internal research programme to establish robust methodologies for cell expansion, differentiation, preservation and characterisation.



Furthermore, the Bank proposes to implement its cost recovery plan to progressively reduce its dependence on Research Council funding during the period of Phase 3.



These aims are intended to sustain the leading International profile of the Bank whilst increasing its support for commercial delivery of products and at the same time progressing towards substantially removing the burden of funding which has fallen on its sponsors.

Publications

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