UK Stem Cell Bank - Third Phase

Lead Research Organisation: Nat Inst for Bio 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

10 25 50
 
Description National Clinical hESC Forum
Geographic Reach Europe 
Policy Influence Type Membership of a guidance committee
Impact Providing best practice guidance for procurment of tissues, processing and testing for development of clinical grade hESC lines Interaction with HTA HFEA and MHRA has supported a UK proposal for a change in the EU Tissues and Cells Directive in 2012
 
Description hESCreg EC database as an EC tool to register ethically sourced hESC and hiPSC lines
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guideline committee
Impact Provided listing of international lines proposed for use in EC funded programmes This site is used by ECommssion to highlight hESC lines considered acceptable for use in EC funded research From 2014 registration on website is likely to be a prerequisite for use of lines in EC funded projects Project has been funded again from January 2016 for 5years
URL http://www.hescreg.eu/
 
Description Alternative testing cluster SEURAT-1 (Scr&Tox)
Amount £480,718 (GBP)
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2011 
End 12/2015
 
Description Alternative testing cluster SEURAT-1 (Toxbank)
Amount £251,697 (GBP)
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2011 
End 12/2016
 
Description EC FP7 ESNATS
Amount £126,000 (GBP)
Organisation European Commission 
Department Seventh Framework Programme (FP7)
Sector Public
Country European Union (EU)
Start 03/2008 
End 09/2013
 
Description International Stem Cell Forum
Amount £398,223 (GBP)
Organisation International Stem Cell Forum (ISCF) 
Sector Academic/University
Country Global
Start 03/2007 
End 07/2015
 
Description TSB Regenerative medicine programme - Tools and technologies
Amount £75,000 (GBP)
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 09/2012 
 
Description TSB Regenerative medicine programme - Tools and technologies
Amount £13,005 (GBP)
Funding ID 101105 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 10/2012 
End 10/2014
 
Description Tools
Amount £24,582 (GBP)
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 04/2010 
End 03/2011
 
Description hESCreg II
Amount £190,000 (GBP)
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 05/2013 
End 05/2015
 
Title Bank of 3T3 feeder cells for celltherapy 
Description Well documented source of 3T3 cells provided for use by skin engraftment andf limbal stem cell transplant groups in UK 
Type Of Material Cell line 
Year Produced 2006 
Provided To Others? Yes  
Impact Central source of qualified cells provided for UK health services at request of Department of Health Now under negotiation of agreements to permit International supply 
URL http://www.nibsc.org/uk_stem_cell_bank/cell_lines/mefs.aspx
 
Title MRC-5 feeder cells for cell therapy 
Description MRC-5 bank established in UKSCB cleanroom facilities 
Type Of Material Cell line 
Year Produced 2007 
Provided To Others? Yes  
Impact Cells with safe history of use inn vaccine manufacture made available to multiple groups for cell therapy development. 
 
Title QMEF service 
Description Preparation of mouse embryonic fibroblasts for use in culture of stem cell lines Marketed as QMEFs 
Type Of Material Technology assay or reagent 
Year Produced 2012 
Provided To Others? Yes  
Impact It provides reliable seed stocks of feeder cells for routine use in stem cell resarch which have been quaiified on a range of hESC lines 
URL http://www.ukstemcellbank.org.uk
 
Title human stem cell banks 
Description Banks of ethically sourced and quality controlled humna stem cell lines made available for public research and commercial development 
Type Of Material Cell line 
Year Produced 2006 
Provided To Others? Yes  
Impact Supporting research projects on stem cells for toxicology and and research in c80 other reserch organisations 
URL http://www.ukstemcellbank.org.uk
 
Description ESNATS 
Organisation TAP Biosystems
Country United Kingdom 
Sector Private 
PI Contribution Comparison and validation of different stem cell differentiation protocols to obtain different neuronal cell types
Collaborator Contribution Development of scale up and preservation protocols Development of differentiation protocols
Impact Publication : P DeSousa, S Mcrae and G Stacey Pluripotent stem cells as cellular product for regenerative medicine. In : Regenerative Medicine , In: Pluripotent Stem Cells and the Liver. Ed. D Hay , Science Publishers (2012 in press).
Start Year 2008
 
Description ESNATS 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Comparison and validation of different stem cell differentiation protocols to obtain different neuronal cell types
Collaborator Contribution Development of scale up and preservation protocols Development of differentiation protocols
Impact Publication : P DeSousa, S Mcrae and G Stacey Pluripotent stem cells as cellular product for regenerative medicine. In : Regenerative Medicine , In: Pluripotent Stem Cells and the Liver. Ed. D Hay , Science Publishers (2012 in press).
Start Year 2008
 
Description ESNATS 
Organisation University of Lausanne
Country Switzerland 
Sector Academic/University 
PI Contribution Comparison and validation of different stem cell differentiation protocols to obtain different neuronal cell types
Collaborator Contribution Development of scale up and preservation protocols Development of differentiation protocols
Impact Publication : P DeSousa, S Mcrae and G Stacey Pluripotent stem cells as cellular product for regenerative medicine. In : Regenerative Medicine , In: Pluripotent Stem Cells and the Liver. Ed. D Hay , Science Publishers (2012 in press).
Start Year 2008
 
Description International Stem Cell Banking Initiative 
Organisation International Stem Cell Forum (ISCF)
Department International Stem Cell Initiative
Country Global 
Sector Academic/University 
PI Contribution Led coordination of scientists and regulators from more than 20 countries and compiled reports and draft publications
Collaborator Contribution Consensus on best opractice (Andrews et al., Stem Cell Reports and Revs , Dec 2009). Stem cell bank self evaluation procedures (Stacey et al., Cell Stem Cell 2013). managing research data from stem cell lines (Isasi et al., Regen Med, 2012).
Impact Consensus on best practice in the procurement banking testing and release of hESC lines (2009) Andrews et al., (2015) Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications. Regenerative Medicine. 10 (02s) doi: 10.2217/RME.14.93 Stacey GN. (in press) Stem Cell Banking: A Global Overview. In: Stem Cell Banking: Methods and Protocols, Human Press, Springer Science +Business Media LLC, USA.
Start Year 2007
 
Description International Stem Cell Banking Initiative 
Organisation International Stem Cell Forum (ISCF)
Country Global 
Sector Academic/University 
PI Contribution Led coordination of scientists and regulators from more than 20 countries and compiled reports and draft publications
Collaborator Contribution Consensus on best opractice (Andrews et al., Stem Cell Reports and Revs , Dec 2009). Stem cell bank self evaluation procedures (Stacey et al., Cell Stem Cell 2013). managing research data from stem cell lines (Isasi et al., Regen Med, 2012).
Impact Consensus on best practice in the procurement banking testing and release of hESC lines (2009) Andrews et al., (2015) Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications. Regenerative Medicine. 10 (02s) doi: 10.2217/RME.14.93 Stacey GN. (in press) Stem Cell Banking: A Global Overview. In: Stem Cell Banking: Methods and Protocols, Human Press, Springer Science +Business Media LLC, USA.
Start Year 2007
 
Description International Stem Cell Initiative 
Organisation International Stem Cell Forum (ISCF)
Country Global 
Sector Academic/University 
PI Contribution Carried out characterisation testing, supplied stockc of antibodies, crried out independednt qualification of poor performing media
Collaborator Contribution three publications in In Vitro (2010) and Nature Biotech 2007 and in press
Impact Three publications in In Vitro (2010) and Nat Biotech (2007 and 2012) Stacey GN. (in press) Stem Cell Banking: A Global Overview. In: Stem Cell Banking: Methods and Protocols, Human Press, Springer Science +Business Media LLC, USA.
Start Year 2006
 
Description Scr&Tox 
Organisation Cellectis
Country France 
Sector Private 
PI Contribution Generation, banking and distribition of human pluripotent stem cell lines. Iisolation and distribution of iPSC lines as controls
Collaborator Contribution Development of differentiation protocols and translation into autmated HTP systems
Impact Publications on quality control ad assays development Pistollato, F., Bremer-Hoffmann, S., Healy, L., Young, L. and Stacey, G. (2012) Standardisation of pluripotent stem cell cultures for toxicity testing, Expert Opinion On Drug Metabolism and Toxicology, 8(2):239-257. Stacey GN, Coecke S, Price A, Healy L, Jennings P, Wilmes A, Pinset C, Sundstrom M. Myatt G. (2016) Ensuring the quality of stem cell derived models for toxicity testing. In: Validation of Alternative Methods for Toxicity Testing. Eds ESkes C and Whelan M. Springer. pp259-297.ISBN 978-3-319-33826-2
Start Year 2011
 
Description Scr&Tox 
Organisation National Institute of Health and Medical Research (INSERM)
Department Institute for Stem cell Therapy and Exploration of Monogenic diseases (I-Stem)
Country France 
Sector Public 
PI Contribution Generation, banking and distribition of human pluripotent stem cell lines. Iisolation and distribution of iPSC lines as controls
Collaborator Contribution Development of differentiation protocols and translation into autmated HTP systems
Impact Publications on quality control ad assays development Pistollato, F., Bremer-Hoffmann, S., Healy, L., Young, L. and Stacey, G. (2012) Standardisation of pluripotent stem cell cultures for toxicity testing, Expert Opinion On Drug Metabolism and Toxicology, 8(2):239-257. Stacey GN, Coecke S, Price A, Healy L, Jennings P, Wilmes A, Pinset C, Sundstrom M. Myatt G. (2016) Ensuring the quality of stem cell derived models for toxicity testing. In: Validation of Alternative Methods for Toxicity Testing. Eds ESkes C and Whelan M. Springer. pp259-297.ISBN 978-3-319-33826-2
Start Year 2011
 
Description TSB Apopro 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Provide expert opinion
Collaborator Contribution Development of product
Impact progress on prototype
Start Year 2012
 
Description TSB Asymptote 
Organisation Asymptote
Country United Kingdom 
Sector Private 
PI Contribution Development of new preservation equipment and preservation profiles
Collaborator Contribution Complimentary work within the research programme at Roslin Cells and coordination with the manufacturer (Asymptote) on improvements to software and hardware to effect enrichment of viable cells .
Impact Initial feedback on the new device Workplan established. UKSCB organised 2 coordination meetings between this project and other TSB funded projects in related areas Book chapter - Stacey, G., Healy, H., Mann, J., Hunt, CJ., and Morris, J. (2016) Fundamental Points to Consider in the Cryopreservation and Shipment of Cells for Human Application. Chapter 6. In: Bioprocessing for Cell- based Therapies. Ed. Che Connon, Wiley-Blackwell. pp167-186.
Start Year 2012
 
Description TSB Asymptote 
Organisation Roslin Cells Ltd
Country United Kingdom 
Sector Private 
PI Contribution Development of new preservation equipment and preservation profiles
Collaborator Contribution Complimentary work within the research programme at Roslin Cells and coordination with the manufacturer (Asymptote) on improvements to software and hardware to effect enrichment of viable cells .
Impact Initial feedback on the new device Workplan established. UKSCB organised 2 coordination meetings between this project and other TSB funded projects in related areas Book chapter - Stacey, G., Healy, H., Mann, J., Hunt, CJ., and Morris, J. (2016) Fundamental Points to Consider in the Cryopreservation and Shipment of Cells for Human Application. Chapter 6. In: Bioprocessing for Cell- based Therapies. Ed. Che Connon, Wiley-Blackwell. pp167-186.
Start Year 2012
 
Description ToxBank 
Organisation Douglas Connect
Country Switzerland 
Sector Private 
PI Contribution Creation of biomaterials sections of data warehouse for the multiconsotium cluster SEURAT-1
Collaborator Contribution Overall construction of data warehouse and toxciology sections
Impact Cross consotium collaboration on cell line quality control and poster preaetnations at SEURAT-1 meetings Kohonen, P; Benfenati, E; Bower, D; Ceder, R; Crump, M; Cross, K; Grafström, R; Healey, L; Helma, C; Jeliazkova, N; Jeliazkov, V; Maggioni, S; Miller, S; Myatt, G; Rautenberg, M; Stacey, G; Willighagen, E; Wiseman, J; Hardy, B (2013) The ToxBank Data Warehouse: Supporting the Replacement of In Vivo Repeated Dose Systemic Toxicity Testing. Molecular Informatics. Special Issue: Advances in Computational Toxicology. 32; 47-63. Public conference and workshop: Stem Cell Applications, Wellcome Trust, London, Nov 2015 Opentox workshop: Bridging strategies for stem cells, Rheinfelden, Germany, October 31st 2015.
Start Year 2011
 
Description ToxBank 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution Creation of biomaterials sections of data warehouse for the multiconsotium cluster SEURAT-1
Collaborator Contribution Overall construction of data warehouse and toxciology sections
Impact Cross consotium collaboration on cell line quality control and poster preaetnations at SEURAT-1 meetings Kohonen, P; Benfenati, E; Bower, D; Ceder, R; Crump, M; Cross, K; Grafström, R; Healey, L; Helma, C; Jeliazkova, N; Jeliazkov, V; Maggioni, S; Miller, S; Myatt, G; Rautenberg, M; Stacey, G; Willighagen, E; Wiseman, J; Hardy, B (2013) The ToxBank Data Warehouse: Supporting the Replacement of In Vivo Repeated Dose Systemic Toxicity Testing. Molecular Informatics. Special Issue: Advances in Computational Toxicology. 32; 47-63. Public conference and workshop: Stem Cell Applications, Wellcome Trust, London, Nov 2015 Opentox workshop: Bridging strategies for stem cells, Rheinfelden, Germany, October 31st 2015.
Start Year 2011
 
Description ToxBank 
Organisation Leadscope Inc.
Country United States 
Sector Private 
PI Contribution Creation of biomaterials sections of data warehouse for the multiconsotium cluster SEURAT-1
Collaborator Contribution Overall construction of data warehouse and toxciology sections
Impact Cross consotium collaboration on cell line quality control and poster preaetnations at SEURAT-1 meetings Kohonen, P; Benfenati, E; Bower, D; Ceder, R; Crump, M; Cross, K; Grafström, R; Healey, L; Helma, C; Jeliazkova, N; Jeliazkov, V; Maggioni, S; Miller, S; Myatt, G; Rautenberg, M; Stacey, G; Willighagen, E; Wiseman, J; Hardy, B (2013) The ToxBank Data Warehouse: Supporting the Replacement of In Vivo Repeated Dose Systemic Toxicity Testing. Molecular Informatics. Special Issue: Advances in Computational Toxicology. 32; 47-63. Public conference and workshop: Stem Cell Applications, Wellcome Trust, London, Nov 2015 Opentox workshop: Bridging strategies for stem cells, Rheinfelden, Germany, October 31st 2015.
Start Year 2011
 
Title Apopro 
Description Enrichment of viability in cell therapy products 
Type Support Tool - For Medical Intervention
Current Stage Of Development Initial development
Year Development Stage Completed 2012
Development Status Under active development/distribution
Impact Early devt yet to have impact 
 
Title Asymptote 
Description Novel preservation equipment for clean rooms 
Type Support Tool - For Medical Intervention
Current Stage Of Development Initial development
Year Development Stage Completed 2012
Development Status Under active development/distribution
Impact Early development none as yet 
 
Company Name Apropo 
Description Developing equipment to optimise preservation and viability of cell therapy products 
Year Established 2012 
Impact UKSCB supported on evaluation of equiment utility
Website http://www.companieslist.co.uk/SC421400-coolgenics-limited
 
Company Name Asymptote 
Description Developing novel cryopreservation devices 
Impact UKSCB carrying out qualification expts with stem cells
Website http://www.cambridgenetwork.co.uk/directories/companies/2486/?atoz=A
 
Description Edinburgh stem cell public awareness day 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact c50 attendees at an open public meeting to discuss stem cell research and the role of UKSCB

No further action
Year(s) Of Engagement Activity 2011
 
Description Presentations at scientific meetings 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Presentations more numerous than can be listed here. c30-50 presetnations per year at various scientific meetings including International Society for Stem Cell Reseaerch, UK Nat Stem Cell Network, MRC and BBSRC grant holders meetings, commercial conferences. Summaries given in Annual Reports available of UKSCB website

Ongoing invitations to attend scientific meetings
Year(s) Of Engagement Activity 2006,2007,2008,2009,2010
 
Description UKSCB Open Forum 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact c50-100 attendees at UK National Stem Cell Network sessions run by UKSCB latterly run as a technical forum to engage researchers in the hESC and iPSC field

New contacts re potential UKSCB users
Year(s) Of Engagement Activity 2009,2010,2013,2014