UK Stem Cell Bank Application for Phase IV Funding 2014 - 2017

Lead Research Organisation: Nat Inst for Bio Standards and Control
Department Name: Cell Biology and Imaging

Abstract

Our growing understanding of the biology of human pluripotent stem cells (hPSCs) provides unprecedented opportunities to generate cells to repair or replace any cell-type for large numbers of patients with traumatic injury, genetic defects and degenerative diseases. It also provides researchers with a powerful research tool to develop human tissue models to study human disease, develop new drugs and investigate their safety. The pathway to deliver these advances in basic science and medicine in an efficient and robust way is to establish a solid structure that starts with ethically sourced, reliable and appropriately characterised source materials (cells and controls). It also requires methodologies to enable key scientific and medical developments to feed a pipeline for new medical products and novel applications of stem cells. A key function of UKSCB in the UK regenerative medicine programme will be to make available carefully prepared and tested stocks of ethically sourced human stem cell lines, produced in the UK specifically for clinical use. The UKSCB will prepare these as a centralised UK resource of well characterised human embryonic stem cell (hESC) banks for cell therapy (i.e. compliant with UK and European regulation) and make them available to the UK and international cell therapy community. Stem cell lines with a range of genetic and physical characteristics of value to researchers will also be banked and made available by UKSCB to the international research community. This banking programme will also support the research community by releasing stocks of its own feeder cells to use in routine stem cell culture. The UKSCB will also deliver a translational research programme focused on 1) improving banking processes and 2) standardisation and safety issues for clinical use of stem cell cultures. The first theme in UKSCB research will enhance its cell banking function through i) optimisation of methods for culture expansion, characterisation and cryopreservation of stem cell lines, and ii) generation of new human feeder cells for culture of clinical grade stem cells lines. In the second theme on standardisation and safety, UKSCB will use cutting edge genome sequencing techniques to develop screening methods for microbial agents and mutations in clinical grade cells and also develop methods and control materials to assist in establishing metrics for reproducibility and acceptability of stem cell cultures for use. The research planned under core MRC funding for the UKSCB will be supported by existing collaborations with additional funding and will be expanded significantly (particularly in automation and improving stem cell characterisation) through new grant applications currently under evaluation. Other work will include an active programme of training, education and advice based on the UKSCB's experience and expertise in stem cell culture, preservation, characterisation and regulatory issues. This will be developed with supplementary funding obtained through collaboration with other stem cell banks and stem cell research institutes in the UK and abroad. The UKSCB international profile will be maintained and developed through active engagement with researchers and stem cell banks in other countries and its leadership in stem cell banking and regulatory science issues for cell therapy. This will be used to facilitate links between foreign laboratories and companies and the UK regenerative medicine community to promote collaboration and inward investment. In conclusion, the UKSCB proposal will provide fundamental component of UK regulation on the use of embryos which has gained the UK a reputation for solid and robust ethical regulation. In addition, it will ensure there is vital underpinning support on technical, safety and ethical issues that is critical for the early stages of translation of research methods into 'first in man' studies to assure a safe and secure pathway to new cell therapies.

Technical Summary

The Bank will work closely with UK derivation centres to procure hESC lines, assure their compliance with UK and EU regulation and produce a panel of well characterised hESC banks and feeder cells for use in humans (i.e. EUTCD-hESCs). In addition, the Bank will continue to develop its panel of research grade hPSCs, focussing on those with greatest value in research, including a set of reference cell banks (RCBs) of hESC and hiPSCs. The process of banking will be streamlined and flexibility increased by the automation of aspects of banking and characterisation. The Bank will generate quality controlled, safety-tested human diploid fibroblasts as starting materials for a reference panel of hiPSCs to be developed by the Bank using a range of reprogramming methodologies.
RCBs and EUTCD-hESCs will be subjected to investigation of their genomic and phenotypic characteristics, stability on extended passage and microbiological safety. Data will be published on the Bank's website and other research databases to enhance the value of these cell lines to researchers and provide important information on the suitability of EUTCD-hESCs for clinical use. The Bank will also develop generic regulatory science approaches and control materials for standardisation of hPSCs for use in establishing cell therapies. Its R&D will be coordinated with leading researchers and NIBSC scientists in a programme of research projects funded from a variety of sources. It will maintain an active programme of training and advice for industry and research. In summary the UKSCB Phase IV proposal provides a well-rounded programme of supply of important research materials, well-characterised and qualified starting materials for development of cell therapies, underpinning method development for application in hPSC-based medicines and a training, advisory and external coordination programme to facilitate the development of the UK regenerative medicine and promote robust and high quality stem cell research.

Planned Impact

The beneficiaries of the UKSCB's focus on banking of Clinical Grade hESCs and underpinning research in regulatory science of stem cells will be both the clinical and industrial research communities. They will benefit from the quality-controlled Laboratory Grade cell lines (thus avoiding the serious risk of contaminated or misidentified cell lines) as well as the safety-tested EUTCD-Grade cell lines suitable for clinical trial, where availability of traceable, well documented, reliable and appropriately qualified stocks of cells will be paramount from a regulatory and patient health perspective.
The UKSCB already has strong links with commercial organisations such as GSK, Roslin Cells, Asymptote, Apopro, and GE Healthcare through existing and proposed research collaborations. Other strong links have evolved with suppliers such as TAP, Stem Cell Technologies and LifeTechnologies through beta testing of new technologies, where the Bank's expertise in a broad range of hPSCs, and its recognised ability to troubleshoot and investigate the suitability of raw materials from a risk and quality perspective, continues to be important to reagent and media suppliers.
The Bank and NIBSC also provides expert advice in the field of regenerative medicine to regulatory bodies (e.g. MHRA, EMA, USFDA and WHO), UK and US funding bodies and policy setting groups (e.g. UK DH, Japanese and Korean authorities), charities (e.g. AMRC), patient lobby groups, and the media.
In addition the UKSCB is actively engaged with key UK government funded organisations (e.g. Cell Therapy Catapult Centre, NHSBT, UK Biobank) and many of the UK stem cell centres, including Stem Cell Institute (University of Cambridge), HiPSC (Sanger Institute), and the Centre for Stem Cell Biology (University of Sheffield), in helping to consolidate the UK infrastructure in support of regenerative medicine. It also provides expertise to the regional networks (e.g. Manchester Tissue Regeneration and Stem Cell Network, Regener8) and other research consortia in the UK (e.g. UKRMP hubs, Stem Cells for Safer Medicine). Within Europe the Bank also impacts on research, through its involvement in EU framework 7 consortia such as ESNATS, Scr&Tox, Seurat-1, StemBANCC, ToxBank and ISCF funded ISCI.
The UKSCB, through its participation in, or leadership of, both UK (e.g. National Clinical human Embryonic Stem Cell Forum) and international (e.g. International Stem Cell Banking Initiative) forums provides regulatory and scientific expertise to more than 20 countries on best practice in the culture, characterisation and banking of stem cells for both research and clinical application. The UKSCB's strong international networking also provides a current and growing benefit to members of the UK regenerative medicine community through introductions to foreign researchers and companies with potential benefits of collaboration and inward investment.
The UKSCB's role in providing advice and practical training, through for example its joint course with the Harvard Stem Cell Institute, will benefit new researchers in the stem cell and regenerative medicines field; providing them with the crucial scientific and technical knowledge in the use of stem cell lines. This will have an ongoing, and potentially growing, impact as new fields of research begin to use stem cell lines in their research. Those academics, clinicians and industrial partners working at the early translational phase between basic research and clinical implementation can obtain immediate and valuable benefit from the UKSCB's technical knowledge (built over ten years), its independent and neutral advice on regulatory issues and its capabilities in regulatory science. This will facilitate the avoidance of critical problems and help smooth the path to safe and effective cell-based medicines over the next ten years and beyond for both hESC-derived cellular therapies and the nascent field of hiPSCs.

Publications

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Barry J (2015) Setting Up a Haplobank: Issues and Solutions. in Current stem cell reports

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Geraghty RJ (2014) Guidelines for the use of cell lines in biomedical research. in British journal of cancer

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Hayakawa T (2015) Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products. in Biologicals : journal of the International Association of Biological Standardization

 
Title EBiSC training videos 
Description Training videos for the EBiSC project consortium in the culture and preservation of HPSCs 
Type Of Art Artefact (including digital) 
Year Produced 2016 
Impact Widespread training resource used to train scientific staff employed on the EBiSC banking project 
URL http://www.ebisc.org
 
Title Toxbank U Tube videos 
Description Video on cell culture best practice on UTube 
Type Of Art Film/Video/Animation 
Year Produced 2014 
Impact To be used in Dec 2014 training course 
URL https://www.youtube.com/results?search_query=Stacey+good+cell+culture+practice
 
Guideline Title SaBTO guidance on selection donor tissues used in cell-based medicines
Description Contribution to SaBTO standing advisory committee activity
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
Impact Clearer guidance on risk assessment and testing for cell-based medicines for manufacturers and regulators
URL https://www.gov.uk/government/publications/donation-of-starting-material-for-advanced-cell-based-the...
 
Description ISCBI Workshops on best practice for supply of hPSCs for clinical use
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www.stem-cell-forum.net/initiatives/international-stem-cell-banking-initiative/
 
Description National Forum for hESC derivatioa centrs and product developers
Geographic Reach National 
Policy Influence Type Participation in a national consultation
Impact Forming expert consensus on effective and safe delivery of pluripotent stem cells for therapy
 
Description RMEG DH committee
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact A number of initiatives taken forward to simplify regulation and improved advice to industry including one-stop-shop for regulatory advice on regenerative medicines
URL https://www.gov.uk/government/groups/regenerative-medicine-expert-group
 
Description Response to Paliamentary Questions
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Workshop on Genetic Data
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Providing guidance on best practice - consensus report has been released and will be placed on UKSCB website
URL http://www.nibsc.org/science_and_research/advanced_therapies/uk_stem_cell_bank.aspx
 
Description Workshop on the impact of new EU regualtion on patitnet data protection (Department of Health)
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Meeting of expert groups engaged in storage of patient data including Sanger, 1000 genomes project, Nuffield Council, Wellcome Trust, MRC, cell lines collections (ECACC, EBiSC) . Addressed needs to begin to accommodate changes in EU regulations and agree best practice.
 
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)
Funding ID 266753 
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)
Funding ID 267042 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2011 
End 12/2016
 
Description EBiSC - European Commission Innovative Medicines Initiative
Amount € 2,600,000 (EUR)
Funding ID 115582 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2014 
End 01/2017
 
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 MICA Industrial Collaboration (MRC)
Amount £1,281,466 (GBP)
Funding ID MR/M017354/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 05/2015 
End 09/2017
 
Description MRC Capital bid
Amount £400,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 06/2014 
End 03/2015
 
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 TSB Regenerative medicine programme - Tools and technologies
Amount £75,000 (GBP)
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 09/2012 
 
Description UK RMP
Amount £200,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 02/2014 
End 02/2016
 
Description hESCreg II
Amount £190,000 (GBP)
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 05/2013 
End 05/2015
 
Description hPSCreg III (2016-2020)
Amount € 1,000,000 (EUR)
Organisation European Union 
Sector Public
Country European Union (EU)
Start 01/2016 
End 12/2020
 
Title Control for HESC flow cytometry 
Description Cell lines for flow cytometric controls for characterisation of cell markers for hPSCs NIBSC8 selected as candidate for development of reference materials cryopreserved and fixed cell preparations under evaluation 
Type Of Material Cell line 
Year Produced 2016 
Provided To Others? Yes  
Impact Enhanced quality control of hPSCs through the provision of both positive and negative controls for the standard panel of intracellular and surface markers of "stemness" 
 
Title MICA standard hESC cell bank 
Description Central stock of well characterised H9 hESCs for use by partners in the MICA TEE project 
Type Of Material Cell line 
Year Produced 2015 
Provided To Others? Yes  
Impact Enhanced standardisation across the investigation by the project partners through provision of cells from the central stock 
 
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 Refrence material for enumeration of mesenchymal stromal cells i flow cytometry 
Description The NIBSC8 cell line has been differentiated to create derivative cells of mesenchymal stromal cell phenotype for use as controls for flow cytometry in a collaboration between UKSCB staff and the Division of Biotherapeutics at NIBSC. A 100 vial stock has been prepared for a preliminary collaborative study to evaluate its value 
Type Of Material Biological samples 
Provided To Others? No  
Impact The field of MSC research and therapy is conflicted by variable reporting of the properties of MSCs. Controls for their characterisation could benefit the science in the field and patient safety 
 
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
 
Title p3 QMef Service 
Description Provision of additional materials under the QMEFs service - passage 3 cells for use as a feeder layer for the culture of hPSCs. This represents a more convenient format for users. 
Type Of Material Cell line 
Provided To Others? No  
Impact None yet - service launching in summer 2016 
 
Description Astar 
Organisation Agency for Science, Technology and Research (A*STAR)
Country Singapore 
Sector Public 
PI Contribution Support the development of hIPSC banks for human application
Collaborator Contribution Provision of cell differentiation protocols and funding
Impact No so far - early planning meetings only
Start Year 2016
 
Description EBiSC 
Organisation Roslin Cells Ltd
Country United Kingdom 
Sector Private 
PI Contribution Lead workpackages on quality control/characterisation and training and member of Project Board Research team provide support with two three new posts recruited to carry out work
Collaborator Contribution The collaboration will establish a new European stem cell supply centre for hiPSC lines. There are 33 partners from industry (SMEs and big Pharma) academia and government laboratories. Selected partners provide cell lines to initiate the collection or establish the procedures and a new banking and supply facility.
Impact None at this time one publication in press
Start Year 2014
 
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 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 NIBSC8 iPSC line licensed non-exclusively to industry 
Description The NIBSC8 cell lines was established in a EC funded UK Stem Cell Bank IV project collaboration ad is the subject of a current licensing agreement now close to conclusion. 
IP Reference  
Protection Protection not required
Year Protection Granted
Licensed Commercial In Confidence
Impact Development of a "mini-brains" research toll for toxicology
 
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 
 
Title Banking of EUTCD Grade cell lines for use in clinical trials 
Description Completion and release of the first EUTCD grade cell lines suitable for use in clinical trials MShef-2, -7 and -10 released February 2017 
Type Therapeutic Intervention - Cellular and gene therapies
Current Stage Of Development Initial development
Year Development Stage Completed 2017
Development Status Under active development/distribution
Impact Interaction of UKSCB with key developers of hPSC derived products for clinical trials 
 
Title Production testing of simulated EUTCD cell line 
Description The production of a Clinical grade seed stock of hESCs require validation under the HTA license. The first laboratory grade variant of an cell line suitable for clinical application (MShef2) has been prepared and will be released in summer 2016. Banking of the Clinical variant MasterShef 2 will commence in April 2016. 
Type Therapeutic Intervention - Cellular and gene therapies
Current Stage Of Development Initial development
Year Development Stage Completed 2015
Development Status Under active development/distribution
Impact The development process has confirmed to the regulator that the UKSCB can generate consistent cell lines for human application under compliance with regulatory requirements 
 
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 Hertfordshire schools presentations 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Schools
Results and Impact Approximately 50 A level students at each presentation

Repeated request to return and speak as covers an area of the national curriculum in which teachers felt external support would be helpful
Request to speak to a larger coordinated meeting for Herts schools in 2013
Year(s) Of Engagement Activity 2010,2011,2012,2013,2014
 
Description Intreational cell therpy workshop (IABS) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact A international workshop which brought regulators ad industry together with academia. Attracting 18 countries including 6 regulators
Year(s) Of Engagement Activity 2016
URL http://www.ibs.org
 
Description Pluripotent Stem Cell Platform-Pluristem workshop on manufacture of pluripotent stem cells and mesenchymal stromal cells 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Coordination of the UK RMP hub, the Pluripotent Stem Cell Platform, and the EC funded project PluriMes. Expert speakers and audience member discussed various issues in the stable expansion, manufacture ad testing of stem cell therapies. A re[port is in preparation for publication
Year(s) Of Engagement Activity 2016
 
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 Toxbank stakeholders workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Public and stakeholder Workshop around data management in the field of toxicology and European initiatives supporting the development of stem cell based in vitro models
Year(s) Of Engagement Activity 2015
 
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
 
Description UKSCB Techical Forum workshop, Gene editing of iPSC lines (NIBSC) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Workshop to discuss technical challenges in gene editing cell lies
Year(s) Of Engagement Activity 2016
 
Description UKSCB Technical Forum meeting, Stem Cell Culture (UCL) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact A meeting to discuss a arrange of technical issues related to the culture of stem cells. Held at University College London
Year(s) Of Engagement Activity 2016