UK Stem Cell Bank Application for Phase IV Funding 2014 - 2017
Lead Research Organisation:
National Institute for Biological 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.
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.
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.
Organisations
- National Institute for Biological Standards and Control (Lead Research Organisation)
- Biotechnology and Biological Sciences Research Council (Co-funder)
- Leadscope Inc. (Collaboration)
- Cellectis (Collaboration)
- International Stem Cell Forum (ISCF) (Collaboration)
- National Institute of Health and Medical Research (INSERM) (Collaboration)
- Asymptote (Collaboration)
- Roslin Cells Ltd (Collaboration)
- Karolinska Institute (Collaboration)
- Agency for Science, Technology and Research (A*STAR) (Collaboration)
- Douglas Connect (Collaboration)
Publications
Stacey GN
(2014)
Putting cells to sleep for future science.
in Nature biotechnology
Geraghty RJ
(2014)
Guidelines for the use of cell lines in biomedical research.
in British journal of cancer
Isasi R
(2014)
Identifiability and privacy in pluripotent stem cell research.
in Cell stem cell
Stacey GN
(2014)
DNA profiling and characterization of animal cell lines.
in Methods in molecular biology (Clifton, N.J.)
Kurtz A
(2014)
Regulatory insight into the European human pluripotent stem cell registry.
in Stem cells and development
French A
(2015)
Enabling consistency in pluripotent stem cell-derived products for research and development and clinical applications through material standards.
in Stem cells translational medicine
Andrews PW
(2015)
Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI).
in Regenerative medicine
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
Heslop JA
(2015)
Concise review: workshop review: understanding and assessing the risks of stem cell-based therapies.
in Stem cells translational medicine
Barry J
(2015)
Setting Up a Haplobank: Issues and Solutions.
in Current stem cell reports
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 | Contribution to a national consultation/review |
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 | Contribution to a national consultation/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 | Public |
Country | United Kingdom |
Start | 04/2015 |
End | 09/2017 |
Description | MRC Capital bid |
Amount | £400,000 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 05/2014 |
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 | 09/2012 |
End | 10/2014 |
Description | TSB Regenerative medicine programme - Tools and technologies |
Amount | £75,000 (GBP) |
Organisation | Innovate UK |
Sector | Public |
Country | United Kingdom |
Start | 08/2012 |
Description | UK RMP |
Amount | £200,000 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
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 | 04/2013 |
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 | United Kingdom |
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 | Academic/University |
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 Ice Limited |
Description | |
Year Established | 1996 |
Impact | UKSCB carrying out qualification expts with stem cells |
Website | http://www.asymptote.co.uk |
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 | 2006,2007,2008,2009,2010,2011,2012,2013,2014 |
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 |