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Neural stem cells offer enormous therapeutic potential for stroke but they require regulatory approval. Researchers at King's College London (KCL) devised a technology to immortalise stem cells, generated clinical-grade neural stem cell lines and demonstrated efficacy in an animal model of stroke. KCL research underpins the first approvals in the UK for a therapeutic stem cell product. This led to an industry-sponsored clinical trial of a stem cell therapeutic that has demonstrated vital improvement in all the first five stroke patients treated. KCL research has made a significant impact by considerably reducing the timetable for delivering potential therapies which will affect the life sciences industry and the process now in place acts as a model for other technology developments in this area.
Impact on commerce: Five stem cell culture products derived from UoE research have been brought to a global market since 2009 through the US based company StemCells Inc. StemCells Inc strategically acquired Stem Cell Sciences plc (SCS), with its licensed portfolio of UoE patents, to position themselves as a world leader in cell-based medicine. This enabled them to develop media and reagent tools in order to pursue nearer-term commercial opportunities. These products include the gold standard media for embryonic stem cell culture, iSTEM.
Beneficiaries: Commercial companies and users of the stem cell culture products.
Significance and Reach: iSTEM is the gold standard media used worldwide by researchers for maintaining mouse ES cells in their basal, non-differentiated state. Products are sold worldwide through global life sciences companies.
Attribution: All research was carried out at UoE between 1994 and 2006 (published up to 2008), led by Prof Austin Smith. Collaboration with Prof Philip Cohen, University of Dundee, on one paper (2008).
Fundamental to effective treatment of diabetes is the understanding of complex mechanisms regulating the function and demise of insulin-secreting pancreatic beta-cells. Inherent limitations relating to pancreatic beta-cell supply coupled with short functional life in culture prompted the challenge to establish model clonal human beta-cells. Ulster exploited an innovative approach to first establish clonal rodent beta-cells. Further development of our novel technology resulted in the generation, patent protection, and commercialisation of world-first electrofusion-derived functional human beta-cells. Our unique and valuable beta-cell lines have been licensed to multi-national pharmaceutical companies for diabetes drug development and further commercialised by sales through ECACC (now Public Health England) to directly impact on both bio-industry and the international research community by providing a limitless supply of high quality model beta-cells for translational research and diabetes drug development.
Research on stem cells has led to an explosion of interest in the field of regenerative medicine, with the potential for new clinical interventions and treatments. Pioneering research in Sheffield led to the founding of a spin-out company, Axordia, in 2001, focussed on the applications of human embryonic stem cells (hESC) in medicine. Several hESC lines (including SHEF-1) were generated in Sheffield by Axordia, which was sold to Intercytex in 2008 for £1.68M. These Sheffield-derived hESC lines were then sold on to a major pharmaceutical company, Pfizer, for £0.75M in 2009. As a result, a clinical grade derivative of SHEF-1 has been developed and approved for clinical trials for treating age-related macular degeneration (AMD). In addition, Sheffield research has led to the licensing and sales of key hESC marker antibodies for stem-cell quality control. Finally, Sheffield researchers have informed emerging regulatory guidelines about the safety of hESC regenerative medicine applications by authoring reports and providing evidence to a Parliamentary committee. The case study has significant impact on commerce, health and welfare and public policy.
T lymphocytes recognise antigens in the form of an HLA-peptide complex. HLA-peptide tetramers consist of a fluorescent HLA protein and peptide which together bind to, and therefore identify, T cells that recognise this HLA-peptide complex. As such they have proven to be a revolutionary reagent in immunology. Professor Paul Moss at the University of Birmingham has played an integral role in the clinical and commercial application of tetramers, particularly around the cytomegalovirus (CMV)-specific immune response in the context of monitoring immune recovery after transplantation and pioneering a new approach for cellular immunotherapy. The impact of this research relates to the clinical management of CMV infection in immunosuppressed patients and the creation of Cell Medica, a UK Biotech company pioneering tetramer-based cell therapy, thus demonstrating impact on clinical practice and the UK economy.
Impact: Public engagement and education, influence on public ethical and scientific policy.
Significance: The first demonstration of cloning from an adult mammalian somatic cell has stimulated rolling religious, ethical, cultural, political and scientific debates. Dolly has become a scientific icon entering the public and educational lexicons in addition to scientific ones.
Beneficiaries: Human society, culture, education.
Attribution: Wilmut and colleagues (Roslin Institute, UoE), undertook somatic cell nuclear transfer and used it to perform the first successful cloning of an adult mammal.
Reach: Worldwide: Dolly became a scientific icon that is recognisable all around the world, representing a major public engagement with bioscience. For example; cloning principles are part of high school education including the International Baccalaureate (implemented in >3600 schools on five continents).
3D polyHIPE scaffold materials and synthetic retinoids developed at Durham University for applications in cell biology have been commercialized by Reinnervate, a Durham spin-out company, using a patent/licensing strategy. Reinnervate has raised £8m venture capital investment and has employed an average of 12 FTE staff since 2008, peaking at 27 in 2012. Polystyrene-based highly porous polyHIPE materials which act as 3D in vitro cell culture scaffolds were launched under the Alvetex® brand in November 2010 and a retinoid derivative, designed to control cellular development including stem cell differentiation down neural pathways, was launched as ec23®. The products have won several awards and Alvetex® was voted one of "The Scientist" magazine's top 10 Life Science Innovations of 2010.
Mouse disease models provide an invaluable tool to the medical sciences, underpinning the understanding of disease mechanisms and the development of therapeutic interventions. A new cultivation protocol for deriving mouse embryonic stem (ES) cells was developed by Dr Nichols between 2006 and 2009. This has facilitated the production of ES cells from disease model mice that can be manipulated in vitro and used to establish modified transgenic mice with the required genetic profile, in a single generation. This method reduces the number of mice needed, as well as associated costs and staff time, by 90%. Dr Nichols has trained industry delegates from international transgenics companies and transgenic facility managers in the new technology. As a consequence, a minimum of 26820 fewer mice have been used in experiments, and a minimum of £536k have been saved since 2009.
Seven patients with avascular necrosis of the femoral head and bone cysts have been treated successfully with skeletal stem cell therapy, developed by Southampton researchers, resulting in an improved quality of life. This unique multi-disciplinary approach linking nano-bioengineering and stem cell research could revolutionise treatment for the 4,000 patients requiring surgery each year in the UK and reduce a huge financial burden on the NHS. The work has been granted three patents and the team are in discussions on development of the next generation of orthopaedic implants with industry.
Impact on society, culture and creativity; health and welfare; practitioners: Extensive public engagement with a broad target audience has increased understanding of the hopes and hypes generated by stem cell research at UoE and elsewhere, and has provided resources for practitioners to deliver high-quality public engagement and science education.
Beneficiaries: Educators, teacher trainers, science communicators, journalists; patients; students; officials in the European Commission, the European Parliament and by extension constituents.
Significance and Reach: This programme has promoted informed decision-making among non-specialists and public acceptance of stem cell-based research and future therapies in Europe (compared for instance to the USA). The project is focused on Europe, but participation is world-wide. 767,000 unique visitors have accessed the www.eurostemcell.org website. The educational tools have been used by 11,000 pupils, and engaged 20,100 participants at festivals and science centres. More than 740,000 individuals world-wide have viewed the films (>240,000 confirmed online, film showings and DVD; estimated >500,000 TV audience).
Attribution: The programme reflects a range of stem cell research, substantially based on underpinning research carried out at UoE led by Professors Austin Smith and Ian Chambers. The outreach programme is led by Professor Clare Blackburn. Leadership, management, content identification, content format, editorial input, and evaluation of the outreach programme are all led at the University of Edinburgh.