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We were the first to show that human stem cells could be used to create functional organ replacements in patients. These transplants, first performed to save the life of an adult in 2008, and then repeated to save a child in 2010, have changed the way the world views stem cell therapies. We have opened the door to a future where conventional transplantation, with all its technical, toxicity and ethical problems, can be replaced and increased in range by a family of customised organ replacements, populated by cells derived from autologous stem cells. This has altered worldview, changed clinical practice and had key influences on UK policy.
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.
Fundamental and applied research at RVC has led to introduction of stem cell therapy supporting equine tendon regeneration, advancing equine clinical practice internationally. A resultant spin-out company has delivered revenue-generating veterinary clinical services internationally and is now developing new human treatments. The therapy offers improved health and welfare, particularly in racing, as treated horses are less likely to re-injure in comparison with those managed conventionally, and consequently less likely to be culled due to premature termination of their competitive careers. The acceptance by the Medicines and Healthcare products Regulatory Agency that the equine treatment data provide validation for a phase II human clinical trial without further preclinical studies represents a rare and significant outcome for veterinary research.
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 developed 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 SHEF1 has been developed and approved for clinical trials for treating Age Related Macular Degeneration (AMD). Finally, Sheffield researchers have informed emerging regulatory guidelines about the safety of hESC regenerative medicine applications by authoring reports for government and research councils.
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.
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.
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.
A multidisciplinary team has worked in applied cell engineering implementing cell therapy and biological approaches in clinical practice since 1997. The team has two GMP accredited laboratories in hospital sites and a MHRA manufacturing license for chondrocytes and stromal /stem cells for delivery to patients in orthopaedic clinical trials. The research had impacts on health, economy, public policy and practitioners. Over 400 cartilage patients and over 150,000 knee ligament patients have benefited directly from the research, and associated turnover is over £40,000,000. Team members had influence on government, NICE and professional guidelines.
Novel biological scaffolds that regenerate with the patient's own cells have been researched, and patented and since 2008 developed, taken through successful clinical trials and commercialised. Economic impact within the REF period has been delivered through the University of Leeds spinout company Tissue Regenix plc, which has received £32M private investment, employs 35 people and is AIM listed, with a capital value of £70M. Health impact has been delivered through licensing and development by NHS Blood & Transplant Tissue Services. The biological scaffolds have demonstrated five years' successful clinical use in heart valve replacement and three years' clinical use as a commercial vascular patch.
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).