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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.
In 2008, Professors Martin Birchall and Anthony Hollander (University of Bristol) and a team of scientists and surgeons led from Bristol successfully created and then transplanted the first tissue-engineered trachea (windpipe), using the seriously ill patient's own stem cells. The bioengineered trachea immediately provided the patient with a normally functioning airway, thereby avoiding higher risk surgery or life-long immunosuppression. This sequence of events, which raised public interest and understanding around the world as a result of huge media coverage, acted as proof of concept for this kind of medical intervention. A new clinical technology with far-reaching implications for patients had passed a major test. This development demonstrated the potential of stem cell biology and regenerative medicine to eradicate disease as well as treat symptoms and has already led to the implantation of bioengineered tracheas in at least 14 other patients.
Between 2008 and 2011 researchers at the Department of Veterinary Medicine (DVM) undertook the first randomized double-blinded clinical trial of a cell therapy for spinal cord injury (SCI). The trial involved transplantation of autologous olfactory ensheathing cells into domestic dogs with chronic pelvic limb paraplegia as a consequence of clinical SCI. The results indicated a significant improvement in locomotor function. This study has had a major impact on 1) the public awareness of the use of veterinary disease in biomedical research, 2) public awareness of SCI and approaches to its treatment, and 3) current programmes, both veterinary and human, for SCI treatment.
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.
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).
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 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.
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.
Chronic myeloid leukaemia (CML) is a rare blood cancer, with around 560 new cases diagnosed in the UK each year. Research conducted by Professor Tessa Holyoake's team at the University of Glasgow has led drug development and stimulated clinical trials of therapies targeting CML stem cells at two major pharmaceutical companies (Novartis and Bristol-Myers Squibb). The researchers are listed as co-inventors of a novel compound (LDE225) and have promoted two further therapies targeting CML stem cells (BMS-833923 and hydroxychloroquine) into clinical trials as treatments for CML. Holyoake also had a key role in establishing the Paul O'Gorman Leukaemia Research Centre in May 2008, funded by more than 1,800 charitable donations totalling around £2.6 million and giving patients unprecedented access to the latest clinical trials.