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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.
Research by the University of Huddersfield has helped shape policy and practice in the field of surgical site infection (SSI) and wound management. It has contributed to best practice guidance and helped to raise practitioner, industry and public awareness of the importance of effective clinical interventions in infection prevention, tissue viability and wound care. These efforts, recognised by numerous awards, have been supported by significant industry engagement and the successful development and use of on-line tools to share best practice, promote evidence-based care and highlight the value of an inter-disciplinary approach to the problem of SSI.
The work of Cardiff University's Wound Healing Research Unit revealed a need for, and led the development of, a disease-specific Health-related Quality of Life (QoL) instrument; the Cardiff Wound Impact Schedule (CWIS). CWIS is able to quantify in a psychometrically sound manner the impact of chronic non-healing wounds upon a patient's QoL. The tool, a first of its type, is accurate and sensitive to changes in the healing status of chronic wounds, particularly those of the lower limb. CWIS has been adopted internationally advantaging QoL assessments in both commercial and practice settings to yield economic and practice impacts as well as direct patient benefits.
Professor Andrew Webster's sociological research on developments in biomedical science has been impactful in shaping regulatory practice and influencing policy in relation to biobanking, stem cell research and regenerative medicine. In particular, his research has been used to: change donation procedures to the UK Biobank; influence regulatory decisions made by the UK Stem Cell Bank Steering Committee (UKSCBSC); contribute to regulatory practices associated with clinical trial design and adoption, and inform the UK government's investment strategy in regenerative medicine.
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.
Fundamental research on developmental biology of skin and skin appendages carried out by Prof Colin Jahoda's group has led to progress in the isolation of specific adult cell populations, understanding of their roles in skin and hair regeneration, and advances towards clinical applications. This has led to the development of new methods to replace human hair follicles, and has been the basis for multi-million dollar research and development projects by companies in the UK, the US and Japan. The Durham research has enabled Intercytex Ltd. to attract £27M in VC funding and £30M in an IPO in 2009, progressing to Phase IIa clinical trials. The US company Aderans Research Institute has spent $100 million in developing this "hair cloning" technology. A Durham University spinout company, ClarinnisBio, was also established in 2009, and has to date attracted ca. £1M in investment and has employed two scientists, in a region of the UK that suffers from relatively high levels of unemployment.
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.
Research at Swansea University on light therapy has contributed to an extensive market in laser and intense pulsed light (IPL) products for the therapeutic and cosmetic treatment of skin conditions. Impacts include: globally registered intellectual property; local manufacturing of a wide range of laser and IPL products; their distribution to over 40 countries; and resulting benefits to health in treating acne, rejuvenating skin and removing hair. The research undertaken by Swansea University and its companies pioneered this market in partnership with Procter & Gamble and Unilever; and established a joint venture with Sony UK to manufacture these laser and IPL products in South Wales. The Welsh government views this collaboration as an exemplar for the resurgence of UK specialist manufacturing.
Research at the UCL Institute of Child Health (ICH) has led to the successful treatment of children with primary immunodeficiency diseases for whom there was little chance of "cure" by the only other possible means: haematopoietic stem cell transplantation (HSCT). Beginning in 2002, we have treated 32 patients with four different primary immunodeficiency disorders. In total we have treated 12 patients with severe combined immunodeficiency (SCID-X1), 13 patients with adenosine deaminase deficient severe combined immunodeficiency (ADA-SCID), 5 patients with chronic granulomatous disease (CGD) and 2 patients with Wiskott-Aldrich syndrome (WAS). Most of the patients have been successfully treated and are at home, off all therapy. We are now starting to develop this technology to treat a wider range of related disorders.
Half of all burn injuries occur in children and around 10% of children who are burnt become infected by disease-causing bacteria that can increase the likelihood of scarring and in some cases cause death. Novel wound dressing prototypes have been developed using responsive smart sensing chemistry. These provide clinical solutions and commercial opportunities, have led to the founding of the charity Healing Foundation Children's Burns Research Centre with £1.5M of funding, have influenced the work of other charities and altered attitudes and practice in clinical paediatric burn treatment. The impact has been achieved by development of the novel chemistry in partnership with clinicians and practitioners, and through extensive engagement with health professionals, well beyond normal academic reach, parents and the wider public.