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Commercial Development of Stem Cells for Regenerative Medicine

Summary of the impact

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.

Submitting Institution

University of Sheffield

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology
Medical and Health Sciences: Ophthalmology and Optometry

Therapeutic application of skeletal stem cells for patient benefit

Summary of the impact

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.

Submitting Institution

University of Southampton

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology
Engineering: Biomedical Engineering
Medical and Health Sciences: Clinical Sciences

15: Opening up the opportunities for stem cell therapies for neurodegenerative diseases

Summary of the impact

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.

Submitting Institution

King's College London

Unit of Assessment

Psychology, Psychiatry and Neuroscience

Summary Impact Type

Health

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology
Technology: Medical Biotechnology
Medical and Health Sciences: Neurosciences

SOC02 - Emerging biomedical technologies: shaping practices and influencing policy

Summary of the impact

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.

Submitting Institution

University of York

Unit of Assessment

Sociology

Summary Impact Type

Societal

Research Subject Area(s)

Medical and Health Sciences: Public Health and Health Services

The Development of Stem Cells for Regenerative Medicine

Summary of the impact

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.

Submitting Institution

University of Sheffield

Unit of Assessment

Biological Sciences

Summary Impact Type

Health

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology
Technology: Medical Biotechnology

Health benefits, increased public awareness and changes in national policy result from the successful implantation of the first tissue-engineered trachea, created utilising the patient’s own stem cells

Summary of the impact

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.

Submitting Institution

University of Bristol

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology
Engineering: Biomedical Engineering
Medical and Health Sciences: Clinical Sciences

05_Patients’, policy-makers’, educators’ and the public’s understanding of stem cell research is increased through in-depth engagement.

Summary of the impact

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.

Submitting Institution

University of Edinburgh

Unit of Assessment

Biological Sciences

Summary Impact Type

Societal

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology

Development and transplant of human organs using nanocomposite materials

Summary of the impact

Researchers in UCL's Centre for Nanotechnology and Regenerative Medicine have pioneered a transformative therapy using their platform technology of next-generation nanocomposite biomaterials to create wholly synthetic human organs for transplant, including the world's first synthetic trachea, lacrimal (tear) ducts and bypass grafts. These products improve patient outcomes in situations where conventional therapies have not worked. Because the organs are functionalised with peptides and antibodies, as well as seeded with the patients' own stem cells, patients do not require immunosuppression. A university spinout company has been set up to commercialise the use of UCL's patented nanomaterial for cardiovascular devices as well as other organs.

Submitting Institution

University College London

Unit of Assessment

General Engineering

Summary Impact Type

Technological

Research Subject Area(s)

Chemical Sciences: Macromolecular and Materials Chemistry
Engineering: Biomedical Engineering
Medical and Health Sciences: Clinical Sciences

Treatment of patients with Hodgkin lymphoma not responding to conventional dose therapy

Summary of the impact

Clinical research from UCL established `salvage therapy' and autologous transplantation protocols for use in relapsed and resistant Hodgkin lymphoma and demonstrated the efficacy of such approaches. These treatments are now widely used standards of care. A reduced intensity transplant (RIT) regimen, incorporating alemtuzumab to reduce graft-versus-host disease, was also developed and a potent graft-versus-tumour effect was demonstrated. RIT treatments are now increasingly used in patients failing an autologous transplant and in those patients deemed to have a high risk of autograft failure, as determined by pre-transplant CT/PET scanning. We estimate that 5,000 patients have been cured in the REF period as a result of our research.

Submitting Institution

University College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Immunology, Oncology and Carcinogenesis

06_A portfolio of stem cell culture products is sold worldwide.

Summary of the impact

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).

Submitting Institution

University of Edinburgh

Unit of Assessment

Biological Sciences

Summary Impact Type

Technological

Research Subject Area(s)

Biological Sciences: Biochemistry and Cell Biology, Genetics

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