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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.
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.
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.
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.
The University of Nottingham's School of Chemistry has developed a novel method of incorporating thermally or chemically labile biologically active substances into polymers. This has been achieved by using supercritical carbon dioxide as a medium for the synthesis and modification of polymeric materials. The method has been employed as the basis for new drug-delivery devices whose viability in the healthcare sphere has been confirmed by patient trials. The spin-out company, Critical Pharmaceuticals Ltd, has delivered a range of economic benefits, including job creation, the securing of millions of pounds' worth of investment and a number of revenue-generating research collaborations.
Nanoforce Technology Ltd. is a spin-out company wholly owned by QMUL, active in the field of polymeric and ceramic materials. Bridging the gap between academic research and industrial applications, Nanoforce has done business with over 100 companies since 2008, providing the key research expertise and specialist facilities to enable the development of new materials and commercial products, including Sugru® a room temperature vulcanizing silicone rubber, Zelfo® a self-binding cellulose material, and BiotexTM a range of high-performance yarns, fabrics and pre- consolidated sheets based renewable resources such as PLA and natural flax fibres. Nanoforce has been promoting the development and commercialisation of spark plasma sintering (SPS) since 2006, which resulted in Kennametal recently opening the first commercial SPS facility in the UK to produce advanced ceramic armour. Nanoforce's clients have included large multi-nationals such as DSM, Dow Chemical, General Electric, SABIC, L'Oreal, Shell, Sibelco, governmental agencies such as Defence Science and Technology Laboratory (Dstl), and a large number of SME's.
A manufacturing process developed by Bradford researchers has revolutionised the way endodontists perform root canal treatments. When coated with a hydrophilic polymer, the highly-filled hygroscopic material has enabled UK company DRFP to develop SmartPoint — a new endodontic technique that dramatically reduces failure rates of root canal treatments from 11-30% over five years to approximately 1%, and gives lower levels of post-operative pain when compared with conventional techniques. The technology has won three awards for innovation and DRFP has expanded significantly, with a dedicated production facility and sales team offering visits to dentists to demonstrate the benefits of the technology.
UCL's creation of ultra scale-down (USD) technologies has led to economic benefits by speeding to manufacture next-generation healthcare products. This has resulted in documented savings for pharmaceutical companies in pilot-scale studies (eg ~£280k for a protein therapy) and in manufacturing cost-of-goods (eg ~£200k pa for an antibody). Licensing values realised for USD-facilitated manufacturing processes range from a £10m early-stage payment for an antibody therapy [text removed for publication] to US$1bn for a therapeutic vaccine.
Since 2008 some 40 companies have used UCL USD technologies, which have now also facilitated the formation of a spin-out company and additional job creation. Patient benefits have emerged through the contribution of USD to better bioprocess definition, with USD technologies now helping deliver the US Food and Drug Administration's Quality by Design initiative for biopharmaceuticals, valued at more than US$20bn a year through a 25% reduction in time-to-market and more robust manufacture.
Prof Silver's research on the development of the technology to fabricate 3D electro-optic circuits via ink-jet and screen printing has provided a more sustainable solution to conventional back-lit posters (energy saving up to 75%) and printed displays. Due to the flexibility of the components (they can be printed in any shape or design) and low maintenance (battery operational), the technology has been commercially exploited by several industrial collaborators. Johnson Matthey have used Brunel research to gain knowledge of the market and supply chain, to sell silver and palladium nano-particles for ink-jet printing and to inform the investment of around £2M on R&D in this area. Intrinsiq Materials Ltd successfully marketed copper-based inks for ink-jet printing of ACEL displays, allowing the company to employ 22 additional staff. In addition, they have secured $4M of venture capital investment to develop the technology. Printed Electronics Ltd have secured £8.6M of investment to develop a high-volume supply chain for printed electronics, and have employed an additional 9 staff within the company. As a result of working with Brunel, Keeling and Walker have begun to sell ink that contains antimony-doped tin oxide nano-powders.