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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.
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.
Multi-disciplinary research at Leeds has led to a step change for treatment of early tooth decay using a minimally invasive regenerative therapy, eliminating the need for surgical excavation ("Filling without Drilling"). The patented technology was licensed to a spin-out company (Credentis ag), completed "first in man" trials at Leeds [6] and received a CE-label for clinical use in Switzerland, Europe and Canada. The trials demonstrated clinical efficacy that is safe and favoured by patients. Two new products are now on the market. Credentis were recognised as one of the top start ups in Switzerland [A], won the Swiss Technology Award in 2013, have established a new UK base and have engaged a UK company as suppliers, creating new business for a UK owned industry.
A new class of synthetic self-assembling peptides has been developed at Leeds into a product that allows the enamel in the dental cavities to be regenerated. The peptides assemble to form gels that have been shown to be promising biocompatible materials with applications in regenerative medicine, for example in the regeneration of bone. Credentis AG (Switzerland) was founded in January 2010 to commercialise the technology in the dental care domain. Its first product Curodont™ Repair - the first product of its kind in dental care - has completed first-in-man safety trials (also at Leeds); has received regulatory approval for clinical use in Switzerland, Europe and Australia; and was launched in Switzerland and Germany in Q1/2013. The product has tremendous promise because most adults suffer from dental caries which often go untreated because of patients' fear of the dental drill. A second product Curodont™ Protect, approved in April 2013 and regulated as a cosmetic, has been launched in 2013 for the treatment of dentin hypersensitivity. Credentis has established a UK base in Leeds and has engaged a UK company as distributor of its products from October 2013.
Professor Stephen Russell's fundamental and applied research on the formation, structure and properties of nonwoven fabrics has directly led to the creation and continued success of the Nonwovens Innovation and Research Institute (NIRI) Ltd a University of Leeds spin-out company. Formed in 2005 to exploit Russell's research, NIRI has grown annual sales revenue to ~£1 million supplying products and services that have enabled many medium-sized enterprises (SMEs) and global public limited companies (PLCs) to launch improved or new products, growing their market share and positively impacting consumers. Additionally, the research has enabled NIRI to independently establish and co-fund new commercial joint ventures that have resulted in the development of new IP (intellectual property)-protected products for improving global health and security. NIRI has grown its workforce to twenty (mainly University graduates) and has been profitable from the first year of trading.
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.
Microsulis Medical Ltd was founded in 1997 by the University of Bath to commercialise Professor Nigel Cronin's invention of a device for microwave endometrial ablation (MEA) for use in treating excessive menstrual bleeding (menorrhagia). This minimally invasive therapy has a success rate exceeding 80% and remarkably short treatment and recuperation times. It has been used to treat over 20,000 patients worldwide since 2008. In Feb 2011 Microsulis sold the rights to its MEA device for $3m to a US company in order to concentrate on another application of Cronin's microwave technology, namely microwave tissue ablation (MTA) for use in treating cancer. Microsulis MTA systems are in place in over 100 hospitals worldwide and have been used in over 5000 treatments of tumours of the liver, lung, kidney and bone, including otherwise inoperable cases. In Feb 2013, the company was bought by AngioDynamics (a major international provider of healthcare devices) for $15m. This acquisition is expected to provide a major boost to both the reach of the life-saving MTA technology and global sales. Currently Microsulis employ around 20 people at their base near Portsmouth, producing and developing their MTA devices. Their sales revenue since 2008 totals over £11m.
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 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.
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.