A new direction in regenerative medicine: Eileen Ingham and John Fisher named European Inventor Award 2018 finalists
- British immunologist Eileen Ingham and bioengineer John Fisher CBE, nominated for European Patent Office (EPO) prize for inventing biological scaffolds which the body can use to create new tissue
- Husband-wife team co-founded spin-off to commercialise their research
- Their method is currently used as wound care and going through approval for heart valve replacement as well as orthopaedic and surgical applications
- EPO President Battistelli: "Ingham and Fisher's innovations demonstrate that European research is advancing regenerative medicine with the potential to improve quality of life for our ageing populations."
Munich, 24 April 2018 - Rising life expectancy, along with an increasing incidence in chronic illnesses such as diabetes, heart disease and obesity, is putting a strain on our bodies. We are getting much more use out of our joints, tendons and heart valves than ever before. A fresh approach to regenerative medicine developed by British husband-and-wife team, immunologist Eileen Ingham and bioengineer John Fisher, could provide an answer to overuse and extra wear as well as treat complications of certain diseases. Their decellularisation process removes almost all DNA and cellular material from tissue to leave a scaffold that can be remodelled by a patient's own cells. It is currently used to create new skin, heart valves and tendons, all of which do not trigger the adverse immune response typical of foreign tissue, and it may one day open the possibility for complete replacement organs, that the body grows itself.
For this achievement, Ingham and Fisher have been
nominated for the European Inventor Award 2018 as finalists in the
"Research" category. The winners of this year's edition of the EPO's annual innovation prize will be announced
at a ceremony in Paris, Saint-Germain-en-Laye, on 7 June 2018.
"Ingham and Fisher's innovations demonstrate that European medical research is advancing the field of regenerative medicine," said EPO President Benoît Battistelli, announcing the European Inventor Award 2018 finalists. "Uniting their skills as immunologist and bioengineer, their method has the potential to improve quality of life for our ageing populations."
Building biological scaffolds
The result of Ingham and Fisher's combined work is a novel decellularisation process, protected by European patents, that creates a cell-based biocompatible scaffold ex vivo. This scaffold structure can then be transplanted into or grafted onto the patient and regenerated with the patient's own cells. The process works by gently "washing" donated tissue to produce an organic structure that has the same physical form and function as the original tissue, but contains no cells.
"The reason this process is both novel and distinctive," says Fisher, "is its ability to recreate the scaffold as a tissue-specific scaffold that, when implanted, matches the properties of the tissue that is being repaired or replaced."
As a platform technology, Ingham and Fisher's technique can be used in a wide range of medical applications. It has already proved effective for creating replacements of body structures of one specific tissue type, such as skin, heart valves and tendons. It is also being developed for further replacement of tissues that are a combination of hard substances such as bone and soft tissues, including ligaments, meniscus, or cartilage. Other researchers have taken Ingham and Fisher's lead and are exploring the technology to create even more complex cellular structures such as nerves.
The husband-and-wife team developed their technology at the University of Leeds and, in order to bring their invention to market, they co-founded the University of Leeds spin-off company Tissue Regenix in 2006, which has licenced the core patents from the university, as well as strengthening its portfolio with more patents of its own. Tissue Regenix subsequently became Tissue Regenix Group PLC, where the inventors' technology has been commercialised under the name dCELL®. The method is employed to produce and develop a range of medical implants and treatments in the areas of wound care, heart valve replacement as well as orthopaedic and surgical applications.
Improving quality of life
Currently the most promising application of the decellularisation process is in treatment of diabetic foot ulcers, which affects an estimated 6% of the roughly 415 million diabetics worldwide. Decellularised human skin is used to repair the wounds associated with diabetes mellitus, and the treatment is approved for use in both the US and UK.
Cardiovascular diseases are another promising area for treatment. Replacement heart valves - one of Fisher's areas of specialty - are made from human donor valves and removed of their cellular material via the decellularisation technique. The decellularisation process removes almost all cellular matter from the replacement valves and ensures they do not trigger an immune response in the recipient. Conventional mechanical valves require post-operative medication and conventional biological valves calcify over time. Decellularised valves appear to produce lower amounts of calcification. After successful clinical tests in Brazil for over ten years, this application is progressing through the German regulatory application processes for use in the EU.
To help alleviate the strain and pain of soft-tissue injuries to joints, such as knees and ankles, Tissue Regenix Group has developed replacement tendon options, made from either pig or human donors, which are being used for regenerative orthopaedic treatments. EU clinical trials are being conducted, and the company expects approval and its first orthopaedic tendons to be available this year.
Tissue Regenix operates in a wound care market currently estimated to be worth EUR 15.8 billion and forecast for strong growth, reaching EUR 19 billion by 2022. Supported largely by it US FDA-approved wound care product, the company's annual revenues grew sharply from EUR 6 700 in 2014 to EUR 1.6 million in 2016. According to the group's latest annual results, revenues increased to EUR 6 million in 2017.
An innovative partnership
A telephone call over 25 years ago launched a partnership between Ingham and Fisher that has brought together the physical science of Fisher's engineering background with Ingham's biological expertise. The partnership has generated world-recognised research, and between them they have published more than 700 peer-reviewed papers.
Eileen Ingham first arrived at the University of Leeds in 1972 as an undergraduate studying biochemistry and microbiology, where she subsequently went on to obtain her doctorate in immunology and later become Professor of Medical Immunology of the University's Faculty of Biological Sciences, a position she has held since 2000. As a champion of women in science, Ingham has been recognised by the Suffrage Science scheme, which celebrates women in science for their achievements and their ability to inspire others. Her additional awards include the Queens Anniversary Award for Higher and Further Education (2012) and the Woman of Outstanding Achievement from the UK Resource Centre for Women in Science, Engineering and Technology (2011). An esteemed scientist and innovator, Ingham is listed as the inventor on ten patents, five of which relate to acellular biological scaffolds.
John Fisher has over 40 years of experience in medical engineering research innovation and development. He was recognised for his services to biomedical engineering when he was appointed a Commander of the Order of the British Empire (CBE) in 2012. Fisher gained his PhD in bioengineering from Glasgow University and joined the University of Leeds in 1988 as Lecturer in Biomedical Engineering. He served as Pro Vice Chancellor and Deputy Vice-Chancellor at the University of Leeds for 15 years until he stepped down in 2016.
Ingham and Fisher were co-founders of the University of Leeds' Institute of Medical & Biological Engineering (iMBE), which is globally recognised as one the top centres for research and innovation in medical engineering. It has 100 academic researchers and external grant income of more than EUR 57 million.
The success of Ingham and Fisher's relationship extends beyond the lab. They have been married since 1995 and share an interest in maintaining a healthy lifestyle through walking, running and going to the gym. Although they live in Leeds, they are passionate supporters and season ticket holders for the Manchester United football team - Ingham's hometown team.
Despite setting up what has become a successful international business, the two still spend most of their time in the laboratory, continuing to further their decellularisation research and develop new life-changing innovations: "We are, at heart, academics," says Fisher. "Our joy comes from that moment when something we believe is possible becomes a reality." Ingham agrees: "There's a real buzz in discovering something new and we're not going to give that up for a life in the corporate world."
Additional resources
Download our app " Innovation TV " to your smart TV and watch video portraits of all finalists on your TV screen
View the patents: EP1392372 , EP2094325 , EP1624922
Husband and wife teams
A team in both their professional and personal lives, Ingham and Fisher are not the first couple to be recognized by the European Inventor Award. The lifelong partnership of Erwin and Ingeborg Hochmair (finalists 2014) made them the only couple to be nominated in the Lifetime achievement category (Ingeborg went on to serve on the Award jury for three years). A Portuguese couple were also nominated - Elvira Fortunato and Rodrigo Martins - to become finalists in the Research category in 2016.
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