Impact case study database

The Stem Cell Group’s research on biomaterials, stem cells and regenerative medicine led to ground-breaking, cost-saving approaches to clinical practice that have significantly enhanced patients’ quality of life. It has had an economic impact through the formation of a spinout company to commercialise the next generation of biomaterial treatments. Through creative public engagement initiatives, it has increased the public’s understanding of stem cells and enjoyment of science, inspired a series of collaborations between the University and Winchester Science Centre, and stimulated interest among GSCE students in STEM study and careers.

Improving quality of life for hard-to-treat patients through pioneering, cost-saving changes to clinical practice

The underpinning research led to the first patient in the UK being treated with a stem-cell augmented 3D-printed hip replacement in 2014. This was reported widely in the national and international media, including reports on the BBC, Sky News, Research Councils and industrial organisations [ 5.1]. The patient, 71-year-old Meryl Richards from Hampshire, had undergone six hip operations since a traffic accident in 1977. In December 2020, seven years after the surgery, Mrs Richards remains pain free and mobile.

Subsequently, 20 patients have been treated in Southampton using this technique, some of whom contacted the Southampton team directly after reading the 2014 media reports. Follow-up studies, including an 11-patient case series published in 2018, demonstrated the impact of this treatment. New bone was formed in challenging clinical cases, important as these large custom-made 3D printed implants are usually an operation of last resort in patients with reduced biological potential, caused by previous implant effects and increasing patient age [ 5.2].

A review of all 20 patients presented at the Wessex Gauvain Society Annual Meeting in 2020 showed no one needed to have their implant replaced or suffered any dislocations or fractures. Pre-operation, many of these patients were immobile, with some reliant on a wheelchair. Post operation, there was significant improvement in the patients’ Oxford Hip Score, a patient reported outcome measuring hip function and pain with return to much improved mobility level. [ 5.3] To date no implants have been revised. As orthopaedic revision burden increases, the frequency of the most challenging cases has increased with nearly 33% of revisions being re revisions. These re revisions are three times more likely to fail. Given there are 3,150 revisions a year, albeit not generally as complex as the Southampton group’s series, a 6% revision rate after 12 months would save the NHS GBP1.6m if we used our stem cell 3D implant approach. Assuming a best case scenario, application across all 3,150 patients, at 50% implant survival enhancement, would save the NHS GBP34.8m. The UoS series resulted in 100% survival which equates to GBP3.2m saving for the NHS. If applied only to complex revisions such as Southampton’s, then assuming 10% were of similar complexity, this would still save the NHS a total of GBP3.5m. The intervention has therefore transformed patient lives and demonstrated significant cost savings, through fewer revisions, as well as improved patient quality of life.

Delivering economic impact through clinical innovations and commercialisation of underpinning research

Oreffo and Dunlop’s 3D-printed hip research was responsible for significant commercial revenue growth for Materialise NV, the Nasdaq-listed company which produced the hip implant. Brigitte de Vet-Veithen, Vice President of Materialise Medical, wrote: ‘ *The research from Prof. Dunlop and the University of Southampton Bone Research Group has contributed to create strong clinical outcomes of our personalized aMace implant. Their work has helped us to better position this solution in the market and as such expand the treatment to more patients in need to break the revision cycle. The resulting growth of our aMace implant has over proportionally contributed to the 17.6% revenue growth of Materialise’s medical devices and services in 2019.*’ [ 5.4]

Oreffo and Dawson co-founded spin out Renovos Biologics Limited, a regenerative medicine company, in 2017; the underpinning science outlined in [ 3.6] was protected in a patent family [ 5.5, 5.6]. Renovos is pioneering its nanoclay gel technology platform Renovite®, which addresses an unmet clinical need for long-term tissue regeneration for patients with debilitating bone and joint conditions ; it acts as injectable scaffold that attracts cells and localises and retains delivered biologics at ultra-low doses for safer and more efficient regenerative medicine applications. Market research with key opinion leaders affirmed the commercial and clinical potential of the technology. For example, Prof Ashraf Ayoub, Oral and Maxillofacial Surgery, Glasgow, recognised the USP of the nanoclay gels, stressing the ‘ huge need for an injectable and easy to apply delivery material for bone morphogenetic protein’. Steve Charlesbois, Director of Orthobiologics, Cook Regentec, stated: ‘ This biomaterial has big potential in orthobiologics delivery’ and Ian Dunkley, Senior R&D Engineer at Medtronic, emphasised ‘ the need for a safe delivery carrier that stays where it’s delivered’ and endorsed the minimally invasive delivery technology as an approach that ‘aligns with [their] strategy’.

This demonstrable unmet clinical need has resulted in Renovos raising GBP870,000 from public (e.g. Innovate UK) and private sector funding to the end of the impact period. This included a GBP140,000 investment in February 2020 by charity Orthopaedic Research UK and healthcare accelerator HS [ 5.7]. Dr James Somauroo, HS Founding Partner, said: ‘ *It quickly became apparent that Renovos has the potential to fundamentally change the way extremely powerful and sometimes harmful drugs are given around bone. During the interview phase we were impressed by the immense knowledge and expertise of the team and we’re now excited to join the journey and to use our networks to help take them to the next level.*’ [ 5.7].

Renevos’ other commercial propositions include the supply of primary mesenchymal stem cells for research and the delivery of contract research to those carrying out R&D in biomaterials and orthopaedic compounds [ 5.6]. Renovos has generated initial sales of skeletal stem cells worth GBP24,500 via a licensing agreement with European distributor Caltag Medsystems [ 5.6]. This commercial activity enabled the company to create 3.5 FTE employment positions (two scientists, a development manager, Executive Chairman and an administrative role).

Increasing public understanding of stem cell biology and stimulating interest in STEM study and employment

A series of workshops and lab visits for teenagers, based on the Southampton group’s published work and research interests in clay biomaterials and stem cells, took place between 2014 and 2019. Led by Dr Nick Evans, in partnership with educational charity The Smallpeice Trust, 142 students aged 15 to 16 completed workshops; 91.6% of males and 85.3% of females agreed with the statement: ‘ This course has increased your interest in engineering generally’, and 48.3% of males and 54.9% of females agreed with the statement: ‘ This course has persuaded you to follow a career in this field of engineering.’ Of those students who selected science or engineering degrees at university and participated in the Southampton course during the REF period, 84.8% (28/33) said the course had ‘ increased interest in the subject’ and 26.8% (9/34) said the course directly ‘ influenced (their) degree choice’ [ 5.8].

The research on stem cell differentiation to bone led to the conception and creation of a large exhibit to communicate stem cell potential and differentiation. The ‘Stem Cell Mountain’ was designed by Dawson and Dr Ben Ward, CEO at the Winchester Science Centre (WSC), in the University’s first formal collaborative partnership with WSC in 2014. It has since been taken to around 30 festivals including Glastonbury, Cheltenham Science Festival and Countryfile Live. During an impact assessment across six events in 2015, the exhibit was seen by 21,100 people and facilitated in-depth engagement with 7,450 people on the subject of stem cells and regenerative medicine [ 5.9].

Due to its popularity, additional funding from Dawson’s fellowship and WSC workshop funds were allocated to build a permanent replica, which continues to be resident at the Winchester Science Centre (WSC) . During an assessment period undertaken by WSC between 30 April 2015 and 29 November 2018, it reached 613,219 people (133,960 school children, year R-year 9, and 450,709 members of the public). The Stem Cell Mountain consistently receives positive user feedback. Representative examples include: ‘The stem cell mountain – thank you for having this idea. It’s such a clever way to explain the concept’; ‘Such a simple way to represent a very complicated thing’; ‘We need science like this in school. It’s so much more interesting’; ‘I was considering doing a PhD at one point – I didn’t think I’d reconsider it here’ [ 5.9].

As the first successful partnership between the University and WSC, the Stem Cell Mountain led to 11 more joint projects amounting to a value of GBP500,000 and a formal memorandum of understanding between the two organisations in a public engagement partnership inaugurated by the Vice-Chancellor in September 2017. Dr Ben Ward sums up its success: ‘ It has been instrumental in trail blazing an ongoing and fruitful collaborative relationship between our two organisations’ and ‘The Stem Cell Mountain is now one of our most popular exhibits with our visitors, and we see it as a perfect example of how we blend education with fun at the Centre - engaging children and adults alike with science.’ [ 5.10]