Clinical clay creations

As the population’s life expectancy improves, the number of people suffering from conditions associated with living longer, in particular musculoskeletal conditions, increases. An already stretched NHS requires solutions and treatments that enable age-related ailments to be treated swiftly and cost effectively, leading to some pioneering technological advances from a University of Southampton spin-out company and a charitable collaboration which is the first of its kind.

Clay is at the heart of spin-out company Renovos’ pioneering advances in the field of orthopaedics.

“Using clays in medical treatments is not new, but the advances being made certainly are innovative,” explained Richard Oreffo, Professor of Musculoskeletal Science, Director of the Centre for Human Development, Stem Cells and Regeneration (CHDSCR) and Co-founder and Chief Scientific Officer for regenerative medicine spin-out company, Renovos. “Clays have been used in tablets to control drug release through their molecule binding properties for many years. These binding properties ensure that molecules stay localised, which is essential in directing the activity of stem cells.”

Renovos is pioneering a new nanoclay gel technology, which has the potential to transform orthopaedic surgery.

“For what is essentially quite a low-tech material, clay is proving to have tremendous potential in this area,” said Richard. “The gel allows significantly lower doses of powerful regenerative therapeutic agents to be precisely delivered by injection and localised to bone sites where needed as well as acting as a scaffold.”

Co-founder and world-leading nanoclay expert Dr Jonathan Dawson outlined: “Early trial data demonstrates that nanoclay gel technology contributes to improved bone healing. This consequently offers a stepchange improvement in safety, efficacy and ease of use, as well as reduced adverse events and complications compared with current orthopaedic interventions, such as clinically used Bone Morphogenic Protein, or BMP, therapies.”

The company’s first product, Renovite ® BMP- 2 gel, is aimed at orthopaedic applications such as spinal fusion, bone defects and ankle surgery for effective, localised bone formation. The nanoclay gel is injectable, which makes it easy to use and cost-effective due to needing a reduced dose through improved localisation and efficacy.

Rich history

Richard, who has led the CHDSCR since its formation in 2004, explained: “Regenerative medicine develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues harnessing the use of therapeutic stem cells, tissue engineering and the production of artificial organs – ultimately we seek to improve the healing process and therefore relieve pain and return patients to healthy life.”

Stem Cell Mountain

The CHDSCR is at the forefront of such work. Work in the Bone and Joint Research Group explores using skeletal stem cells and novel biomaterial scaffolds for the treatment of bone damage and disease. It also led to the creation of Renovos.

“The CHDSCR’s ultimate goal is to undertake fundamental research into early development and stem cells together with applied translational research to achieve patient benefit,” said Richard. “We have vibrant and thriving interdisciplinary research programmes together with an innovative Stem Cell MRes programme, outstanding clinical infrastructure and enterprise to help us achieve our aim.” [Translational research, often referred to as bench-to-clinic, applies knowledge from basic biology and clinical trials to create new therapies, medical procedure or diagnostics to address critical medical needs.]

Within the musculoskeletal arena, it is predicted that the numbers of hip fractures worldwide will increase from 1.7 million in 1990 to 6.3 million in 2050.

One of the major orthopaedic success stories of the last 50 years has been the hip replacement, a common type of surgery where a damaged hip joint is replaced with an artificial one. However, with time a hip replacement can fail, requiring revision. “We have been developing approaches, with Professor Douglas Dunlop, Consultant Orthopaedic Surgeon, to tackle the most challenging hip revision clinical cases,” said Richard. “It was in 2014 that we undertook the first skeletal stem cell augmented 3D-printed titanium hip replacement, which, to date, has shown extremely positive clinical outcomes.”

Charity collaboration

In 2020, Renovos secured the first ever investment from Orthopaedic Research UK (ORUK), a charity funding high quality research and education into musculoskeletal science.

“We went through an extremely rigorous and labour-intensive selection process with ORUK to secure the first ever investment of its type from them – £140,000 to support and develop our nanoclay gel technology,” explained Jonathan.

“The charity has very much transformed its funding model in order to provide investment to start-up companies such as ours. As well as it being fantastic to be their first investment, ORUK are extremely well placed to help us establish the networks we need with clinicians and patient groups as we approach clinical trials.”

The newly-launched Ronald Furlong Fund from ORUK was established in memory of the charity’s founder.

Grassroots

Jonathan and Richard are both passionate about engaging with children and young people regarding their research and the power of stem cell technologies.

In 2014, Jonathan led the creation of a public engagement exhibit, Stem Cell Mountain, in partnership with the Winchester Science Centre as part of an ongoing collaboration.

“We wanted to create a fun and engaging way to communicate important research into stem cells to children and families,” explained Jonathan. “Combining the fun of a pinball machine with key biological concepts, Stem Cell Mountain brings to life the complex idea of stem cell potential.”

The BBSRC award-winning hands-on exhibit has engaged festivalgoers at Glastonbury, Bestival and BBC Countryfile Live, as well as at the UK’s top science festivals. It has also proved immensely popular with the 250,000 people who visit the Winchester Science Centre every year, where it resides when not on the road.

Jonathan added: “Stem Cell Mountain helps users learn about how stem cells could be used to repair our bodies. The exhibit has wheels to turn that send ‘stem cells’ spinning down a giant marble run, and levers to pull to direct them towards various cell-type destinations. It really captures the imagination about what stem cells could make possible.”

Future potential

These are exciting times for regenerative medicine, with the potential to harness innovative molecular tools, in-vitro models including organoids, organ-on-a-chip and 3D bioprinting, and to explore new approaches such as artificial intelligence to address a variety of unmet critical medical needs.

Many of these areas are a focus of research across various tissue types within the CHDSCR.

Richard concluded: “Within the translational enterprise space, a key step within Renovos will be to deliver on the promise of regenerative medicine. This will involve developing additional nanoclay platforms to localise stem cells and appropriate cues, or growth factors, delivered and presented at physiological doses within the right local microenvironment. This will create regenerative medicine products with improved safety and performance that will enhance tissue regeneration.

“The future is bright within regenerative medicine and the key now will be to deliver on the promise to translate our understanding of tissue regeneration and move through concept to reality.”

FROM PHD TO CEO

In just four years, Dr Agnieszka Janeczek has gone from undertaking a PhD to becoming a founding partner and the CEO of a successful biotech start-up company, Renovos. Her chosen route from academia to a business commercialising innovative technologies is one she hopes will inspire other women in the field of research.

“I knew right from the beginning of my research career that I wanted to work in biomedicine in some capacity and translate science to patients,” explained Agnieszka. “I am fascinated by the science of regenerative medicine and I also have an entrepreneurial spirit, so bringing together my two passions has been an ideal collaboration.”

Before coming to Southampton in 2011 for her PhD, Agnieszka undertook a Master’s in Medical Biotechnology at the Poznan University of Medical Sciences in Poland.

“My Master’s research focused on deriving and testing genetically modified muscle stem cells as a regenerative medicine therapy for application in myocardial infarction,” she explained. “This led very naturally to my PhD in another area of stem cell therapy research, which was looking at targeting skeletal stem cells for bone regeneration. It was during my PhD that I started working with the Bone and Joint Research Group and discovered not only a research area that I loved but also a group of fantastic colleagues that really inspired me.”

Post-PhD, Agnieszka secured support from the SETsquared ICURe and Southampton Science Park Catalyst Business Programmes, enabling her to receive business training and gather relevant market research internationally, which proved market demand for biomaterials and techniques for musculoskeletal regeneration.

“The market research involved interactions with more than 100 potential customers, partners, key opinion leaders and investors and was the catalyst for creating Renovos,” Agnieszka said. “I collated the results and worked with my team to create a viable business plan, apply for Innovate UK funding and deliver pitches to investors.”

And so Renovos was born.

Having worked on the business from the idea stage to a fully operational biotech start-up, Agnieszka has gained a breadth of experience in drug and device development, regulatory compliance, fundraising, management, and strategic leadership.

“Proactive networking is definitely key for transitioning from an academic to a commercial setting,” she said. “And although the path is rarely linear, accomplishing something at every career juncture shows resilience which is needed in a biomedical start-up environment.”

Renovos is revolutionising orthopaedics and regenerative medicine by developing Renovite ® , a novel nanoclay gel biomaterial, that can ultimately offer safer and more economic clinical solutions for tissue regeneration.

“My day-to-day role is to lead on business development activities and operations and oversee the commercial development of our Renovite ® nanoclay product portfolio. My passion for regenerative medicine and innovation is ignited daily,” concluded Agnieszka. “I am very proud of what we have been able to create with Renovos and what the future holds.”

Dr Agnieszka Janeczek

For further information, visit: www.renovos.co.uk