In this Q&A, Dr Jen Edwards, University Academic Fellow in Musculoskeletal Medical Technologies at the University of Leeds, discusses how our funding opportunities helped to progress her project towards real patient benefit.
Project summary: Acellular biological scaffolds developed at the University of Leeds repair and replace human tissue. Called dCell®, the technology has been commercialised through Tissue Regenix and products for woundcare and cardiovascular applications have already reached the market.
I am investigating ways to remove cells from donated adipose tissue. The aim is to produce an implantable product that surgeons can use in reconstructive surgery without triggering an immune response. Working in collaboration with NHS Blood and Transplant, I am looking particularly at developing decellularised adipose gels that can be used to treat diabetic foot ulcers.
Collaborators: Tissue Regenix, NHSBT, Leeds Teaching Hospital Trust
Q. How have you found working with co-development partners and what benefits has it brought to your technology?
The funding I have received from Grow MedTech has enabled me to work independently with partners in NHS Blood and Transplant to develop my ideas. This has been a great introduction to how to work with them to design processes which can be used by their manufacturing teams easily. It has given me the confidence in myself and my ideas to do this without direct guidance from a more experienced academic.
Q. Where was your career and project when Grow Medtech got involved?
I had been a postdoctoral research fellow at Leeds for seven years. I was involved in several IKC supported projects to understand how decellularised tendon scaffolds would function when used to repair the anterior cruciate ligament in the knee. This provided important evidence for the potential of these scaffolds to successfully and safely treat patients. For a year, my salary was funded by an IKC Proof of Concept study in collaboration with NHS Blood and Transplant (NHSBT). This work developed a sterilisation method for decellularised human bone-tendon-bone grafts which is suitable for use by NHSBT in their production facilities.
During my postdoctoral role, I was fortunate to have the opportunity to conduct some of my own research and I developed a protocol for decellularisation of porcine adipose – body fat – tissue. I was then awarded Grow MedTech Proof of Feasibility funding to translate this protocol to human donor adipose tissue, with the support of NHS Blood and Transplant.
The purpose of decellularisation is to remove cells and cellular proteins from a tissue but maintain the integrity of the extracellular matrix (comprised of structural proteins and other biological molecules). The resulting scaffold can be used to repair or replace damaged tissue without the risk of an adverse immune reaction to cellular proteins, whilst still providing complex biological cues and biomechanical function.
The approach could create a new product for an unmet clinical need – restoration of the plantar fat pad in diabetic patients to prevent them developing diabetic foot ulcers. The prevalence of diabetes in the UK was estimated at 3.5 million patients in 2015. 2-3% of these patients are thought to have an active foot ulcer at any time, with 5-7% of diabetic patients affected at some point in their lifetime.
The idea was to inject decellularised adipose to the fat pads in the sole of the foot to reduce the pressure on the skin and prevent ulcers developing. In diabetic patients, it is better to avoid cutting the skin on the foot and Davis Russell, a Consultant Vascular Surgeon, was keen on a solution that’s injectable for this reason.
Many treatment options at the moment use bulky footwear to reduce pressure on the foot, which do not fit in well with patient’s lives. This approach could improve treatment over these current options by instead providing long term regeneration. As it is made from donor adipose, it would be possible to repeat the injection, unlike the silicone injections which have been trialled in some patients.
Q. How did Grow MedTech and Translate MedTech help?
Grow MedTech funded three of my projects: a Proof of Feasibility and two Proof of Market studies.
The PoF gave me the experience of applying for funding as a post-doc and provided me with one day a week to generate pilot data and give a solid starting point to the research. I could see an end impact point with NHSBT – an easy route to the product and process being used. This new independent collaboration gave me more confidence in talking to new and existing collaborators.
I then was awarded a Proof of Market to carry out an in-depth analyses of the commercial and competitive landscape for decellularised adipose. This included a better understanding of the potential costs of treatment compared with current products and solutions and an overview of the opportunities and regulations for human adipose tissue outside of the UK.
I also won a Proof of Market for my decellularised bone-tendon graft project. Acute damage to ligament and tendon tissue places a burden on healthcare systems around the globe. These tissues heal poorly and tears must often be repaired surgically, requiring a replacement tissue. Tissue allografts can be successful, but the donor cells can cause an adverse immune response, delaying healing and recovery. My PoM study aimed to understand the routes to market and clinical applications of the decellularised porcine and human bone-tendon grafts, and again, understand the opportunities outside of the UK and how they would be regulated.
Grow MedTech has been invaluable in flagging other relevant opportunities, like an internal fund for impact which was available. With the support of the team, I am able to focus on relevant opportunities and continue to gather the necessary evidence to translate my work for patient benefit.
Q. How has your career developed during the project?
When I was part-way through my PoF project I secured a University Academic Fellow (UAF) post. UAF is a structured five-year development programme that leads to you becoming an Associate Professor, so this was a real pivotal moment in my career.
Being awarded PoF funding really helped in my application as generally postdoctoral researchers aren’t eligible for most funding, so I could demonstrate some success in winning bids. It also gave me the confidence in my ideas and a space to explore leading my own research on a small scale.
I am also revising a Future Leaders Fellowship submission. It provides funding up to seven years both to tackle ambitious and challenging research and innovation and to develop your career. Grow MedTech has provide input and comments and the application will be submitted in January. The PoM project has provided clear evidence for the importance of the work I wish to develop – that everything has been thought about around where in the market it will fit.
Q. What is the most unique or interesting thing about this project?
Probably the unexpected opportunities it has brought me. I now have a further project to work with real patient tissues and understand how they behave. More than that was the opportunity to work with the Thackray Medical Museum in developing a new exhibit. They saw the Grow MedTech mid-term report and got in touch with the team to try and display some of the work. I already had a reputation as someone very keen on public engagement and was asked to lead on this at the start. By working with Grow MedTech, we were able to design an exhibit which will showcase six of their funded projects once the Museum reopens. I am also hoping to maintain future links with the Museum to develop an interactive exhibit around the research within the Institute of Medical and Biological Engineering.
Q. How did you first get involved in your specialist area? What sparked the idea?
I was part of a clinical immersion project, where I was able to spend two weeks shadowing clinicians. One of the opportunities was spending a day in the Leeds Limb Salvage Service, where I met Mr David Russell. Talking to him made me realise that there are surgeons who value academic input to solve their clinical challenges. Over time, I developed the idea of decellularised adipose, using the skills I had developed as a postdoc. The continued enthusiasm of Dave has helped me shape this idea into something which could provide real patient benefit through the NHS.
Q. What inspires you?
Opportunities to be curious and change the world around us. I love learning new things; even better when they could potentially improve lives. Better still when I get to talk about them with other people.
Q. What impact do you hope your work will have on the world?
A combination of things. The most obvious is patient benefit to improve quality of life and reduce complications. I hope the research can tell us more about the healing process and lead to other treatments in the future. More than that, I hope that I can inspire more people to see how fascinating science and engineering can be.