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Leeds marks milestone in international clinical trial for Prosthetic Joint Infection treatment 

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An operating theatre at Leeds Teaching Hospitals NHS Trust

A clinical trial of a new product to treat Prosthetic Joint Infection (PJI) has recruited the first three patients outside the USA. Thanks to the collaboration between Leeds Teaching Hospitals, the University of Leeds, NIHR Clinical Research Facility: Leeds, and NIHR Biomedical Research Centre: Leeds, the patients were treated within 25 days of their recruitment. 

RETAIN is a global phase 2/3 double-blind clinical trial of an investigational antimicrobial peptide, zaloganan, designed by US firm Peptilogics to treat PJI. While PJI affects about two percent of joint replacements, it can cause significant problems for patients and often requires repeated surgeries to clean out the infection and replace the artificial joint. 

The trial is testing the impact on patient outcomes of an antimicrobial peptide, zaloganan, designed to tackle the bacterial biofilm that protects infection in cases of PJI and which makes the condition difficult to treat.

Professor Hemant Pandit, Professor of Orthopaedic Surgery at the University of Leeds and Honorary Consultant Orthopaedic Surgeon at Leeds Teaching Hospitals NHS Trust, and workstream lead for surgical technology at the NIHR Biomedical Research Centre: Leeds, said: “While the vast majority of knee replacement surgeries help patients move more freely and live with less pain, prosthetic joint infection is a very serious complication that can require repeated surgeries with increased risk of mortality in the most extreme cases. The diagnosis and optimal management of PJI remains challenging to surgeons, and the condition often leaves behind permanent and life-changing effects that negatively impact the patient’s limb function and overall quality of life.” 

Mr Jeya Palan, Consultant Orthopaedic Surgeon and Honorary Senior Clinical Lecturer at the University of Leeds, and co-investigator on the RETAIN trial, said: “PJI can be clinically challenging and can require multiple procedures and have unpredictable outcomes. Finding new clinical practices and options for successful treatment of this serious condition is vital to improving the outcome for patients.” 

Led by Investigators, Professor Pandit and Mr Palan, Leeds Teaching Hospitals is one of 15 sites in the UK taking part in the RETAIN trial.  

Peptilogics is a clinical stage biotech company dedicated to curing and preventing medical device-related infections (MDRI). More information about the RETAIN trial can be found on the Peptilogics website.

Leeds first to dose patients in pioneering cell therapy study for autoimmune diseases

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Leeds Teaching Hospitals NHS Trust has marked an important milestone in the development of a potential new treatment for people living with difficult-to-treat autoimmune diseases, after the first patient was treated in the CHILL Phase 1/2 clinical study.

The multi-national study, delivered in Leeds by the National Institute for Health and Care Research (NIHR) Clinical Research Facility: Leeds, is evaluating QEL-005, an investigational CD19 B-cell activated engineered regulatory T cell therapy developed by Quell Therapeutics for people with difficult-to-treat rheumatoid arthritis and systemic sclerosis.

Almost half a million people in the UK have rheumatoid arthritis, and an estimated 19,000 have systemic sclerosis and this study is exploring a potential new one-time treatment for these conditions.  It involves a new type of ‘cell therapy’ that uses a patient’s own immune cells – called T-regulatory cells or Treg cells – which are collected from the blood, engineered and enhanced in the lab, and then returned to the patient.  Regulatory T cells (Tregs) are specialized immune cells that keep the immune system in balance, calming excessive responses and helping prevent tissue damage. 

The first participant in the CHILL study received treatment at Leeds Teaching Hospitals, making the Trust the first site worldwide to treat a patient in the trial. Two further patients have since been treated at Oxford University Hospitals NHS Foundation Trust, completing the study’s first dose cohort.  Quell Therapeutics has now announced that the study has progressed to its second planned dose cohort following a positive safety review.

The CHILL study is recruiting participants across seven sites in the UK and a further four sites in Germany and Spain.  Led in Leeds by Principal Investigator, Professor Francesco Del Galdo and delivered by NIHR Clinical Research Facility: Leeds in close collaboration with clinicians in haematology, including Dr Jonny Carmichael, and rheumatology experts, the trial brings together a multidisciplinary team of research and clinical experts from across the Trust and draws of the expertise and research infrastructure of the NIHR Biomedical Research Centre: Leeds, which supports pioneering research into connective tissue disease and autoinflammatory diseases.

Prof Francesco Del Galdo, Principal Investigator at Leeds Teaching Hospitals NHS Trust, said “We were thrilled to see the first CHILL patient globally receive this new intervention at Leeds Teaching Hospitals. Patient safety was central to our preparations, with the multidisciplinary team working closely together to support and monitor the patient throughout. The team worked together admirably and it was rewarding to see the patient able to return home the following day after dosing.”

Prof Francesco Del Galdo, Principal Investigator at Leeds Teaching Hospitals NHS Trust

Professor Chris Twelves, Director of the NIHR Clinical Research Facility: Leeds, said:  “At Leeds Teaching Hospitals, we have extensive experience delivering early-phase advanced therapy trials safely and effectively, especially for people with blood cancers. The CHILL study is the first time we have brought together specialist teams across the Trust and colleagues at the University of Leeds to deliver this type of advanced therapy for autoimmune disease. We’re delighted to be the first site to safely recruit and commence treatment to the first patient within two weeks of the trial opening.  This has been possible thanks to close collaboration and commitment of our specialist clinical and research teams working together.  By exploring whether these innovative treatments are safe and effective in conditions that are difficult to treat, we hope to pave the way for new treatments for patients in the future.”

A picture of Professor Chris Twelves.
Professor Chris Twelves, Director of the NIHR Clinical Research Facility: Leeds

Dr Jonny Carmichael, consultant haematology at Leeds Teaching Hospitals NHS Trust commented:  “In advanced therapy such as this, collaboration is essential. By bringing together the rheumatology, haematology and NIHR CRF: Leeds teams from Leeds Teaching Hospitals NHS Trust and the University of Leeds, we brought together the expertise to identify suitable participants, navigate the complexities of trial delivery and deliver high-quality innovative care for our patients, ensuring we deliver research safely and efficiently.”

The multi-disciplinary team involved in the CHILL study at Leeds Teaching Hospitals.  Jena English, Hannah Newman, Angela Bennett, Dr Jonny Carmichael, Dr Michele Stanciu, Prof Chris Twelves and Dr Andrea Di Matteo.

The trial is part of Leeds Teaching Hospitals’ growing portfolio of advanced therapy clinical research and reflects the Trust’s commitment to bringing innovative treatments to patients through research.

If successful, QEL-005 could offer a new transformational treatment approach for people living with complex autoimmune diseases where existing therapies have not provided sufficient benefit.  Initial clinical data from the study is expected in 2027.

The CHILL study is delivered by NIHR Clinical Research Facility: Leeds at its state-of the-art clinical research facility at St James University Hospital.  

For more detail about the rapid set up of the trial, please visit the Advanced Therapy Treatment Centres website.

For more information about the QUELL study, please visit https://www.chillstudy.life/

NIHR Staff Profile: Nachammai Swaminathan

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Photo of Nachammai Swaminathan

Helping make research more inclusive across Leeds

As a Public and Patient Involvement and Engagement (PPIE) Officer at NIHR Clinical Research Facility: Leeds and Leeds Teaching Hospitals NHS Trust, Nachammai Swaminathan is passionate about ensuring research reflects and includes the communities it aims to serve.

Working as part of the NIHR PPIE strategy across Leeds research including NIHR Clinical Research Facility: Leeds, Nachammai supports patient and public involvement in research, with a particular focus on underserved and underrepresented communities.

A key part of her role involves building trusted relationships with local organisations, charities, community leaders and partners to help make research more accessible, inclusive and community focused. Her work includes supporting community engagement, co-production activities, condition-specific PPIE groups and outreach initiatives designed to encourage wider participation in research.

Nachammai said: “Through community outreach and relationship-building, I have been able to support people from underserved and research-naïve communities to feel heard, valued and confident contributing to research discussions and activities”.

Through initiatives such as PPI Connect 2025, Hello Hearts sessions and targeted outreach activities, Nachammai has helped create sustainable opportunities for communities to become involved in research conversations and decision-making.

Her work has also supported researchers and colleagues to improve the accessibility and inclusivity of their studies. Feedback gathered through engagement and involvement activities has informed changes to patient-facing materials, communication approaches, study design and engagement strategies across several research areas including cancer, vaccines, antimicrobial resistance and prostate cancer research.

For Nachammai, one of the most rewarding aspects of the role is seeing individuals grow in confidence and become actively involved in shaping research.

“Seeing individuals progress from attending a community session for the first time to joining PPIE groups, contributing to research projects, co-presenting at conferences, or becoming part of steering groups has been especially rewarding,” she added.

Working within NIHR PPIE has further developed Nachammai’s skills and expertise in research engagement, co-production, partnership working and supporting meaningful public involvement.  Through working closely with diverse communities, researchers and healthcare professionals, she has developed skills in community engagement, co-production, partnership working, public speaking and strategic PPIE delivery.

Nachammai said: “What makes me most proud about being involved with NIHR is the opportunity to help make research more inclusive and representative of the communities it aims to serve”.

NIHR Clinical Research Facility: Leeds showcases research excellence at UKCRF Conference in Dublin

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Colleagues from the NIHR Clinical Research Facility (CRF): Leeds joined clinical research professionals from across the UK and Ireland at the UKCRF Conference in Dublin, sharing expertise, presenting research and leading discussions on the future of clinical trials.

NIHR Clinical Research Facility: Leeds was represented by12 colleagues from a wide range of specialities, including pharmacy, dental research and patient and public involvement and engagement (PPIE), reflecting the multidisciplinary expertise that underpins research delivery across its five sites at Leeds Teaching Hospitals NHS. Two colleagues led workshops to share best practice in efficient trial set ups and the team also showcased 12 posters, highlighting innovative work taking place at NIHR Clinical Research Facility: Leeds.

A key highlight of the conference was a keynote address from Dr Alex Churchill, Deputy Director for Clinical Trials Policy and Infrastructure Policy and International Partnerships at the Department of Health and Social Care, who outlined the Government’s ambition to make the UK a global leader in clinical research. His presentation focused on accelerating clinical trial set-up, expanding research into primary and community care settings, strengthening partnerships between the NHS, academia and industry, and creating a more research-active NHS workforce. He also highlighted the increasing role of artificial intelligence and connected data infrastructure in improving trial design, participant recruitment and research delivery.

These themes were reflected throughout the conference programme, with sessions exploring how to deliver the right research in the right setting, improve access and participation in research, harness digital and AI-enabled technologies, strengthen workforce capability, and build national and international collaborations that support faster, more inclusive clinical research. Delegates also heard examples of how streamlined processes and coordinated working across organisations are helping to reduce study set-up times and bring innovative treatments to patients more quickly.

The conference provided an excellent opportunity for the Leeds team to network, share best practice and bring back new ideas that will help further strengthen research delivery for patients across Leeds and the wider region.

Our impact: Personalised pacemaker therapy- better outcomes for patients and the NHS

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Pacemakers are life-changing devices that help people with heart disease live longer and improve their quality of life. However, despite major advances in technology, many pacemakers are still left on standard factory settings rather than being tailored to the individual needs of patients. Researchers at the NIHR Clinical Research Facility (CRF) Leeds have been leading pioneering work to show how a more personalised approach to pacemaker care can improve patient outcomes, reduce hospital admissions and deliver better value for the NHS. Through a series of NIHR-supported studies, the team has helped change the way pacemaker patients are cared for locally, nationally and internationally.

Our Goal

More than 300,000 people in the UK live with a pacemaker, with around 36,000 new devices implanted every year. Researchers wanted to better understand whether personalising pacemaker settings and combining device expertise with heart failure care could improve patients’ health and quality of life. The team also recognised that symptoms such as breathlessness and tiredness in people with pacemakers are often wrongly attributed to ageing or existing heart disease, meaning heart failure can sometimes go undiagnosed and untreated.

Our Approach

Through a series of NIHR-supported clinical trials led from the NIHR Leeds CRF, researchers explored how personalised pacemaker programming and joined-up care could improve outcomes for people living with pacemakers.

The research showed that carefully adjusting pacemaker settings to suit each individual patient could:

  • Improve heart function
  • Reduce unnecessary pacing of the heart
  • Extend pacemaker battery life
  • Reduce the need for replacement surgery
  • Improve exercise capacity and quality of life

One major study involving 1,800 patients across West Yorkshire found that around one-third of people with pacemakers had previously undiagnosed heart failure.

In response, the team developed a new multidisciplinary Combined Heart Failure and Device Clinic at Leeds Teaching Hospitals NHS Trust, bringing together experts in pacemakers and heart failure treatment in one service.

The clinic is staffed by highly trained cardiac physiologists and nurses and now supports more than 300 patients each year.

Real World Impact

The work also helped develop a highly skilled and diverse research workforce, including NIHR-funded clinical researchers, cardiac physiologists and clinicians.

The research has already changed care for patients in Leeds and is influencing practice internationally.

The personalised approach developed through the NIHR Leeds CRF has now been embedded into routine NHS care at Leeds Teaching Hospitals NHS Trust through the Combined Heart Failure and Device Clinic.

Patients are receiving more tailored treatment, helping reduce hospital admissions and improving long-term outcomes.

The work has also contributed to international heart failure and pacemaker guidelines in Canada, America and Europe, helping shape care for people with pacemakers around the world.

Importantly, the research demonstrates how personalised care can improve outcomes while also reducing pressure on the NHS by preventing complications and avoiding unnecessary procedures.

What’s Next

Researchers at NIHR Leeds CRF continue to lead new studies exploring how personalised pacemaker programming can further improve care for people with heart disease.

Upcoming research includes:

  • Exploring new pacemaker lead positions and their effect on heart function
  • Developing simpler ways to personalise heart-rate settings
  • Expanding studies across multiple NHS centres
  • Investigating how personalised programming could benefit people with less severe heart failure

The team is also continuing work to increase awareness and education around personalised pacemaker care through international guideline groups, professional societies and training programmes.

This work would not have been possible without the support of NIHR infrastructure at the NIHR Leeds CRF, helping turn research into real improvements for patients, healthcare services and society.

NIHR 20 Staff Profile: Lorna Gallacher

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Lorna Gallacher

Lorna Gallacher is a Research Nurse for Team 3 – Early Phase Oncology (First-in-Human Clinical Trials) at NIHR Clinical Research Facility: Leeds, St James’s University Hospital. Since joining the NIHR Clinical Research Facility: Leeds at St James’s University Hospital, Lorna Gallacher has quickly established herself within the dynamic and highly specialised field of early phase oncology research.

Working in first-in-human clinical trials, Lorna supports patients with complex and hard-to-treat cancers, helping to deliver innovative treatments at the earliest stage of clinical development. Her role places her at the forefront of research, where new therapies are tested for the first time in patients, offering hope and new possibilities where treatment options may be limited. 

Demonstrating strong commitment and dedication, Lorna achieved chemotherapy competency within just four months of joining the team — a significant milestone that reflects both her clinical expertise and adaptability in a fast-paced research environment. 

Lorna’s career continues to evolve, with a growing focus on haematology research, particularly in myeloma. This progression highlights the breadth of opportunities within research nursing and the ability to develop specialist knowledge across different clinical areas. 

Alongside her clinical role, Lorna is passionate about supporting the wellbeing of her colleagues. She has begun training as a Professional Nurse Advocate (PNA) at De Montfort University, where she is developing skills to provide Restorative Clinical Supervision (RCS) — helping nurses reflect, recover and sustain their wellbeing in demanding healthcare settings. She has also been accepted to train as a Mental Health First Aider (MHFA), further strengthening her ability to support a positive and healthy working environment. 

Reflecting on her experience, Lorna highlights the exciting and rewarding nature of her work: 
“Being part of early phase oncology research means I’m supporting patients at a time when treatment options may be limited, and that’s incredibly meaningful. It’s inspiring to be involved in innovative research, such as advanced therapies, that have the potential to change lives. At the same time, I’m passionate about supporting my colleagues’ wellbeing, because a strong, supported team is essential to delivering the best care for our patients.” 

Through her work, Lorna is contributing to life-changing research, including involvement in advanced therapies such as Advanced Therapy Medicinal Products (ATMPs), while also supporting both patients and colleagues — a powerful example of the impact of research nursing within the NHS. 

NIHR Clinical Research Facility Leeds showcases 20 years of research impact at International Clinical Trials Day

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International Clinical Trials Day

The NIHR Clinical Research Facility Leeds were proud to take part in the International Clinical Trials Day celebration at the NIHR Biomedical Research Centre (BRC) Leeds, joining colleagues, patients, and partners for a day dedicated to recognising the impact of health research. 

As part of the programme, the team delivered a presentation highlighting the work of the Clinical Research Facility and the significant advancements made over the past 20 years. The session offered an overview of how the facility supports the delivery of early-phase and experimental medicine studies, helping to translate innovative research into real improvements in patient care. 

Alongside this, the team hosted a Patient and Public Involvement, Engagement and Participation (PPIEP) stand, creating an open and welcoming space for patients, staff, and visitors to learn more about clinical research. Attendees had the opportunity to speak directly with the team, ask questions, and explore how they can get involved in shaping and participating in research. 

Through both the presentation and interactive stand, the Clinical Research Facility reinforced its commitment to advancing research through collaboration, innovation, and meaningful patient involvement.

World-leading clinical research showcased as Minister pays visit to NIHR Leeds Clinical Research Facility

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An image of key clinical staff and colleagues standing smiling in a line up photo with Karin Smyth MP stood in the centre outside the NIHR Leeds Clinical Research Facility St James site.

World-leading clinical research and pioneering cancer treatment taking place in Leeds has been showcased as part of the Government’s national cancer plan roll out.  We recently welcomed Karin Smyth, Minister of State for Health to St James’s University Hospital to see first-hand the cutting edge cancer trials and the innovative treatment which is being pioneered. 

An image of Professor Chris Twelves speaking with minister Karin Smyth MP in a clinical room.

The Minister had the opportunity to meet with Prof Chris Twelves, Professor of Clinical Cancer Pharmacology & Oncology and Clinical Director NIHR Leeds Clinical Research Facility alongside clinical research colleagues, senior clinicians and experts and partners of Leeds Teaching Hospitals who work collaboratively to deliver world-class cancer treatment to patients across Yorkshire.    

Ms Smyth heard about the diverse and expansive portfolio of clinical research, particularly rare cancers including anal cancer, myeloma and sarcoma, while visiting the state-of-the-art NIHR Leeds Clinical Research Facility based at the hospital.  It was the opportunity for us to share the world-leading, early-phase, experimental medicine studies taking place right here which aim to develop new treatments and healthcare therapies for the future.  

Prof Chris Twelves said: 

“We were delighted to welcome Minister Smyth to NIHR Leeds CRF recently.  It was an opportunity to demonstrate our impressive track record of delivering early phase experimental medicine trials and evaluating a range of new therapies and interventions.   Leeds St James’s CRF is just one of our five clinical research facilities co-located at Leeds Teaching Hospitals NHS Trust  and it was a privilege for our team and I to talk about how we support world-class research here.”

An image of minister Karin Smyth MP with a health care professional standing talking in a hospital corridor.

The Minister also spent time in Leeds Cancer Centre, one of the most comprehensive cancer centres in the UK and home to the largest single-site radiotherapy treatment service.  It was the opportunity to shine a light on the advances in treatment of anal cancer using precision radiotherapy, which has been pioneered following research by Prof David Sebag-Montefiore, Professor of Clinical Oncology at University of Leeds and funded by Cancer Research UK.     We were delighted to share the breadth and depth of clinical research we do right here in Leeds and demonstrate the impact we’re having on our patients today and the healthcare of tomorrow.

Advanced Therapies at the NIHR Leeds Clinical Research Facility (CRF)

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A picture of Professor Chris Twelves.

The NIHR Leeds Clinical Research Facility is helping to shape the future of healthcare. In this blog post, Prof Chris Twelves, Clinical Director at the CRF, outlines what advanced therapies are, why they matter, and how the CRF is supporting their safe and effective development for patients.

What are Advanced Therapies?

Advanced therapies or Advanced Therapies Medicinal Products (ATMPs) are umbrella terms describing treatments that work at the level of cells, tissues, or genetic material. These therapies can offer long-lasting benefits and in some cases, the potential for cure. They are already showing important benefits in people with blood cancers, but are now reaching into other areas.

“Advanced therapies represent some of the most innovative areas of modern medicine. They aim to repair, replace, or restore biological function in ways that were previously impossible. At the CRF we are supporting the development and delivery of these cutting-edge approaches to improve patient outcomes.”

Advanced therapies include:

  • Cell therapies: using living cells to prevent, treat, or cure disease
  • Gene therapies: introducing or modifying genes to address underlying causes of illness
  • Tissue-engineered therapies: using engineered tissues to repair or replace damaged structures
  • Combined or next-generation approaches: including engineered immune cells, cancer-targeting viruses, and virus-based vaccine platforms

These approaches are increasingly used to treat cancers, inherited diseases, immune disorders and other hard-to-treat conditions.

Advanced Therapy research

The CRF supports early-phase clinical trials involving advanced therapies and ATMPs. Working with colleagues, our specialist teams provide the facilities, governance and expertise to support safe delivery of complex studies.

We support ATMP trials including those involving CAR-T cell therapies and oncolytic viruses.

Extending the impact and reach of CAR-T cell therapies

In haematology, Dr Frances Seymour is leading clinical trials of CAR-T cells in multiple myeloma and Dr Jonathan Carmichael is working closely with Professor Francesco Del Galdo and the rheumatology team investigating novel immunotherapies in treating autoimmune diseases. This work is further strengthened by Hannah Newman, Lead Nurse for the St James’s University Hospital CRF, who brings extensive experience in haematology clinical trials.

Leading centre for oncolytic virus research

Over many years Leeds has played a major role in advancing oncolytic virus therapy. In trials we have given oncolytic viruses directly into tumours or intravenously, in patients with a range of different cancers and the virus given either alone or in combination with other ant-cancer treatments. Working with Prof Adel Samson, clinical and scientific partners, and commercial sponsors the CRF has supported studies that have helped shape the field.

“Key achievements include demonstrating that oncolytic viruses can be delivered intravenously, showing benefits when combined with immunotherapies and supporting studies that have produced durable tumour responses in melanoma and liver cancer.”

Our commitment

“Advanced therapies offer new hope for people with conditions that are difficult to treat. At the NIHR Leeds CRF, we are committed to accelerating the safe development of these life-changing innovations.”

Research nurse makes dream come true for Leeds United supporting CRF trial patient

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An image of a man standing on the pitch at a football ground smiling a giving two thumbs up to camera.

Senior Haematology research nurse Keri Barker-McDonald recently went the extra mile for one of her clinical trial patients by arranging a personal tour of his favourite football club.

Mark Storey, 61, who has graft-versus-host disease (GVHD) is participating in a clinical trial hosted by NIHR Leeds CRF exploring new therapies for the condition and has been attending the clinic regularly since September. 

Mark is a lifelong fan of Leeds United football club but has been unable to attend matches for the past few years following his illness. Keri has been treating Mark on the trial and wanted to help him celebrate one of his biggest passions.

Keri said: “One day I was having a conversation with Mark during his weekly visits for the trial. We were talking about Leeds United as we are both big fans, and how he can’t get to matches anymore. I just went home and I was thinking how sad it was. So, I contacted Leeds United’s patient liaison officer to see if we could arrange something for him”.

An image of a man standing with thumbs up next to a wall with the Leeds United Football Club team logo and Golden text next to it reading "Welcome To Leeds United Football Club"
An image of a person giving the thumbs up in a corridor with Leeds United Football Club imagery and symbolism on the walls behind him to his left and right,

“I was surprised to hear that they were more than willing for Mark to have a day out at the stadium and they’ve been fantastic in supporting him visiting Elland Road Stadium. When I told Mark what I’d arranged, he was over the moon.”

Mark shared: “I’ve been receiving excellent care as part of the clinical trial I’m taking part in and have really got to know Keri. We’ve shared lots of stories about Leeds United and I was absolutely thrilled with the personal tour of the stadium she arranged for me. I spent the day there and managed to see the teams’ dressing rooms, had a personal tour of the grounds and the hallowed pitch itself. As a Leeds United fan, it was really a dream come true and I can’t thank Keri enough.”

We are proud of Keri’s commitment to care that reflects the very best of our values that we strive for as a research facility, focussed on supporting patients’ needs both clinical and personal.