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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. 

Collaboration at PPI Community Connect 2025 sets direction for more representative research

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A group photo of the PPIE team with the hosts for the event at the Hamara Centre, in front of a stylish neon sign that reads 'HAMARA'.

Our recent Patient Public Involvement (PPI) event was held recently at the Hamara Healthy Living Centre. The PPI Community Connect 2025 event brought together over 86 community members, along with researchers. The event was designed to explore how research can be more meaningful, representative, and inclusive, providing opportunities to share experiences, learn about ongoing studies, and discuss ways to strengthen engagement across diverse communities.

Hosted by the NIHR Leeds Clinical Research Faculty (CRF) and Leeds Teaching Hospitals (LTHT) Research & Innovation department and taking place at the Hamara Healthy Living Centre in Leeds, the event brought together participants who shared experiences and ideas on improving public involvement in research.

The audience heard presentations from researchers outlining current projects, alongside personal stories from patients describing what taking part in research has meant to them.

Guests were welcomed by Dr Helen Radford, Lead for Strategic Leadership at NIHR UK CRF Network and Associate Director of Operations for LTHT Research, and Hanif Ismael, Lead for Patient Public Involvement at NIHR Leeds CRF.

An image of two volunteers with a staff member demonstrating the ECHO cardiac ultrasound machine on a volunteer in the background.

The event showcased a range of ongoing research in Leeds, covering prostate cancer, knee replacement, early detection of lung cancer, and heart health. Alongside these presentations, attendees also had the opportunity to take part in hands-on activities, including an ECHO heart scan demonstration (pictured above), which helped people better understand how research links to real clinical practice.

Contributors, Graham Holland and Imtiaz Chaudary, reflected on their own involvement in research and highlighted the importance of inclusive research.

Attendees also took part in group discussions that explored ways to strengthen engagement, widen participation among under-represented communities, and shape future research priorities.

The conversations touched on topics such as including more community-based sessions, improved multilingual materials, better use of digital and media channels, engaging people at cultural events and public spaces, providing appropriate language support, involving healthcare teams, and offering suitable incentives. and generated suggestions that will inform future initiatives.

Feedback from participants indicated that the event provided a valuable opportunity to ask questions, share experiences, and think about how research and communities can work better together.

One attendee described the day as “Well run, well attended, interactive and informative”, while another said it “was useful and made me willing to engage in research and share the opportunities.”

The organisers plan to use insights from PPI Community Connect 2025 to guide ongoing work on improving patient and public involvement.

For more information, please contact [email protected].

Leeds heads multi-centre trial of innovative treatment for childhood Duchenne muscular dystrophy

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An image of Edward with the care team at the NIHR Leeds CRF Children's site.

The NIHR Clinical Research Facility is playing a key role in a trial exploring a new treatment for children with Duchenne muscular dystrophy, a rare and progressive muscle-wasting condition.

The GUARDIAN trial, which is being run through NIHR Clinical Research Facility at Leeds Children’s Hospital, is evaluating the long-term use of vamorolone in Duchenne muscular dystrophy (DMD).

DMD is a genetic condition that usually affects boys. It causes progressive muscle weakness, with restricted mobility and a shorter life expectancy.

The newly approved treatment, vamorolone aims to help children with DMD maintain muscle strength for longer, whilst reducing some of the most difficult side effects associated with existing medications.

Current recommendations for care include use of anti-inflammatory drugs that supress a patient’s immune system, called corticosteroids. They can delay disease progression but often lead to stunted growth, emotional and behavioural challenges, and other quality-of-life issues that can be difficult to manage at home and at school.

Vamorolone is an alternative corticosteroid recently approved by the National Institute for Health and Care Excellence (NICE). In short term studies, it appears to offer the same benefits as current treatments, slowing decline in motor function but with fewer side effects related to growth, mood, and behaviour.

Dr Anne-Marie Childs, Consultant Paediatric Neurologist and Chief Investigator for GUARDIAN, said: “Having been one of the UK sites to take part in the original clinical trial of vamorolone (the Vision DMD study) we are pleased to see that vamorolone will be available for use in NHS care from April 2025. However, as with all new drugs there are many ‘unknowns’ with vamorolone’s use in clinical practice.

It is, therefore, essential to gather further data on its longer-term effectiveness and side effects which is why the GUARDIAN study is so important for both the UK and the international DMD community. We are delighted to be at the forefront of this work, as chief investigating UK site and the first to recruit to the study.” 

David Taylor and Rachel Allen’s son, Edward, aged 9, is taking part in the study. Living in Northallerton, North Yorkshire, Edward uses a powered chair daily to get to school and go on trips with friends and family due to his limited mobility.

“Our experience of being on a clinical trial has been fantastic. Regular check-ups with a kind and friendly team are great and he is being cared for brilliantly. It is amazing to think that being on a clinical trial allows Edward to help others in the same position in the future.”

David and Rachel said: “By using the powered chair, Edward then has the energy to use play equipment such as swings and slides – something which he loves. Edward is a remarkable, wonderful boy. In daily life we try to ensure that Duchenne does not ‘rule the roost’.”

They added: “Our experience of being on a clinical trial has been fantastic. Regular check-ups with a kind and friendly team are great and he is being cared for brilliantly. It is amazing to think that being on a clinical trial allows Edward to help others in the same position in the future.”

“The staff at Leeds are amazing and they go out of their way to ensure you receive the best care possible. We are really fortunate to live near such a great centre for research!”

Research experience helps Leeds Young Owls Take flight into medicine

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An image showing people conducting desk research.

Two members of our young research group, the Leeds Young Research Owls have been successfully accepted into universities to study medicine and train to be doctors.

The Leeds Young Research Owls (LYRO) group, funded by NIHR Clinical Research Facility, aims to inspire the next generation of researchers by providing young people with opportunities to learn about the medical research process through the Trust’s extensive research portfolio.

This provides a way to reach younger people and inspire them to become involved and engage with medical science and clinical research, preparing the next generation of researchers.

An image of LYRO alumni, Henry, who has been accepted to medical school. The images is a selfie of Henry standing outside on a track by a field at sunset.
Henry credits his experience with LYRO in getting into medical school

Owls alumni Oliver Barrie and Henry Neligan have both gained places at medical school, a remarkable achievement that reflects their dedication and the valuable experience gained through the group.

Henry (pictured), who is now studying at Newcastle University said: “The Owls and the medical research we took part in was a piece of my inspiration to become a doctor.  I am just so grateful for all the help the Owls has given me!”

Oliver, who is attending Hull York Medical School, added: “I included some of my experiences with LYRO on my personal statement and I also discussed the brilliant insight it gave me into medicine as a whole, and medical research at my interviews. Without the meetings with the Owls, I wouldn’t have had the unique experiences to talk about throughout my application process.”

LYRO now has a proven track record of helping foster the clinicians of the future, with five previous members successfully accepted to medical school to train as doctors.

With a growing legacy of success, LYRO continues to empower young people to pursue careers in medicine and research, fostering the skills and experiences that help shape the future of healthcare. We are incredibly proud of Oliver, Henry, and all our alumni who are making a difference in the medical field.

Leeds NIHR Clinical Research Facility supporting expanded plan for patient enrolment in head and neck cancer vaccines trial

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An image of the senior members of the Leeds CRF stood by the entrance to one of the units in front of a NIHR Leeds CRF banner.

The NIHR Leeds Clinical Research Facility (CRF) is supporting Leeds Teaching Hospitals NHS Trust (LTHT) as part of an expanded fast-track pathway for head and neck cancer patients into a national clinical study of mRNA-based cancer vaccines for head and neck cancer, announced by NHS England.

LTHT is one of 15 NHS sites selected to offer participation in the trial, known as AHEAD-MERIT (BNT113-01), as part of NHS England’s Cancer Vaccine Launch Pad (CVLP), a national programme coordinated by the Southampton Clinical Trials Unit.

The CVLP scheme is designed to enable faster identification and referral for eligible patients to studies investigating mRNA cancer vaccines.

NHS England is working in partnership with BioNTech as part of the trial, which focuses on research into vaccines that aim to stimulate immune responses against cancers associated with human papillomavirus (HPV-16).

The Leeds CRF is supporting local delivery of the AHEAD-MERIT study, providing research infrastructure for clinical assessments and procedures. The facility has previously been involved in supporting referrals to the CVLP for other studies involving bowel cancer.

NIHR Leeds CRF supports new study into Penicillin allergy testing to fight antibiotic resistance  

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An image of a person holding white tablets in their left hand

A trial supported by NIHR Leeds CRF into removing incorrect penicillin allergy labels on GP records could combat antibiotic resistance and save lives, an NIHR-funded clinical trial led by the University of Leeds has found. 

Penicillins are first-choice antibiotics for many common infections, but more than one in 15 UK adults have a penicillin allergy label on their medical records. In the event of an infection, they will be prescribed alternative antibiotics which can be less effective or have more side effects. This can result in several prescriptions being issued to control the infection, which affects wellbeing and contributes to antimicrobial resistance.  

The study published in the Lancet Primary Care, which was supported by NIHR Leeds Clinical Research Facility in Leeds, found that that almost nine in ten (88%) patients with a penicillin allergy label were not truly allergic after testing, and had their allergy label safely removed. More than 800 patients were included in the trial. 

Verifying the accuracy of penicillin allergy labels could help patients to access more effective antibiotics, which is crucial as the threat of antimicrobial resistance to public health grows. The ALABAMA (ALlergy AntiBiotics And Microbial resistAnce) trial, coordinated by the University of Oxford Primary Care Clinical Trials Unit, was created to help find solutions for this issue.  

An image of Dr Jonathan Sandoe
Dr Jonathan Sandoe was joint lead author on the ALABAMA study

Joint lead author Dr Jonathan Sandoe, Associate Clinical Professor in Microbiology in the University of Leeds School of Medicine and Leeds Teaching Hospitals NHS Trust, said: “Antibiotics have been life-saving drugs since the late 1930s, but we are now in an era where microbes are evolving to resist the effects of current antibiotics. The global challenge of antibiotic resistance is causing people to die of common infections – so it is vital to find ways to improve how antibiotics are used. Assessing people with penicillin allergy labels is one way we can achieve this.” 

Read the full story via the University of Leeds website 

Charity partnership backs neuromuscular research powered by NIHR Leeds CRF, enabling life-changing trials for families

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An image of Austin in a hospital bed with him mother Maxine and Dr Anne-Marie Childs sitting at the side of the bed.

Duchenne UK and Leeds Hospitals Charity have partnered to fund two new roles within the Neuromuscular Service over the next five years. Together, they are contributing more than £300,000 to support this specialist team, recognising its status as a centre of excellence in paediatric neuromuscular research.

As part of the service, NIHR Leeds Clinical Research Facility (CRF) Children’s Site delivers pioneering clinical trials, exploring innovative treatments for neuromuscular conditions at Leeds Children’s Hospital and has consistently led the way in this area of research.

The NIHR Leeds CRF has been the first site in the UK to recruit to several clinical studies for Duchenne muscular dystrophy (DMD), the most common and severe form of childhood muscular dystrophy. Most recently, the children’s research unit delivered a landmark Phase 1 trial investigating a promising new treatment for DMD.

11-year-old Austin was diagnosed with the condition in November 2015, at just two years old. Austin’s mother Maxine initially thought he had a virus and took him to hospital, where he spent the next month having tests.

Three years ago, Austin began a trial at the NIHR Clinical Research Facility Children’s Site. Austin has received over 130 infusions, and though he knows he will lose the ability to walk, he tells Maxine he takes part in the trials because, ‘I want to help boys in the future to walk longer.’

For Austin’s family, the opportunity to participate in clinical trials has been a lifeline, offering hope to other families to find better treatments and eventually a cure. Austin’s current trial ends in September, but Maxine says if he chooses to continue to take part in research trials, they will continue to visit hospitals up and down the country.

‘From the moment Austin was diagnosed, our world changed. Nothing could have prepared me for the grief of knowing his life would be cut short. But through the darkness, clinical trials gave us hope. The support from the team in Leeds has been incredible; they’ve become like family. Research is vital, not just for medical breakthroughs, but for families like ours to feel less alone. Austin is paving the way, and we’re so proud of him.’

The funding from Duchenne UK and Leeds Hospital Charity will go towards funding the role of Consultant Paediatric Neurologist Dr Anne-Marie Childs. Dr Childs said the funding would be enable the service to plan for the future.

‘We’re incredibly grateful to both Leeds Hospitals Charity and Duchenne UK for their grant funding to support the children’s neuromuscular service. This investment will allow us to attract the best people to work in the Leeds neuromuscular team and create new opportunities for clinical trials that can support even more families. Neuromuscular conditions have a devastating impact, not just on the child affected but the whole family; funding like this gives hope that new treatments and new drugs can be developed.’

NIHR Leeds CRF at 20th UKCRF Network Conference

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The NIHR Leeds CRF team standing on the steps at the conference.

NIHR Leeds CRF recently attended the 20th annual UKCRF Network Conference in Birmingham, the first to be held jointly with the NIHR Biomedical Research Centres.

Twenty-three of our team members, representing the broad scope of our work in clinical research, joined hundreds of delegates from across the UK to exchange insights and learn about the latest developments in healthcare research. It was an opportunity to create new connections and emphasised the importance of collaboration in delivering world-class research which is truly impactful.

Team members at the conference dinner.
An image of Karl Ward and Helen Radford giving with Karl Ward speaking at the lectern in front of a slide with research colleagues photographed on it.
Four colleagues standing in front of the conference banner reading "Co-operate to Translate".
The NIHR Leeds CRF team standing on the steps at the conference.

Dr Helen Radford and Karl Ward delivered an outstanding session at the conference on the ever-growing role of artificial intelligence in advancing research. Dr Radford also shared valuable reflections into attracting commercial clinical research, and Karl Ward presented our approach for best practice in training and embedding research within NHS teams.

We were also privileged to hear from our patient and public involvement and engagement (PPIE) Manager Hanif Ismail and patient representative Barrow Sawo, who spoke compellingly about overcoming challenges in public engagement, highlighting inclusive strategies for meaningful collaboration.

The team had a great experience celebrating their successes at the conference, where they not only presented their research to peers but also had the opportunity to meet and exchange ideas with other leaders in clinical research delivery. Our thanks to the organisers, we are already looking forward to next year’s conference!

Natasha Allergy Research Foundation visit to Leeds Children’s Hospital to meet Clinical Research Facility study participants  

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An image from the visit with clinicians and visitors in a ward setting.

On Monday 7 July, Leeds Children’s Hospital and the NIHR Clinical Research Facility (CRF) Children’s Site welcomed visitors from The Natasha Allergy Research Foundation (NARF). Visitors from Natasha’s Foundation and their partner organisations came to see first-hand how The Natasha Clinical Trial is helping allergy patients in Leeds.

Children as young as two are taking part in the £2.7 million Natasha Clinical Trial across nine NHS hospitals including Leeds Children’s Hospital, part of Leeds Teaching Hospitals NHS Trust. The trial aims to demonstrate the effectiveness of commonly available foods to treat peanut or cow’s milk allergies.

The Natasha Clinical Trial, which began in 2023, is a randomised controlled trial – the gold standard in medical research. Before starting the treatment, the children and young people undergo food challenges over two hospital visits to confirm their food allergy diagnosis and make sure they are suitable to have the Oral Immunotherapy Treatment (OIT).

Once enrolled, each patient is given a very small amount of a food to which they are allergic at a dose that is safe for them, which is taken according to a standardised protocol under medical supervision. This may be given either in a hospital clinic or at home with medical support.

An image of the visitors under a sign for the Children's Clinical Research Facility.
The Natasha Allergy Research Foundation (NARF) and their partner organisations came to see first-hand how The Natasha Clinical Trial is helping allergy patients in Leeds.

If they tolerate the food, they then take a daily ‘dose’ of this real food at home, and the amount is gradually increased by the medical team every few weeks while being closely monitored for any adverse effects.

It is hoped that the OIT treatment will mean that patients who had previously suffered anaphylaxis on exposure to products such as peanuts, will now be able to tolerate eating a small amount of the allergen without having a dangerous reaction.  

The study aims to assess the effectiveness of OIT used to train the immune system of children and young people with food allergies to tolerate an allergen. The results and clinical experience gained from the trial will help shape future treatment options for food allergies in the NHS. Results from the trial are expected in 2027.

Visitors from Natasha’s Foundation were given a tour of Leeds Children’s Hospital facilities including the Children’s Allergy Day Unit where patients come for allergy treatments, and the NIHR Leeds Clinical Research Facility Children’s Site where patients come to take part in the study.

The Leeds Children’s Hospital trial is being led by Dr Aida Semic-Jusufagic who said:

‘We’re delighted to welcome visitors from The Natasha Allergy Research Foundation and their supporters today and show them first-hand how their funding is already benefiting our patients here in Leeds. By taking part in this trial, we’re helping to shape the future of the treatment of allergy in the NHS’.   

An image with a Eddie a young patient on the bed with Dr Aida Semic-Jusufagic, sitting at the bed side.
Dr Aida Semic-Jusufagic, lead for the trial, pictured with Eddie a young patient.

The Natasha Clinical Trial is the first major study to be funded by The Natasha Allergy Research Foundation, set up by the parents of Natasha Ednan-Laperouse, who died aged 15 from a severe food allergic reaction.

Visitors spoke to families of patients taking part in The Natasha Clinical Trial in the CRF including parents of 2 year old Iyla who has several food allergies including dairy, egg, nuts, beans and peas. Parents Rachel and Mitesh spoke about how the Iyla’s dietary restrictions affect so many things in her life from child-care and holidays to day-day decisions about where to eat and who to spend time with. Iyla’s parents are delighted she has been given the opportunity to take part in The Natasha Trial.

Visitors from Natasha’s Foundation were joined by representatives from corporate partners Booths, CH&CO, Elior, Greene King and Samworth Brothers.  

Rachel Hodson, Director of Corporate Partnerships and Fundraising at Natasha’s Foundation said:

‘It is great to see first-hand the amazing work going on at Leeds Children’s Hospital and meet some of the participants of The Natasha Clinical Trial and their families. For our partners it was a fantastic opportunity to see how their donations are making a real difference to the lives of people with food allergies.’