Published: 15 April 2024
Researchers are investigating if skin patches can be used as an 'early warning system' to identify lung transplant rejection. This is so treatment can begin sooner, reducing the chance of longer lasting organ damage.
NIHR and the Medical Research Council (MRC) are funding the trial. An Oxford University team is leading the study, together with 5 UK lung transplant centres and NHS Blood and Transplant.
Organ rejection may show as a rash on the donated skin patch, often before the body has started to reject the lungs. If such a rash appears, a tiny biopsy from the skin will be taken to confirm the presence of rejection.
If the trial is a success, and the approach can be rolled out to all lung transplant recipients, the research team believe it could cut rejection by up to 50%.
The SENTINEL trial started this month and will recruit 152 patients over 3 years. Oxford University's Surgical Intervention Trials Unit is running the trial.
Patients will receive a 10 x 3cm skin patch from the forearm of the organ donor. It will be transplanted onto the under-surface of the patient’s forearm at the same time as the lung transplant. The skin transplant will be carried out by an independent plastic surgeon.
Skin seems to reject earlier than other organs and is easily visible at all times. Doctors can treat the rejection as soon as a rash appears, to try to prevent the lung from also rejecting.
Lung transplant rejection rates are high and cause injury. Around 55% of patients are alive after 5 years. Rejection is monitored through tests of lung function, blood tests, X-rays and lung biopsies. But it’s difficult to identify until it is already quite advanced.
Identifying early signs of rejection allows earlier and more personalised treatment. This helps the organ to work for longer. If there are no signs of rejection, immunosuppressant medication can be reduced. This minimises side effects including higher risks of cancer and diabetes.
The transplants will be carried out by the lung transplants teams at specialist Cardiothoracic Centres across England. Donor families will need to give consent for the skin transplant to take place, which will be requested by NHS Blood and Transplant nurses.
Sentinel skin grafts have previously been used in studies where patients received intestinal transplants. Experts observed that patients who received a skin patch experienced a much lower rate of organ rejection – around half of what would be expected. This suggests the patch helped to prevent rejection as well as being a useful monitor of early rejection.
Chief Investigator, Henk Giele, Associate Professor of Plastic, Reconstructive, Transplant and Hand Surgery at University of Oxford, said: “Lungs are prone to rejection due to their exposure to outside air and high propensity to infection. It is often difficult to know if a reaction is caused by infection or rejection as they look the same at the early stages, but the treatments for each are completely opposite. It’s for this reason that we have focused the SENTINEL trial on the lungs – a visible warning system like this is crucial for all transplants, but especially those with higher rejection rates.”
Fiona Ballantyne, 56, from Falkirk, is on the waiting list for a lung transplant after being diagnosed with Pulmonary Arterial Hypertension in 2019. She has applied to be a part of the SENTINEL trial, and said: “The opportunity to potentially be able to see if your organ is rejecting just by looking at your arm is huge for those of us who are facing transplants. Not only because of the fact we could receive treatment earlier than if we didn’t have the patch but also for the peace of mind it would offer, being able to consult the skin patch whenever we feel under the weather.
“I’m proud to have applied to be a part of the SENTINEL trial – if it does go on to be successful, it would be a momentous moment for transplant recipients, that wouldn’t be possible without donors. I would strongly urge everybody to make their wishes around donation known to their significant others.”
Adam Alderson, 44, from Wensleydale, received a skin graft for multi-organ transplant in 2015, which helped identify signs of rejection. He said the trial is “really exciting”, and added: “My abdominal wall graft has shown rejection three times, allowing it to be quickly treated. It’s a really comforting thing to have – I feel safer knowing that I have a tool available to tell if something is going wrong before it becomes too serious. It’s almost like an oil warning light on your car. Plus, having that visible reminder of how lucky I am is really special.”
Health Minister Andrea Leadsom, said: “This trial offers hope to lung transplant patients across the country. Early detection of organ rejection means a healthier transplant, giving people greater control of their care and speeding up access to treatment.
“We are committed to funding innovative research like this through NIHR, which will help us revolutionise transplants, minimise side effects, and ultimately save lives.”
The study is funded by the Efficacy and Mechanism (EME) Evaluation Programme - an NIHR and MRC partnership. NIHR’s Clinical Research Network (CRN) is supporting the study.