Extracorporeal Photopheresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Lung transplantation offers hope to people with life-threatening lung disease. Sadly, many transplanted lungs do not maintain normal function after transplant due to damage inflicted by the recipient’s own immune system. This loss of function is known as chronic lung allograft dysfunction (CLAD). CLAD affects half of all recipients within 5 years, meaning average survival after lung transplant is only 6 years. There is an urgent need for treatments that stop CLAD early to protect lung function, preserve quality of life and prolong survival.
Extracorporeal photopheresis (ECP) uses a machine to separate blood outside the body into white (immune) cells and red cells. The white cells are shut down with light treatment. Both the white and red blood cells are then returned to the patient. The treated white cells reprogram the immune system to stop further damage. ECP is routinely used to treat complications after bone marrow transplant.
Some studies using ECP to treat CLAD have shown promise at slowing progression. These studies were done in single hospitals in selected patients and without comparison to those not getting ECP, so there is insufficient evidence that ECP is effective in treating CLAD for the NHS to use it routinely. Our aim is to assess if ECP is effective at treating CLAD. Our trial, which will run in all 5 UK adult lung transplant centres, will recruit 90 patients with CLAD. These patients will be randomly allocated to receive either ECP and standard care or standard care alone for 6 months. We will test if adding ECP treatment to current care is more effective at stabilising transplant lung function than standard care alone. We aim to understand how ECP works in CLAD, which patients are most likely to benefit, and ultimately help the NHS decide if ECP should be used to treat CLAD.
East Midlands - Derby Research Ethics Committee
Date of REC Opinion
17 Oct 2022
Further Information Favourable Opinion