Published: 18 September 2020
Find out more about the REALIST trial on the study's webpage.
A world-leading UK-wide trial supported by NIHR is offering a pioneering cell therapy treatment for patients with acute respiratory failure caused by COVID-19.
The groundbreaking study, led by experts at Queen’s University Belfast, is the first of its kind in the UK investigating if allogenic Mesenchymal Stromal Cells (MSCs) can be used to treat patients with Acute Respiratory Distress Syndrome (ARDS).
The trial is one of a number of COVID-19 studies that are considered to be urgent public health research by the UK’s Chief Medical Officers.
Many of the most critically unwell patients with the virus develop ARDS - a condition where the lungs become inflamed and leaky so they fill with fluid. This causes respiratory failure and patients may require admission to intensive care and a ventilator machine to support their breathing.
Researchers on this trial will use MSCs - a type of cell derived from human tissue such as bone marrow or umbilical cord (which is otherwise discarded after the baby is born) - to treat the damage to the lungs caused by the virus. It is hoped the cells will reduce inflammation and improve lung repair, thus leading to improved outcomes for patients.
The Phase II clinical trial, funded by the Wellcome Trust and the Health and Social Care Research & Development Division Northern Ireland, has been given priority status through the NIHR’s national prioritisation process on behalf of the Department of Health and Social Care. It is sponsored by the Belfast Health and Social Care Trust and supported by the NIHR Clinical Research Network (CRN).
Patients will be treated with a purified population of MSCs derived from umbilical cord tissue, called ORBCEL-C - a therapy that has been developed by scientists at Orbsen Therapeutics in Galway, Ireland. The ORBCEL-C therapeutic is manufactured under licence by the UK NHS Blood and Transplant Service for the trial.
MSCs are a novel treatment that have been shown in experimental models to reduce inflammation, fight infection and improve the repair of injured tissue.
The trial is being introduced as part of an existing programme of research investigating the use of MSCs in patients with ARDS. The researchers have now completed the recruitment of 60 patients, recruited through multiple sites across the UK.
It is led by Professors Danny McAuley and Cecilia O’Kane, both from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s.
Professor McAuley is also part of an international network of researchers who are taking forward trials of umbilical cord-derived MSCs for the treatment of COVID-19.
The study is also supported by the NI Clinical Trials Unit and the Northern Ireland Clinical Research Network.
Professor Danny McAuley, Co-Chief Investigator, based at Queen’s University Belfast, said: “This trial is the first of its kind in the UK to test if cell therapy as a novel treatment for severe respiratory failure due to COVID-19 is safe and associated with improvement in patient outcomes. There is an urgent need for evidence in this area and we hope our research provides important insight into this innovative treatment.”
Professor Cecilia O’Kane, Co-Chief Investigator, based at Queen’s University Belfast, said: “It is only through clinical trials we will be able to determine if new treatments are effective and safe in critically ill patients.”
Professor Nick Lemoine, Medical Director of the NIHR Clinical Research Network (CRN), said: “This is a pioneering, world-leading trial using a cutting edge intervention that could make a huge difference to some of the most severely ill patients with COVID-19 and hopefully provide lifesaving treatment.”
Orbsen CSO Steve Elliman said: “While there are over 100 vaccines and therapies in development targeting the SARS-CoV-2 infection - at present there are no disease modifying therapies approved for ARDS. We’re delighted the REALIST trial was approved and listed by NIHR as an Urgent Public Health Research Study so we can continue assessing the safety of the ORBCEL-C therapy in patients with ARDS.”
For more information on the study:
- Discover more about the launch of the REALIST COVID-19 trial.
- Research delivery staff explain what life is like working on the trial in our #Covid19ResearchVoices blog series.
- A summary of the REALIST COVID-19 study is available on the NIHR website.
- Find out more about the trial on the REALIST COVID-19 webpage on the Northern Ireland Clinical Trials Unit website.