Researchers at Queen’s University Belfast have completed recruitment of patients to a UK-wide clinical trial that is assessing the safety of an innovative cell therapy for COVID-19 patients with acute respiratory failure.

The REALIST COVID-19 trial is led by Professor Danny McAuley and Professor Cecilia O’Kane, both researchers from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University.

In the most critically unwell patients with COVID 19, many develop a complication known as Acute Respiratory Distress Syndrome (ARDS). In ARDS 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.

The REALIST COVID-19 clinical trial is assessing the safety and efficacy of a novel ORBCEL-C cell therapy to treat ICU patients with COVID-19. ORBCEL-C is a purified allogeneic stromal cell therapy that demonstrated the ability to reduce inflammation and fluid build-up in the infected lungs of experimental ARDS models. Scientists at Orbsen Therapeutics in Galway developed the ORBCEL-C cell therapy which was manufactured for the REALIST COVID-19 clinical trial by the UK NHS Blood and Transplant Service.

The trial was conducted as part of an existing programme of research investigating the use of MSCs in patients with ARDS. 60 patients have now been recruited at ICU sites across the UK including Belfast, Southampton, Manchester, Liverpool, Sunderland, Birmingham, Edinburgh and London. The results of the trial are expected in early 2021.

Professor Cecilia O’Kane, Clinical Professor at the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University, said: “Laboratory and observational data suggest MSCs may be a powerful strategy to treat our sickest patients with COVID-19, but we can only test this properly with well-conducted clinical trials. Completing recruitment is a huge milestone in our pathway to evaluate this potential new treatment.”

This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Chief Medical Officer/ Deputy Chief Medical Officer for England. It is funded by the Wellcome Trust and the Northern Ireland Health and Social Care Research & Development Division and is sponsored by the Belfast Health and Social Care Trust and supported by the NI Clinical Trials Unit. The delivery of the trial was supported by the NI Clinical Research Network and the National Institute for Health Research (NIHR).

Dr Janice Bailie, Assistant Director of Health and Social Care (HSC) Research & Development Division, Public Health Agency, said: “The Health and Social Care Research & Development Division has been working with researchers across HSC to address the global problem of Coronavirus. I’m pleased to see the Northern Ireland research infrastructure leading on the REALIST study, with NI researchers making a strong contribution to reduce the impact of Coronavirus.

“Although we now have the first vaccines in place, it is still important to develop potential Coronavirus treatments to help tackle the spread of Coronavirus and the findings from the REALIST study will be useful in further informing and helping researchers. HSC R&D will continue to support health research and encourage people to participate in research trials and other studies so patients can get the best possible treatment to address Coronavirus.”

Dr. Steve Elliman, Chief Scientific Officer at Orbsen Therapeutics, said: “We are pleased the team at Queen’s University Belfast have completed recruitment in this – the first UK multicentre cell therapy trial in patients with ARDS. A successful outcome from this trial will be a positive step towards limiting damage caused by ARDS in the COVID-19 pandemic.
“We are humbled to collaborate with the remarkable NHS and ICU teams that have worked tirelessly to deliver these complex clinical trials under such challenging circumstances.”

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