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New trial using innovative cell therapy treatment for COVID-19 recruits first patients

 

A new UK-wide clinical trial, offering an innovative cell therapy treatment for COVID-19 patients with acute respiratory failure has recruited its first patients, supported by NIHR. 

The study, led by researchers at Queen’s University Belfast, is investigating the use of allogenic Mesenchymal Stromal Cells (MSCs) in patients with a complication known as Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19.

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 in the REALIST COVID-19 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 injury to the lungs caused by the virus.

The trial is the only cell therapy study currently recruiting in the UK for COVID-19 and is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care. It is supported by the NIHR Clinical Research Network (CRN), funded by the Health and Social Care Research & Development Division Northern Ireland and the Wellcome Trust, and sponsored by the Belfast Health and Social Care Trust. 

Professors Danny McAuley and Cecilia O’Kane, both from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s are leading the study. Professor McAuley 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.”

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.

The trial is being introduced as part of an existing programme of research investigating the use of MSCs in patients with ARDS. A total of 13 patients have now been recruited with plans to recruit at least 60 patients throughout the COVID-19 pandemic at multiple sites across the UK.

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."

Sir Professor Alimuddin Zumla of University College London, a global coronavirus and infectious diseases expert, and an NIHR Senior Investigator, said: “This is an exciting and important trial which targets rectifying the underlying causes of lung damage and has great potential of saving many lives from COVID-19. The team should be congratulated for their leadership of host-directed therapies, a concept which has not yet been explored to its full potential.” 

The study is also supported by the NI Clinical Trials Unit and the Northern Ireland Clinical Research Network.

More information about the study is available on the NIHR website and the study’s project page. The REALIST protocol summary is available online.