In the most critically unwell patients with COVID-19, many develop a complication known as 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.
A recent statement from the four UK Chief Medical Officers outlined the importance of clinical trials amidst the COVID-19 crisis. Professor Cecilia O’Kane said:
““It is only through clinical trials we will be able to determine if new treatments are effective and safe in critically ill patients.”
Using human tissue cells to treat lung injury from COVID-19
The trial involves the use of 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 lung caused by COVID 19. MSCs are a novel treatment that have been shown in experimental models to reduce inflammation, fight infection and improve the repair of injured tissue.
Patients in this trial, which is known as REALIST COVID 19, will be treated with a purified population of MSCs derived from umbilical cord tissue called ORBCEL-C. The ORBCEL-C therapy 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 REALIST COVID-19 trial.
The trial is being introduced as part of an existing programme of research investigating the use of MSCs in patients with ARDS. The first patient has now been recruited with plans to recruit at least 60 patients throughout the COVID-19 pandemic at multiple sites across the UK including Belfast, Birmingham and London.
Professor Ian Young, Clinical Professor at the Centre for Public Health, Queen’s University Belfast, Director of HSC R&D and Chief Scientific Advisor at the Department of Health, said:
““The Health and Social Care Research & Development Division has been working with researchers across HSC to address the global problem of Coronavirus. We have contributed £230K for this vital research which will provide important evidence regarding a potential new treatment for respiratory failure, a leading cause of mortality in COVID-19. We 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 help tackle the spread of COVID-19.”
Study given urgent public health research status
The trial has been identified by the National Institute for Health Research (NIHR) as a national urgent public health study. It 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. The study is funded by the Health and Social Care Research & Development Division and the Wellcome Trust, sponsored by the Belfast Health and Social Care Trust and supported by the NI Clinical Trials Unit, the NIHR Clinical Research Network and the Northern Ireland Clinical Research Network.
Orbsen CSO Steve Elliman noted:
““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 assess the safety of the ORBCEL-C therapy in patients with ARDS.”
Sir Professor Alimuddin Zumla of University College London, a global coronavirus and infectious diseases expert 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.”
Professor Danny McAuley is also part of an international network of researchers who are taking forward trials of umbilical cord-derived Mesenchymal stromal cells for the treatment of COVID-19: UK: (UCL- Sir Professor Azumla); Portugal (Champualimud Foundation - Professor Markus Maurer; Italy (INMI-Professor Giuseppe Ippolito) and China (Fifth Medical Center- Professor Fu-Sheng Wang.)