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Queen’s University Belfast researchers are conducting a clinical trial of a cell therapy to treat acute respiratory distress syndrome (ARDS) associated with Covid-19 (coronavirus) infection.
The UK-wide study, being led by researchers from the university’s Wellcome-Wolfson Institute for Experimental Medicine, is assessing allogenic mesenchymal stromal cells (MSCs).
ARDS is characterised by inflammation and leakage in the lungs, leading to a build-up of fluid. The condition results in respiratory failure and the need for intensive care, along with a ventilator machine.
MSCs are a new therapy option that demonstrated ability to decrease inflammation, combat infection and improve the repair of injured tissue in experimental models.
Named REALIST Covid 19, the trial will administer participants with purified MSCs obtained from umbilical cord tissue called ORBCEL-C, which is developed by Ireland-based Orbsen Therapeutics.
The ORBCEL-C therapy for the trial is produced under licence by the UK NHS Blood and Transplant Service.
REALIST Covid 19 forms part of an ongoing research programme evaluating MSCs for ARDS. The trial is designed to involve around 60 patients at various UK sites and has enrolled its first participant so far.
The National Institute for Health Research (NIHR) categorised the trial as an urgent public health study.
Orbsen Therapeutics 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 assess the safety of the ORBCEL-C therapy in patients with ARDS.”
The study has funding from the Health and Social Care Research & Development Division and the Wellcome Trust.
It is sponsored by the Belfast Health and Social Care Trust, with support from the NI Clinical Trials Unit, the NIHR Clinical Research Network and the Northern Ireland Clinical Research Network.