Queen’s University-led Clinical Trial of Orbsen Therapeutics’ Cell Therapy Completes Recruitment of ICU Patients with COVID-19

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Researchers at Queen’s University Belfast announced the completion of patient recruitment for a clinical trial to assess the safety of an innovative cell therapy developed by Orbsen Therapeutics for COVID-19 patients with acute respiratory failure.

Researchers at Queen’s University Belfast announced the completion of patient recruitment for a clinical trial to assess the safety of an innovative cell therapy developed by Orbsen Therapeutics for COVID-19 patients with acute respiratory failure.

The REALIST COVID-19 clinical trial is a placebo-controlled, randomized, double-blind Phase 2 study led by Professor Danny McCauley and Professor Cecilia O’Kane from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University Belfast. The REALIST COVID-19 clinical trial involves 12 leading Intensive Care Units (ICU) across the United Kingdom. Study results are expected in Q2 2021.

This clinical trial is one of several COVID-19 studies given Urgent Public Health Research status by the Chief Medical Officer/Deputy Chief Medical Officer for England. The trial is funded by the Wellcome Trust and Health and Social Care Research & Development Division, sponsored by the Belfast Health and Social Care Trust and supported by the Northern Ireland Clinical Trials Unit.

Critically ill patients with COVID-19 can develop a complication known as acute respiratory distress syndrome (ARDS). ARDS causes the lungs to become inflamed and fill with fluid. This leads to respiratory failure, which often requires patients to be treated in an ICU and placed on a ventilator machine to support breathing.

The REALIST COVID-19 clinical trial assesses Orbsen’s novel ORBCEL-C cell therapy. ORBCEL-C is a purified allogeneic stromal cell therapy that demonstrates the ability to reduce inflammation and fluid build-up in the infected lungs of experimental ARDS models.

Scientists at Orbsen Therapeutics in Galway, Ireland, developed the ORBCEL-C cell therapy which is manufactured for the REALIST COVID-19 clinical trial by the UK NHS Blood and Transplant Service.

Professor Cecilia O’Kane, Clinical Professor at the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University said: “Laboratory and observational data suggest mesenchymal stromal cells (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 on our pathway to evaluate this potential new treatment.”

Orbsen Chief Scientific Officer Steve Elliman added: “We are pleased to have completed recruitment in this – the first multi-center cell therapy trial in critical care patients in the UK or Ireland. 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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About Queens’ University’s Wellcome-Wolfson Institute For Experimental Medicine
WWIEM at Queens University Belfast is committed to research excellence in experimental medicine by making scientific breakthroughs in the mechanisms of disease, which we translate to innovative therapeutics to improve patient outcomes. WWIEM is an international hub of excellence on critical care, respiratory disease and infectious diseases with a core emphasis on immunology, molecular cell biology and patient-based clinical investigations.

About Orbsen Therapeutics
Orbsen Therapeutics, Ltd. is a leading company in the development of cellular immunotherapies across four immune-mediated inflammatory conditions. Founded in 2006, Orbsen Therapeutics Ltd., is a privately held company led by global leaders in the field of cellular immunotherapy. The company, which spun-out from Ireland’s Regenerative Medicine Institute at the National University of Ireland Galway, has developed proprietary technologies that enables the isolation of a well characterized population of pure stromal cells from human tissues which can be expanded and frozen to generate multiple doses of an “off the shelf” allogenic therapeutic product.

For more information visit http://www.orbsentherapeutics.com

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