As part of the UK response to the COVID-19 pandemic, the Wellcome Trust-funded REALIST COVID-19 clinical trial is assessing a novel allogeneic stromal cell therapy in a Phase 2 trial targeting Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 – as well as non-COVID causes of 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. Reports indicate that 80-90% of COVID-19 related deaths are caused by ARDS and ICU patients with moderate-severe ARDS caused by COVID-19 have a 28-day mortality rate of ~35-40%.
ORBCEL-C is a stromal cell therapy selected from umbilical cord tissues developed by Orbsen Therapeutics. For this current REALIST COVID-19 Phase 2 clinical trial, ATTC partner NHSBT have manufactured ORBCEL-C under licence from Orbsen. Building on their productive collaboration formed in MW-ATTC consortium, Orbsen are currently manufacturing ORBCEL-C at the University of Birmingham Advanced Therapies Facility for the subsequent Phase 2b/3 REALIST clinical trial initiation in Q4 2021. Further information can be found here.