As part of the UK response to the COVID-19 pandemic, the Wellcome Trust funded REALIST clinical trial is assessing a novel allogeneic stromal cell therapy in a Phase 2 trial targeting Acute Respiratory Distress Syndrome (ARDS) caused by COVID19.
Recent reports indicate that 80-90% of COVID19-realted deaths are caused by ARDS and ICU patients with moderate-severe ARDS caused by COVID19 have a 28-day mortality rate of ~50%.
There are currently a significant number of vaccines and therapies in development for targeting the SARS-CoV-2 infection. All of these treatments are targeting the virus and its ability to infect and replicate within the body. However, few therapies are in development to address ARDS.
REALIST is a 1:1 randomised, Phase 2, placebo-controlled, double blind study assessing the ORBCEL-C stromal cell immunotherapy in 60 patients with moderate-severe ARDS caused by COVD19. The REALIST open label Phase 1 safety trial was successfully completed in 2019.
The REALIST trial is led by Professor Danny McAuley and Professor Cecilia O’Kane at Queens University Belfast and was approved and listed by UK NIHR as an Urgent Public Health Research Study. REALIST is already enrolling patients and plans to recruit at least 60 patients throughout the Covid-19 pandemic at multiple sites across the UK, including Belfast, Birmingham and London.
ORBCEL-C is an antibody purified allogeneic stromal cell therapy selected from umbilical cord tissues developed by Orbsen Therapeutics. Orbsen are a partner in the Midlands and Wales Advanced Therapy Treatment Centre (ATTC) programme. Building on their existing relationship formed as a part of this consortium, Orbsen are manufacturing ORBCEL-C at the University of Birmingham Advanced Therapies Facility (ATF).
The ATTC Network Programme is being developed to enable the adoption of complex and effective cell and gene into the NHS. The ATTC programme is supporting the development safely transported, tracked and delivered ATMPs to every NHS Trust in the UK as well as the necessary governance and infrastructure required. The ATTC Network is funded by Innovate UK and coordinated by the Cell and Gene Therapy Catapult, to address the unique and complex challenges of bringing pioneering advanced therapies like ORBCEL to NHS patients.
For further details on all the trails currently being priorities nationally please see the NIHR pages linked here