Repair of ARDS by Stromal Cell Administration (REALIST)
Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) trial: An open label dose escalation phase 1 trial followed by a randomised, double-blind, placebo-controlled phase 2 trial.
Funder: Public Health Agency for Northern Ireland; Wellcome Trust
Sponsor: Belfast Health & Social Care Trust
CI: Prof Danny McAuley
Approval Date: 02 April 2020
Acute Respiratory Distress Syndrome (ARDS) is a common complication in critically ill patients with COVID-19 infection. In patients with ARDS the lining of the lung is injured and becomes leaky so the lungs fill with fluid, causing difficulty with their breathing. Patients with this condition may require breathing support on a ventilator machine. There are currently no drugs proven to be beneficial in the treatment for ARDS . Mesenchymal stromal cells (also known as mesenchymal stem cells) are cells taken from bone marrow, fat or umbilical cord and may help the lungs to repair and fight infection. This study (the REALIST trial) will test whether a highly purified preparation of umbilical cord derived Mesenchymal stromal cells (called REALIST ORBCEL-C) can help to treat patients with ARDS caused by COVID-19. The first part of the study was conducted prior to the COVID 19 pandemic. It included 9 patients with ARDS caused by other conditions who received increasing doses of REALIST ORBCEL-C to inform which dose is best. The second part of the study will include patients with ARDS due to COVID 19. It will involve approximately 60 patients who will receive treatment with either REALIST ORBCEL-C or a placebo (with no active ingredient). The study will evaluate the safety of REALIST ORBCEL C in patients with ARDS and will assess whether REALIST ORBCEL-C is an effective treatment in patients with ARDS due to COVID 19.
The aim of this study is to conduct a phase 1 and a phase 2 clinical trial of human umbilical cord derived CD362 enriched Mesenchymal Stem Cells (MSC), (REALIST ORBCEL-C cells), in patients with Acute Respiratory Distress Syndrome (ARDS). The phase 1 trial is an open label dose escalation pilot study in which cohorts of subjects with moderate to severe ARDS will receive increasing doses of a single infusion of REALIST ORBCEL-C in a 3+3 design. The phase 2 study will evaluate safety and efficacy outcomes in patients with ARDS due to COVID-19 who have been administered MSC therapy. Although the primary focus of the phase 2 trial is safety, several outcomes will be evaluated to determine whether treatment with MSCs shows efficacy for important outcomes in patients with ARDS due to COVID-19.
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