Repair of ARDS by Stromal Cell Administration (REALIST) [COVID-19] [UPH]
Research type
Research Study
Full title
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.
IRAS ID
227090
Contact name
Danny McAuley
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Eudract number
2017-000584-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 31 days
Research summary
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. [COVID-19 amendment - 30/03/2020]
REC name
North East - York Research Ethics Committee
REC reference
18/NE/0006
Date of REC Opinion
6 Feb 2018
REC opinion
Further Information Favourable Opinion