Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration" (REALIST)

A single infusion of stem cells from donated umbilical cords could become the first treatment to save patients dying from acute respiratory distress syndrome (ARDS). ARDS affects over 20,000 ventilated patients in the UK each year, and up to 40% die. Survivors often face lasting physical and psychological disability. No drug currently changes the outcome. Dr Cecilia O’Kane at Queen’s University Belfast is leading a two-phase clinical trial. The first phase determines the maximum safe dose of these cells, called ORBCEL-C, given within 72 hours of ARDS onset. The second phase is a randomised, double-blind, placebo-controlled test of safety and efficacy in patients with moderate to severe ARDS. If the treatment works, it would fill a critical gap in intensive care medicine. ARDS is a common ICU emergency with no pharmacological therapy. A successful cell therapy could reduce deaths, shorten hospital stays, and prevent long-term disability for thousands of patients each year. The impact would be direct and immediate: fewer families losing loved ones to a condition that currently has no medical remedy.