Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration" (REALIST) (360G-Wellcome-106939_Z_15_Z)

Dr Cecilia O'Kane, Queen's University Belfast will lead a study to examine the safety and efficacy of a novel umbilical cord-derived, mesenchymal stromal cell (ORBCELC) in patients with moderate to severe ARDS, in a phase 112a rollover design. ARDS is a common condition in the ICU affecting more than 20% ventilated patients, or >20,000 patients per year in the UK. Up to 40% die. Survivors frequently suffer long term disability, both physically and psychologically. There is currently no pharmacological therapy that changes outcome from this condition. In the phase 1 study the maximum dose of ORBCEL-C cells that can be delivered in a single infusion to patients within 72 hours of onset of ARDS will be determined. This dose will then be used in a randomized, double blind placebo controlled phase 2a clinical trial, to test safety and efficacy of ORBCEL-C cells in patients with moderate to severe ARDS." A treatment that improved outcome from ARDS would therefore have huge impact on population health