In Acute Respiratory Distress Syndrome (ARDS), the injured lung lining becomes leaky, causing them to fill with fluid. This results in difficulty breathing and patients often require ventilator support. ARDS is common in severely ill patients in Intensive Care Units (ICU) and is associated with mortality rates of up to 40% and high degrees of morbidity in those who survive. ARDS has a significant impact on resources; prolonging ICU and hospital stays and many patients require rehabilitation in the community. Currently, there are no approved treatments for ARDS, thus a suitable intervention would undoubtedly improve the outcomes for ARDS-afflicted patients. Mesenchymal Stromal Cells (MSCs) offer considerable promise as a novel therapeutic strategy for ARDS. Studies have shown that MSCs may show promise in treating other illnesses, and the cells are usually well tolerated by patients. The REALIST trial plans to tests if treatment with a preparation of MSCs – called “REALIST ORBCEL-C”- can improve outcomes in patients with ARDS. Patients are recruited in to the REALIST trial into one of two phases: phase I of the trial will recruit up to 18 patients receiving increasing doses of REALIST ORBCEL-C to confirm which dose is best tolerated in this patient group. Phase II of the trial will recruit a further 60 patients who will be randomly allocated to either a group which receives treatment with REALIST ORBCEL-C or a group that receives a dummy version (placebo) called Plasma-Lyte 148. Patients have a 1:1 chance of receiving MSCs or placebo. The REALIST trial will determine the safest tolerated dose of REALIST ORBCEL-C as well as analyse the effects of REALIST ORBCEL-C on patients with ARDS.
The aim of this study is to conduct a clinical trial of human umbilical cord derived mesenchymal stromal sells in patients with Acute Respiratory Distress Syndrome (ARDS).
Professor Danny McAuley