ABSTRACT
The acute respiratory distress syndrome (ARDS) is a life-threatening medical condition in which the lung is injured or inflamed to the degree that it cannot properly exchange gases and oxygenate the body. ARDS can be caused by a variety of conditions including trauma, severe blood loss, multiple or large volume blood transfusions, burns, and infections. The development of therapeutics that can limit the severity and/or progression of lung injuries that lead to ARDS and death is an immediate clinical need in both military and civilian sectors. Experimental studies carried out in small and large animals have demonstrated that specialized cells called mesenchymal stromal cells (MSC) can effectively reduce inflammation in multiple diseases including ARDS. The overall objective of this proposal is to carry out a randomized, blinded, placebo-controlled, multicenter phase 2b trial to test the therapeutic potential of allogeneic bone-marrow derived MSC for treating ARDS, with a major focus on civilian trauma patients. The specific aims of this project are: Specific Aim 1. To test the clinical efficacy of intravenously delivered allogeneic human MSC in patients with ARDS. Specific Aim 2. To test the mechanisms by which MSC reduce acute lung injury in patients with ARDS.