Clinical Trials Logo

Remestemcel-L clinical trials

View clinical trials related to Remestemcel-L.

Filter by:
  • Terminated  
  • Page 1

NCT ID: NCT04371393 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

MSCs in COVID-19 ARDS

Start date: April 30, 2020
Phase: Phase 3
Study type: Interventional

The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.