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Royan Institute MSC-EV therapy is an investigational cell-based biologic treatment developed by the Royan Institute for Stem Cell Biology and Technology in Iran. It is specifically designed for the treatment of acute respiratory distress syndrome (ARDS), particularly in patients with severe COVID-19. The therapy consists of allogeneic mesenchymal stromal cells (MSCs) derived from perinatal tissues, such as the umbilical cord and placenta, and MSC-derived extracellular vesicles (EVs). The treatment functions through immunomodulatory mechanisms, aiming to reduce systemic inflammatory markers and mitigate the cytokine storm associated with severe respiratory failure. Clinical protocols involve the intravenous administration of MSCs and the respiratory inhalation of EVs to target lung inflammation directly. The therapy has been evaluated in Phase 2/3 clinical trials to assess its safety and efficacy in reducing pro-inflammatory cytokines.
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