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Cell therapy protocol 2 is a combination therapeutic regimen developed by the Royan Institute for the treatment of Acute Respiratory Distress Syndrome (ARDS), specifically in patients with COVID-19. The protocol involves the sequential administration of allogeneic Mesenchymal Stem Cells (MSCs) and MSC-derived Extracellular Vesicles (EVs). MSCs are known for their potent immunomodulatory properties, secreting anti-inflammatory factors and interacting with host immune cells to mitigate the hyper-inflammatory response or 'cytokine storm' characteristic of severe ARDS. The subsequent administration of EVs—nano-sized membrane vesicles containing bioactive proteins, mRNA, and microRNA—aims to enhance lung tissue repair and stabilize the alveolar-capillary barrier. This dual approach is designed to provide both immediate cellular immunomodulation and sustained regenerative signaling to improve respiratory function and survival in critically ill patients.
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