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DB-002 is a second-generation (Gen-2) mesenchymal stem cell (MSC)-derived extracellular vesicle (EV) therapeutic developed by Direct Biologics. Building on the technology of their first-generation product, ExoFlo (DB-001), DB-002 is a bone marrow-derived MSC-EV product characterized by enhanced purity, potency, and manufacturing scalability. It functions as a multi-target regenerative medicine, delivering a complex payload of proteins, microRNAs, and lipids directly to damaged tissues. The primary mechanism of action involves the systemic modulation of the immune system, particularly the suppression of the cytokine storm associated with severe inflammatory conditions. DB-002 promotes the transition of macrophages from a pro-inflammatory M1 state to a pro-resolving M2 state and reduces the levels of key inflammatory markers such as IL-6, TNF-α, and IL-1β. It is currently being investigated in clinical trials for its potential to treat severe inflammatory and respiratory diseases, including Acute Respiratory Distress Syndrome (ARDS).
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