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Musculoskeletal and soft tissue healing depend on coordinated vascular support with resolution of inflammatory stress
Recent studies have revealed that Damage-Associated Molecular Patterns (DAMPs) (e.g., High Mobility Group Box 1 (HMGB1) via TLR4/Myeloid Differentiation Primary Response 88 (MyD88) signaling and mtDNA through the cyclic GMP-AMP synthase-stimulator of interferon genes (cGAS-STING) pathway) released by apoptotic bodies polarize Kupffer cells towards the M1 phenotype, promoting the secretion of inflammatory cytokines such as IL-1 and IL-18 , thus activating the NACHT , LRR and PYD domains-containing protein 3 (NLRP3) inflammasome and producing a second hit effect 51
The second submission was in response to a Complete Response Letter issued by the FDA in December 2019
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