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The release of pro-inflammatory cytokines such as IL-1, IL-6, TNF-α, and IL-17 leads to increased immune-cell activation and recruitment, creating an environment conducive to viral replication [2]
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The FDA’s position on allogeneic exosomes is stronger than merely unapproved: the agency has stated that marketing and administering them without an approved biologics licence or an active investigational application falls outside what federal law permits, and it has issued public safety communications after reported patient harm
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