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The letters cited violations of the Federal Food, Drug, and Cosmetic Act and made explicit that "research use only" labels do not exempt products marketed for human use from federal requirements [5][14][15]

Thus, MSC-derived EVs represent an innovative cell-free therapy with compelling advantages over parent MSCs, holding significant potential for driving tissue repair and regeneration 26

Neurological: Headache, dizziness, fatigue, and somnolence (sleepiness/drowsiness), or temporary tiredness/yawning following injection

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Malkin SJP, Hunt B, Huisman EL, Grand TS, Chubb B