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Pediatrics/adolescents safe levels have been evaluated in adults, but not in children

Regulatory and GMP-focused analyses emphasize the need for rigorous definition of identity, purity, potency, safety, and stability criteria to generate clinical-grade EV products ( 7.5 Safety considerations and scalability of EV-based therapies EV-based therapies offer several theoretical safety advantages over whole-cell approaches, including the absence of proliferative capacity, lower immunogenicity, the ability to cross biological barriers, and reduced tumorigenic risk

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