Strain- and species-specific immune responses to human adipose stem cell-derived extracellular vesicles: A comparative pharmacological evaluation in mice and human PBMCs.

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Human adipose stem cell-derived extracellular vesicles (hASC-EVs) have gained attention as potential cell-free therapeutics in regenerative medicine due to their immunomodulatory properties and low immunogenicity. Despite this promise, their immunotoxicity profile remains insufficiently characterized, particularly across species and genetic backgrounds. This study systematically assessed immune responses to repeated high-dose intravenous administration of hASC-EVs in two murine strains-C57BL/6 (inbred) and ICR (outbred)-and in human peripheral blood mononuclear cells (hPBMCs) in vitro. Flow cytometry of murine blood and spleen samples revealed transient, strain-dependent shifts in immune cell populations, including neutrophils, monocytes, macrophages, B cells, and NK cells. Notably, C57BL/6 mice exhibited more pronounced fluctuations than ICR mice, reflecting the role of host genetics in EV-induced immunomodulation. In contrast, hPBMCs exposed to equivalent concentrations of hASC-EVs displayed no significant changes in cell viability, immune cell subset composition, or activation markers over a 24-hour period. While a mild, transient increase in CD86 + monocytes was observed at 6 h, this effect normalized by 12 h. These results suggest that hASC-EVs induce minimal and reversible immune responses in vivo and are immunologically inert in human immune cells under the tested condit

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

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