Freeze-Dried, Not Frozen: Lyophilized Mesenchymal Stromal Cell-Derived Extracellular Vesicles and Therapeutic Function in Neuroinflammatory Models.

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)

Background Mesenchymal stromal cell (MSC)-derived extracellular vesicles (EVs) offer a promising acellular therapy for immune modulation, but clinical translation is hindered by variability and storage constraints. Lyophilization (freeze-drying) could enable shelf-stable EV therapeutics, although its effects on biological activity remain incompletely defined. Study design We compared the immunomodulatory effects of frozen and lyophilized EVs from bone marrow (BM), adipose tissue (AD), and umbilical cord (UC) MSCs using lipopolysaccharide-stimulated rodent splenocytes and microglial models and human peripheral blood mononuclear cells (PBMCs). Variables included batch scale (small vs large), cytokine priming, and MSC source. Tumor necrosis factor alpha (TNF-α) secretion was measured as a marker of inflammation. Results Lyophilized small-batch BM-derived MSC EVs consistently suppressed TNF-α in rodent splenocytes and microglia. Large-batch and cytokine-stimulated EVs showed more variable responses. UC- and AD-derived EVs elicited inconsistent effects in rodent splenocytes. In contrast, lyophilized UC- and AD-derived EVs on human PBMCs exhibited reproducible suppression of TNF-α across 3 donors. Conclusions Lyophilized MSC-EVs-particularly from UC MSCs-retain immunomodulatory function and perform comparably or better than frozen counterparts. Although rodent models revealed signifi

Evidence level

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

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