Safety evaluation of extracellular vesicles derived from hypoxia primed mesenchymal stem cells of umbilical cord and adipose tissue.

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)

Extracellular vesicles (EVs) hold great promise as regenerative therapeutics due to their roles in intercellular communication and tissue repair. This study aimed to assess the safety of EVs derived from human mesenchymal stem cells (MSCs) obtained from both umbilical cord (UC-MSC-EVs) and adipose tissue (AD-MSC-EVs) sources, which were manufactured under xeno- and serum-free conditions and primed with 5% O2. EVs from neither source caused vascular or muscular stimulation in New Zealand rabbits. Systemic hypersensitivity tests revealed that neither UC-MSC-EVs nor AD-MSC-EVs triggered significant changes in allergic and immune responses or hematological parameters in the animals, highlighting their biocompatibility and safety when administered systemically. Furthermore, acute toxicity test using Swiss mice showed all mice survived without any signs of acute toxicity after intravenous injection of both types of EVs at very high doses (up to 10,000 µg/kg of body weight). In addition, subchronic toxicity examination in Wistar rats revealed that repeated injections of neither UC-MSC-EVs nor AD-MSC-EVs (50–150 µg/animal) affected hematological indices or the functions of the liver, kidney, or spleen. Collectively, our findings provide strong evidence that both UC-MSC-EVs and AD-MSC-EVs manufactured under xeno- and serum-free conditions and primed with 5% O2 are safe for potential the

Evidence level

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

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