The safety of a therapeutic product composed of a combination of stem cell released molecules from adipose mesenchymal stem cells and fibroblasts.

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)

Aim We sought to determine the safety profile of a therapeutic candidate composed of the released molecules from a combination of human adipose-derived mesenchymal stem cells and fibroblasts. Although stem cells, their progenitor cells and the molecules that are released from these cells have some demonstrated therapeutic value, much more needs to learn about the efficacy, mechanism of action and the safety profiles of these stem cell-based therapeutics. Methods A number of cellular, in vitro , in vivo and human studies were performed to analyze cellular, tissue and systemic safety profiles of the combinatorial product. Results At the levels tested in this study, ranging from demonstrated therapeutic doses to supratherapeutic doses, the combinatorial product demonstrated an excellent safety profile in all in vitro , cellular, tissue and systemic studies. Conclusions We found evidence that a therapeutic candidate composed of the molecules released from human adipose-derived mesenchymal stem cells and human fibroblasts has an excellent safety profile, and that the product warrants further studies for safety and efficacy where dosing may include topical application, injection and oral application.

Evidence level

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

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