Assessment of the Effect of Storage Conditions on the Quality of a Biomedical Cell Product Derived from Human Dermal Fibroblasts

Background: The efficacy of cell therapy directly depends on the viability and functional activity of cells in the ready-to-use cell product. The search for optimal storage conditions for a cellular product remains an urgent challenge as there is currently no universally accepted method for ensuring the stability of the final product during storage and transportation, thereby requiring the determination of optimal temperature conditions and storage duration. Objective: To determine the optimal storage conditions for a final biomedical cell product based on a suspension of human dermal fibroblasts to ensure their morphofunctional stability. Materials and methods: The study used a ready-to-use cell product based on cultured human dermal fibroblasts, passage 5. After reaching confluence, the cells were detached from the culture flasks by trypsinization. The resulting cell pellet was resuspended in saline solution and incubated at temperatures of +4 °C, +22 °C and +37 °C for 12, 24 and 36 hours. At the end of the storage period, the number and viability of cells, metabolic activity, endotoxin presence, as well as adhesive and proliferative properties during subsequent culture were evaluated. Results: The study showed that at a temperature of +22 °C, compared with other temperature conditions, fibroblasts demonstrated the highest viability and functional activity. At this temperature, the cells retained their ability to adhere, proliferate, and maintain secretory activity for 12 hours of storage. With an increase in storage duration to 24 and 36 hours, a statistically significant decrease in the cell number, their metabolic and secretory activity, was observed in all experimental groups. Conclusion: Storage of human dermal fibroblasts in suspension at +22 °C for 12 hours ensures the preservation of cell viability, metabolic activity, and morphofunctional properties, making this condition optimal for storage and transportation of fibroblasts as part of ready-to-use cell products.