Secretome of Human MSC Gel Improves DFU Healing through NF-κB p50 and CD163 mRNA Expression

Sadyah N.A.C., Putra A., Heri-Nugroho, Riwanto I.

Abstract

Background and Objective: Diabetic foot ulcers (DFUs) remain a critical clinical problem and stem cell-derived secretome reared under hypoxic conditions has been shown to play a significant role in tissue repair via immunomodulation. This study aimed to evaluate the secretome of human mesenchymal stem cell gel (SH-MSC gel) in DFU patients with grades 2 and 3 through reduced wound volume and modulation of CD163 and NF-κB p50 mRNA expression. Materials and Methods: A prospective, randomized controlled clinical trial involved 16 DFU patients with grades 2 and 3. Participants received either a placebo gel or an intervention gel containing secretome from Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) cultured under hypoxic conditions. All patients received standard wound care. Primary outcomes included changes in wound volume and expression levels of CD163 and NF-κB p50 mRNA in wound tissue, assessed using quantitative PCR. The Shapiro-Wilk test assessed normality and for normally distributed data, paired t-tests (within-group) and unpaired t-tests (between-group) were used. One-way ANOVA compared means across groups, while the Kruskal-Wallis test followed by post hoc analysis was employed for non-parametric data (p<0.05). Statistical analysis was performed using GraphPad Prism 10. Results: Baseline characteristics of participants did not show significant differences between the groups. Treatment with SH-MSC gel significantly enhanced wound healing compared to the placebo group, evidenced by a marked reduction in wound volume after 7 days (95% CI (0.467 to 1.18), p<0.001). The CD163 mRNA expression significantly increased in the SH-MSC gel group post-treatment (95% CI (-2.20 to-1.11), p<0.001), while NF-κB p50 mRNA expression significantly decreased (95% CI (0.349 to 0.688), p<0.001). Conclusion: The clinical trial results suggested that SH-MSC gel effectively improves wound healing in DFUs. Further research is warranted to explore additional inflammatory markers to better understand DFU treatment.

Journal
Pakistan Journal of Biological Sciences
Page Range
151-161
Publication date
2025
Total citations
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