The transforming role of wharton's jelly mesenchymal stem cell-derived exosomes for diabetic foot ulcer healing: a randomized controlled clinical trial

Abstract

Background: Diabetic foot ulcers (DFUs), which have high rates of recurrence, amputation, and death, are a significant complication in the therapy of diabetes. Chronic inflammation, vascular dysfunction, and peripheral neuropathy are the results of their etiology, which includes dysregulated glucose homeostasis. These elements contribute to the poor clinical outcomes of DFUs and their complexity. Exosomes, which are natural nanovesicles that promote intercellular communication by transporting functional molecular cargos such as proteins, lipids, and nucleic acids, are being investigated as novel treatment approaches for diabetic foot ulcers (DFUs). These exosomes present a viable therapy option for DFU because they can alter cellular functions and promote wound healing.

Methods: To improve wound healing in patients with diabetic foot ulcers (DFUs), we assessed the safety and effectiveness of Wharton's jelly-derived mesenchymal stem cell (WJ-MSC) exosomes in this study. 110 individuals with persistent DFUs participated in our research. Three groups were randomly selected from among the participants. For 4 weeks, the first group got weekly topical application of WJ-MSC exosome along with standard of care (SOC); the second control group received SOC alone; and the third placebo group received SOC together with CMC (the exosome vehicle). While effectiveness outcomes comprised the rate of wound closure and the duration to full epithelialization, safety endpoints included the frequency of adverse events.

Results: According to our study's findings, 53 patients (62%) had fully recovered by the end of the study, and the treated group had a significantly higher percentage of patients who had fully recovered than the control group. The treated group's mean time to fully recover was 6 weeks (range: 4-8 weeks), while the controls were 20 weeks (range: 12-28 weeks).

Conclusions: Our research proved that MSC-Exos is a viable treatment option for DFUs. MSC-Exos provide a multimodal approach to improve wound healing outcomes in diabetes patients.