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

M. Kishta, A. M. Hafez, Tamer Hydara, Zeinab Hamed, M. Bahr, Ashraf A. Shamaa, Ahmed N. Abdallah

Stem cell research & therapeutics, 2025

110 participants · 44 citations

Abstract

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. 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…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 110 participants or records.

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