The transforming role of wharton's jelly mesenchymal stem cell-derived exosomes for diabetic foot ulcer healing: a randomized controlled clinical trial
Kishta MS., Hafez AM., Hydara T., Hamed Z., Bahr MM., Shamaa AA.
Clinical Trial with a reported sample of 53 on Diabetic Foot, Chronic Wound, Chronic Inflammation, published in Stem Cell Res Ther (2025) — summary generated from the PubMed abstract.
Several human studies show positive signals, while research methods and sample sizes continue to develop.
- 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
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- Study type
- Clinical Trial
- Journal
- Stem Cell Res Ther (2025)
- Reported sample size
- 53
- Source database
- Europe PMC
- PMID
- 41084065
- PMCID
- PMC12519741
- DOI
- 10.1186/s13287-025-04690-y
- Citations
- 5
Abstract (original English)
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 rat
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Several human studies show positive signals, while research methods and sample sizes continue to develop.
How we grade evidenceBrowse all related research
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