Evidence map›Paper›PMID 41084065›Full record

Trial reportStem cell research & therapy2025

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

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

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Mohamed S KishtaHormones Department, Medical Research and Clinical Studies Institute, National Research Centre, Dokki, 12622, Cairo, Egypt. kishtamsa@gmail.com.ORCID http://orcid.org/0000-0002-2314-8820
A M HafezMedical Biochemistry Department Faculty of medicine, Kafr Elsheikh University, Kafr El-Sheikh, Egypt.
Tamer HydaraDepartment of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh, 33516, Egypt.
Zeinab HamedSurgery, Anesthesiology and Radiology department, Faculty of Veterinary, Medicine Cairo University, Cairo, Egypt.
Mohamed M BahrSurgery, Anesthesiology and Radiology dept, Faculty of Veterinary Medicine, Cairo University, Cairo, Egypt.
Ashraf A ShamaaSurgery, Anesthesiology and Radiology dept, Faculty of Veterinary Medicine, Cairo University, Cairo, Egypt.
Ahmed N AbdallahHormones Department, Medical Research and Clinical Studies Institute, National Research Centre, Dokki, 12622, Cairo, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiabetic 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.

methodsTo 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.

resultsAccording 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).

conclusionsOur 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.

Indexed as

Diabetic FootExosomesMesenchymal Stem CellsMesenchymal Stem Cell TransplantationWharton JellyWound HealingAdultAgedFemaleHumansMaleMiddle Aged

Identifiers

PMID41084065
PMCPMC12519741

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.