Key Takeaways & Executive Findings
- •• Human umbilical cord mesenchymal stem cell-derived exosomes significantly improve ulcer healing rate and shorten healing time in diabetic foot ulcers compared to vacuum-assisted closure therapy. • Exosome treatment markedly reduces serum inflammatory markers (IL-6, CRP, PCT) and increases growth factors (VEGF, bFGF, PDGF), indicating enhanced tissue repair. • The recurrence rate of diabetic foot ulcers is significantly lower with exosome therapy (13.9%) than with vacuum-assisted closure (27.8%) during follow-up. • Exosome therapy does not increase the risk of adverse events, supporting its safety and efficacy as a promising 'cell-free' therapeutic approach.
Abstract
BACKGROUND: Exosomes derived from mesenchymal stem cells play an important role in regulating apoptosis, promoting cell regeneration, and improving the wound microenvironment, making them a hot research topic in the treatment of diabetic foot ulcers. OBJECTIVE: To explore the clinical application value of exosomes derived from human umbilical cord mesenchymal stem cells in the repair of diabetic foot ulcers. METHODS: A retrospective analysis was conducted on the data from 72 patients with diabetic foot ulcers treated between May 2022 and April 2025. Thirty-six patients received treatment with exosomes derived from human umbilical cord mesenchymal stem cells (observation group), and 36 patients were managed with vacuum-assisted closure therapy (control group). Ulcer healing rate, incidence of adverse events, serum inflammatory markers, growth factor levels, total wound healing time, and ulcer recurrence rate during follow-up were compared between the two groups after 2 weeks of treatment. RESULTS AND CONCLUSION: (1) After 2 weeks of treatment, the ulcer healing rate in the observation group (48.03±6.12)% was significantly higher than that in the control group (30.13±6.38)%, with a significant difference (P < 0.05). (2) Ulcers healed in both groups, with healing time in the observation group (30.42±2.30) d significantly shorter than that in the control group (43.94±3.46) d (P < 0.05). (3) The incidence of adverse events during treatment was 13.89% in the control group and 19.44% in the observation group, with no significant difference (P > 0.05). (4) Serum levels of interleukin-6, C-reactive protein, and procalcitonin decreased significantly in both groups, with a greater decrease in the observation group (P < 0.01); serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and platelet-derived growth factor increased significantly in both groups, with a greater increase in the observation group (P < 0.01). (5) After ulcer healing, the observation group was followed for an average of 9.4 months, with 5 cases of ulcer recurrence; the control group was followed for an average of 9.8 months, with 10 cases of recurrence. The recurrence rate in the observation group was significantly lower than that in the control group (13.9% vs. 27.8%, P < 0.05). These results indicate that compared with vacuum-assisted closure therapy, application of exosomes derived from human umbilical cord mesenchymal stem cells for repairing diabetic foot ulcers can effectively inhibit inflammation, promote ulcer healing, and reduce recurrence rate without increasing the risk of related adverse events, demonstrating both efficacy and safety.
1. Introduction
Diabetic foot ulcer is one of the most serious complications of diabetes mellitus. Patients with diabetes have a 15% lifetime probability of developing diabetic foot ulcers, and approximately 36.55% of these patients eventually require amputation, with a 5-year mortality rate after amputation as high as 39%-68%. Therefore, diabetic foot ulcers have become a leading cause of disability and death in diabetic patients.
In recent years, stem cell therapy has attracted considerable attention for the treatment of diabetic foot ulcers. Stem cells possess high self-renewal capacity and multilineage differentiation potential, and can promote angiogenesis and wound healing. However, traditional stem cell therapy has limitations such as nonspecific differentiation, induction of tumors or excessive immune responses, and short half-life. Exosomes, as membranous vesicles secreted by stem cells, lack self-replication ability, have small structure, high stability, and can be stored long-term after cryopreservation or lyophilization. They can also be sterilized by filtration, facilitating clinical use. Compared with stem cell transplantation, exosome therapy can effectively reduce the risk of immune rejection and tumorigenesis, thus offering higher safety and easier storage and operation. Moreover, exosomes carry various bioactive molecules including RNA, proteins, and lipids, and can deliver genetic information and functional proteins to recipient cells via transmembrane transport, participating in various physiological and pathological processes. Studies have reported that mesenchymal stem cell-derived exosomes can significantly promote the regeneration of endothelial cells, fibroblasts, and keratinocytes in the wound microenvironment, and inhibit apoptosis, thereby accelerating wound healing. Currently, clinical observation of local application of mesenchymal stem cell-derived exosomes for diabetic foot ulcers is being conducted to provide reliable therapeutic evidence.
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LI Tianbo, YU Zeyang, QIN Xinyuan, WANG Jiangning, GAO Lei (2026). Exosomes derived from human umbilical cord mesenchymal stem cells in treatment of diabetic foot ulcers. Chinese Journal of Tissue Engineering Research. https://doi.org/10.12307/2026.21338
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Frequently Asked Questions
What is the role of human umbilical cord mesenchymal stem cell-derived exosomes in treating diabetic foot ulcers?
These exosomes improve wound healing by inhibiting inflammation, promoting angiogenesis and cell proliferation, and modulating the wound microenvironment. They also reduce ulcer recurrence rates without increasing adverse events.
How do exosomes compare with vacuum-assisted closure therapy for diabetic foot ulcers?
In this study, exosome therapy resulted in a significantly higher ulcer healing rate (48.03% vs. 30.13%) and shorter healing time (30.42 vs. 43.94 days) compared to vacuum-assisted closure, with lower recurrence rates (13.9% vs. 27.8%).
What are the safety outcomes of exosome therapy for diabetic foot ulcers?
The incidence of adverse events was not significantly different between exosome therapy (19.44%) and vacuum-assisted closure (13.89%), indicating that exosome therapy is safe and does not increase the risk of adverse events.
What biomarkers are affected by exosome therapy in diabetic foot ulcer patients?
Exosome therapy significantly reduces serum levels of inflammatory markers (interleukin-6, C-reactive protein, procalcitonin) and increases levels of growth factors (vascular endothelial growth factor, basic fibroblast growth factor, platelet-derived growth factor).
What is the clinical significance of this study?
This study provides clinical evidence that human umbilical cord mesenchymal stem cell-derived exosomes are an effective and safe 'cell-free' therapeutic approach for diabetic foot ulcers, offering a promising alternative to conventional treatments.
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