The safety and efficacy of platelet-derived exosomes for grade II diabetic foot ulcers in a phase I clinical trial

Objective(s): Exosomes are extracellular vesicles derived from various cell types. Platelet-derived exosomes contain growth factors and cytokines that contribute to tissue repair. This study assessed the safety and efficacy of platelet-derived exosomes in treating diabetic foot ulcers.Materials and Methods: Platelet-derived exosomes were isolated by ultracentrifugation and subsequently characterized. Fourteen patients with diabetes and grade II diabetic foot ulcers were included in the study based on the inclusion and exclusion criteria. Exosome injections at a concentration of ۵۰ µg/ml and a volume of ۱.۵ ml were administered at one-week intervals. Safety and efficacy were assessed through clinical evaluation, measurements of wound dimensions, and laboratory analyses.Results: No significant adverse clinical events or changes in laboratory test results were observed after exosome injection in the patients. None of the patients' wounds in the control group healed completely within one month. However, a decrease in wound size was observed in ۳ patients in the control group. In the intervention group, the wounds of two patients completely closed within one month after PLT-Exo injection, and the wound dimensions of ۴۲.۸۵% of the patients exhibited a decreasing trend.Conclusion: Diabetic foot ulcers remain a significant wound-healing challenge among affected patients. Because limb amputation has serious consequences, these ulcers require considerable attention, and current treatment modalities often fail. The present study highlighted the safety, efficacy, and clinical feasibility of platelet-derived exosomes. For wider clinical application, further studies under varied conditions and with larger patient groups are recommended.

کلیدواژه ها:

Diabetic foot ulcers ، Exosome ، Extracellular vesicles ، Wound healing