Efficacy of exosomes in a chronic skin lesion model in vivo

Introduction. Chronic skin ulcers, including radiation-induced ones, are associated with impaired regeneration, chronic inflammation and a high risk of complications, which requires new approaches to treatment due to the low efficiency of traditional methods. Modern methods of regenerative medicine, such as application of biopolymer coatings and exosomal drugs, promote tissue restoration by improving the microenvironment, stimulating cellular activity and modulating inflammation. Aim. To develop a model of chronic radiation-induced skin injury and assess the therapeutic efficacy of monotherapy with medical device SPHERO®gel, exosome therapy (manufactured by New Medicine Stem Cell Clinic), and their combination in laboratory animals. Materials and methods. The study involved 48 male Wistar rats subjected to fractionated X-ray irradiation (5 × 10 Gy), mechanical skin injury, and persistent inflammation induced by lipopolysaccharide (LPS) injection. Animals were randomized into four groups: control, SPHERO®gel, exosomes (manufactured by New Medicine Stem Cell Clinic), and combined treatment. Therapy was applied for 28 days. Wound healing efficacy was evaluated using ulcer area morphometry (ImageJ) and histological examination. Results and discussion. Both SPHERO®gel and exosome (New Medicine Stem Cell Clinic) therapy significantly enhanced tissue repair, reduced fibrosis and inflammation. The combined therapy resulted in complete epithelialization in 75 % of animals, normalized angiogenesis, and restored dermal architecture. Conclusion. The combination of SPHERO®gel and exosomes (manufactured by New Medicine Stem Cell Clinic) demonstrates a synergistic effect in the treatment of chronic radiation-induced ulcers and holds promise for clinical application in regenerative and restorative medicine. © 2025 Elsevier B.V., All rights reserved.