Abstract
INTRODUCTION.
Implementation of the state strategy “Pharma 2030” requires the development of high-tech domestic drugs, including acellular tissue-engineered composites characterized by high efficacy and low immunogenicity. As part of this effort, a regenerative spray for the treatment of grade IIb–IIIa burn wounds is being developed and its pharmacological properties are being studied. This spray is a tissue-engineered composite of acellular human umbilical cord biomaterial and an antimicrobial component.
AIM.
To evaluate the regenerative activity of experimental spray formulations derived from human umbilical cord Wharton’s jelly in a rat burn model.
MATERIALS AND METHODS.
The developed spray formulations contained a biodegradable lyophilized hydrolysate of the acellular matrix of human umbilical cord Wharton’s jelly and antibacterial agents: formulation No. 1 included gentamicin sulfate, formulation No. 2 included neomycin sulfate. Olazol aerosol (Altayvitamins, Russia) was used as the reference drug. The study was performed on a deep burn model in adult rats. The animals were divided into groups that received treatment with the experimental sprays, the reference drug, a control group (no treatment), and a group of intact animals. Regenerative activity was assessed by measuring the wound defect area and by determining blood leukocyte count, C-reactive protein (CRP) concentration, and epidermal growth factor (EGF) level.
RESULTS.
By day 28 of observation, both spray formulations showed a statistically significant advantage over the reference drug in reducing the burn wound area: formulation No. 1 by 66%, formulation No. 2 by 20%. Treatment with the experimental formulations and the reference drug resulted in a decrease in leukocyte count and CRP level to values comparable with those of intact animals. The blood EGF concentration increased significantly in the experimental groups: with formulation No. 1 by 104.0% and with formulation No. 2 by 76.5% compared with the control group, and by 106.5% and 78.8%, respectively, compared with the intact animal group.
CONCLUSIONS.
The experimental spray formulations derived from human umbilical cord Wharton’s jelly demonstrate high regenerative activity, significantly accelerating the healing of deep burn wounds and reducing the severity of the inflammatory response in rats. The results support the feasibility of further preclinical and clinical investigation of these compositions, with a view to their introduction into clinical combustiology.