Assessment of the safety of mesenchymal stem cells of the olfactory epithelium using for the chronic polypous rhinosinusitis treatment

Background. The most common method for treating chronic polypous rhinosinusitis is functional endoscopic sinus surgery followed by the use of intranasal corticosteroids in the postoperative period. Considering the recurrent nature of the disease, with only about 50% effectiveness of medical therapy, and the increased risk of complications with multiple surgical interventions, there is a need to explore new treatment methods for chronic polypous rhinosinusitis. An important aspect is restoring the epithelial barrier of the nasal mucosa and reducing inflammatory processes within it to alleviate symptoms. Mesenchymal stem cells, which possess a wide range of immunomodulatory properties, may become a promising new therapeutic option for this condition.

Results. The tolerability of immunotherapy with a biomedical cell product based on mesenchymal stem cells from the olfactory epithelium was good in all patients (n = 27). However, local reactions, such as nasal mucosa edema at the injection site and color change of the nasal mucosa to bluish-pink, without clinical manifestations at the site of suspension administration were observed in 5 patients (36%) in Group 1 and in 2 patients (15%) in Group 2. No systemic reactions (such as fever, changes in heart rate, blood pressure, or immediate allergic responses) were detected. In all patients of both the main and control groups, general, biochemical, and immunological blood parameters remained within normal ranges at all stages; no statistically significant differences or clinically relevant deviations were found. These data suggest that additional cell therapy alongside standard treatment for chronic polypous rhinosinusitis does not exert systemic effects on the body based on complete blood count data (p > 0.05).

Conclusion. Cell therapy with a biomedical cell product based on mesenchymal stem cells from the olfactory epithelium is safe and well tolerated in patients with chronic polypous rhinosinusitis. The local application of mesenchymal stem cells from the olfactory epithelium does not produce systemic effects according to blood tests, biochemical analysis, or immunological studies. Local reactions at the injection site-such as mucosal color change or edema – may occur but without clinical significance.

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