Efficacy and safety of mesenchymal stem cell therapy in radiation induced xerostomia in patients with head and neck carcinoma: A systematic review and meta analysis of randomized controlled trials.

Abstract

e18015 Background: Radiation-induced xerostomia, a common complication of head and neck radiotherapy, severely impacts quality of life by reducing salivary flow and causing oral discomfort. Adipose-derived mesenchymal stem cell (ASC) therapy offers a potential regenerative solution for irradiated salivary glands. This study evaluates efficacy and safety of mesenchymal stem cell therapy for radiation-induced xerostomia in head and neck cancer patients. Methods: We performed an electronic search on PubMed, Embase, and Cochrane, from the inception of databases until December 2024, to identify all articles evaluating adipose- or mesenchymal-derived stem cell therapy in patients with radiation-induced xerostomia. The data were extracted and pooled using a random effects model to calculate the mean difference (MD) with respective 95% confidence intervals (CI) for continuous outcomes, and the risk ratio (RR) with 95% CI for dichotomous outcomes. The I 2 and χ2 were used to assess interstudy heterogeneity. “Metafor” package in R Studio (v.4.4.2) was used for statistical analyses. A p value of <0.05 was considered statistically significant. Results: This meta-analysis included two randomized controlled trials involving 150 patients (75 treatment; 75 control) undergoing radiotherapy with mean follow-up time 14 months. We found no statistically significant difference in all-cause mortality (RR 0.15, 95% CI 0.02-1.18, I 2 =0%, P=0.49), unstimulated salivary flow rate (mL/min) (MD 0.04, 95% CI 0.01-0.071], I 2 =0%, P=0.5207), stimulated salivary flow rate (mL/min) (MD -0.05 95% CI -0.16 to 0.07, I 2 =0%, P=0.89), and serious adverse events (RR 1.13 95% CI 0.02-67.66, I 2 =85.2% P=0.0094) in two groups. Conclusions: Mesenchymal stem cell therapy showed no statistically significant improvement in salivary flow rates or serious adverse events in patients with radiation-induced xerostomia. Large-scale, multi-center trials are needed to establish conclusive evidence.