1. Protective and regenerative effects of a novel medical device against esophageal mucosal damage using in vitro and ex vivo models
- Author
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Emiliana Giacomello, Roberta Bulla, Fleur Bossi, Daniele Greco, Andrea Balduit, Francesco De Seta, Dario Voinovich, Giuseppe Ricci, Vito Rodolico, Beatrice Belmonte, Micol Pacor, Chiara Agostinis, Alessandro Mangogna, Agostinis, C., Bossi, F., Mangogna, A., Balduit, A., Pacor, M., Giacomello, E., Belmonte, B., Greco, D., Rodolico, V., Voinovich, D., De Seta, F., Ricci, G., Bulla, R., Agostinis C., Bossi F., Mangogna A., Balduit A., Pacor M., Giacomello E., Belmonte B., Greco D., Rodolico V., Voinovich D., De Seta F., Ricci G., and Bulla R.
- Subjects
0301 basic medicine ,Esophageal Mucosa ,Hyaluronic acid ,RM1-950 ,Pharmacology ,Permeability ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Pepsin ,Cell Line, Tumor ,Digestive disorder ,Medicine ,Humans ,Regeneration ,Esophagus ,Amino Acids ,Hyaluronic Acid ,Evans Blue ,Medical device ,biology ,business.industry ,Bioadhesive polymer ,Gastroesophageal reflux disease (GERD) ,Rice extract ,Plant Extracts ,Adhesiveness ,Oryza ,General Medicine ,medicine.disease ,digestive system diseases ,030104 developmental biology ,medicine.anatomical_structure ,chemistry ,Equipment and Supplies ,030220 oncology & carcinogenesis ,biology.protein ,GERD ,Gastroesophageal Reflux ,Therapeutics. Pharmacology ,business ,Wound healing ,Ex vivo - Abstract
Gastroesophageal reflux disease (GERD) is a common digestive disorder that causes esophagitis and injuries to the esophageal mucosa. GERD symptoms are recurrent during pregnancy and their treatment is focused on lifestyle changes and nonprescription medicines. The aim of this study was to characterize the mechanism of action of a new patented medical device, an oral formulation containing hyaluronic acid, rice extract, and amino acids dispersed in a bioadhesive polymer matrix, by assessing its protective effects in in vitro and ex vivo models of esophageal mucosa damage. Acidic bile salts and pepsin cocktail (BSC) added to CP-A and COLO-680 N esophagus cells were used as an in vitro GERD model to evaluate the binding capacities, anti-inflammatory effects and reparative properties of the investigational product (IP) in comparison to a viscous control. Our results showed that the IP prevents cell permeability and tight junction dysfunction induced by BSC. Furthermore, the IP was also able to down-regulate IL-6 and IL-8 mRNA expression induced by BSC stimulation and to promote tissue repair and wound healing. The results were confirmed by ex vivo experiments in excised rat esophagi through the quantification of Evans Blue permeability assay. These experiments provided evidence that the IP is able to bind to the human esophagus cells, preventing the damage caused by gastroesophageal reflux, showing potential anti-irritative, soothing, and reparative properties.
- Published
- 2020