Start/end date: 30 august 2024 – september 2026
Funding Agency/Programme: Italian Ministry of Health – National Recovery and Resilience Plan (NRRP) – Mission 6 – Component 2 – Investment 2.1. Strengthening and enhancing biomedical research in the NHS_CALL 2023
Partnership: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione – ISMETT (Applicant – UO1); Fondazione Ri.MED (partner – UO2).
Abstract: Esophageal stenosis is characterized by a reduction in the lumen diameter caused by cancer, chronic inflammation, or ulcerative processes. Despite the use of pharmacological treatments aimed at reducing tumor growth and mediating the inflammatory process, approximately 35% of patients who have undergone surgery to address esophageal stenosis experience a recurrence of the condition. The gold-standard remedy for benign esophageal stenosis is endoscopic dilation, a procedure generally considered effective and easy to perform. Current procedures to reduce the risk of recurrence include the endoscopic placement of various types of stents, including both covered and uncovered self-expanding metal stents (SEMS) and self-expanding plastic stents (SEPS). Although SEMS and SEPS allow for effective dilation of the stenotic area, their main disadvantage remains the migration rate (approximately 35%). To overcome the limitations of esophageal grafts, a biohybrid medical device will be developed using advanced tissue engineering technologies, as described by D’Amore et al., 2016. This graft will be compared to a Niti-S stent (Taewoong Medical Co., Ltd, Goyang-si, Korea) as it features characteristics such as silicone coating and flared ends with rounded edges designed to potentially reduce obstruction from tissue infiltration between the mesh and hyperplastic mucosal reaction at the ends. In collaboration with the UO1-ISMETT Endoscopy unit, the D’Amore group proposes to design, characterize, and validate a biohybrid esophageal graft without a stent in a clinically relevant animal model. This graft is expected to provide sustained mechanical support, release active pharmaceutical ingredients, and deliver bioactive components derived from the extracellular matrix (ECM) to induce constructive tissue remodeling. Specifically, the biohybrid graft in question is capable of providing mechanical resistance to buckling and device migration.
Ri.MED UO: Ingegneria del Tessuto Cardiovascolare
Ri.MED Principal Investigator: Antonio D’Amore
Other Ri.MED collaborators: Laura Modica de Mohac, Federica Cosentino