In Italy, over 30,000 premature babies are born every year (7% of all births), i.e. children who come into the world before the 37th week of gestational age. Among these premature newborns, those weighing less than 1500 grams develop, in 45% of cases, a chronic lung disease called bronchopulmonary dysplasia which requires prolonged oxygen therapy for weeks or months with consequences that can persist into adulthood. There are currently no effective and safe treatments available for this disease.
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A drug from umbilical cord cells
In July 2023, the European Medicines Agency (EMA) approved the first clinical trial based on the therapeutic use of extracellular vesicles, a natural product isolated from umbilical cord cells for the prevention of bronchopulmonary dysplasia, the chronic lung disease of infants born prematurely. The trial was then approved by the National Ethics Committee and by AIFA (Italian Medicines Agency).
The study on newborns weighing less than 1500 grams
The international clinical trial starts at the Neonatal Intensive Care Unit of the University Hospital of Padua, the Triveneto hub center for prematurity, and newborns weighing less than 1500 grams will be included in the study. The trial is coordinated by the Padua center and involves 4 Italian neonatal hospitals (Florence, Genoa, Milan and Modena) and 2 in Belgium.
A new therapy
“This is a Phase 1 study which involves the use of a new therapy, extracellular vesicles, in premature newborns, which in the preclinical phases (in vitro and in vivo) have presented extremely promising results and excellent safety – he explains the professor. Eugenio Baraldi, director of the Department of Women’s and Children’s Health of Padua and scientific director of the IRP Città della Speranza -. These microvesicles, thanks to their content of numerous mediators, present anti-inflammatory and pro-regenerative activity of immature lungs, representing an extremely innovative approach for the prevention and treatment of bronchopulmonary dysplasia.”
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This translational research “made in Padua” is the result of a project born from the synergy between the University of Padua, the Hospital and the Città della Speranza Pediatric Research Institute. The clinical trial will be coordinated by the Neonatal Intensive Care Unit of the University Hospital of Padua which will analyze data from Italian and foreign neonatal departments. Translational research aims to transform the results obtained from basic research carried out at the Pediatric Research Tower into clinical applications at the patient’s bedside.
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The Italian primacy
It is the first study in Europe to receive the green light from the EMA, the body responsible for monitoring the safety and effectiveness of medicines, but it is also the first in the world to use this natural product, satisfying all the requirements of the regulatory bodies. This was possible thanks to the collaboration with a Belgian pharmaceutical group, which developed a product compatible with pharmaceutical standards based on the patents registered at the University of Padua and the Pediatric Research Institute.
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