Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Trial Parameters
Brief Summary
Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients.
Eligibility Criteria
Inclusion Criteria: * Alive newborns weighing ≤ 1250 grams and GA ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥0.3 between days 5 and 14 of life, with no immediate extubation foreseeable. Exclusion Criteria: * Presence of another concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary haemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies. * Presence of refractory haemodynamic instability of any cause at the time of inclusion. * Presence of severe neurological damage at the time of inclusion (HIV grade III or higher). * Patients who have required major surgery in the 72 hours prior to inclusion. * Patients who have necrotising enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification. * Patients who are children of a mother with HIV