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.
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.
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.
Parallel
Control
Biological/VaccineStandard treatment
Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
Biological/Vaccine3 doses of 5 million MSC will be administered
Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
Biological/Vaccine6 doses of 5 million MSC will be administered
Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia
Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.
feasibility variable
Number of days of life from birth to administration of the first dose and number of days of life in successive doses.
Incidence of BPD and PH in very low birth weight babies treated with MSC
Status on week 36 of post-menstrual age
Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen
(No BPD/grade 1/grade 2/garde 3)
Exitus on week 36 and 40 of post-menstrual age or at hospital discharge
(Yes/No)
Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death.
(sepsis confirmed by blood culture, treated patent ductus arteriosus, non-pharmacological ductal closure, necrotising enterocolitis, isolated bowel perforation, intraventricular haemorrhage ≥ 2, retinopathy ≥ grade 2)
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