Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of special cells called mesenchymal stem cells, taken from umbilical cords, to help treat preterm newborns with a condition known as bronchopulmonary dysplasia (BPD). BPD is a serious lung problem that can occur in babies born too early, affecting their ability to breathe properly. The trial aims to see if these stem cells can help improve lung development and reduce the chances of developing BPD in these vulnerable infants.

To be eligible for this trial, babies must be born weighing 1250 grams or less and at 28 weeks of pregnancy or earlier. They should also be receiving breathing support through a ventilator. However, babies with certain other health issues, like severe lung or heart problems, recent major surgeries, or specific infections, cannot participate. If families choose to enroll their child, they can expect close monitoring and care throughout the study, as researchers aim to understand how these stem cells might help improve lung health in preterm infants.

Gender

ALL

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