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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-28
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Control
  • Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
  • Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions

Treatment groups

75 Participants
are divided into 3 treatment groups