ControlAllogenic fetal mesenchymal stem cells from umbilical cord - three infusionsAllogenic fetal mesenchymal stem cells from umbilical cord - six infusions
Control: Standard treatment
Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions: 3 doses of 5 million MSC will be administered
Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions: 6 doses of 5 million MSC will be administered
Study 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
Sex
ALL
Min age
1 Month
Max age
28 Weeks
Healthy volunteers
No
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
Primary outcome measure(s)
Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia — 24 months Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.
feasibility variable — 24 months Number of days of life from birth to administration of the first dose and number of days of life in successive doses.
Trial sites (7)
Facility
City
Region
Status
Hospital Quironsalud Madrid
Pozuelo de Alarcón
Madrid
Recruiting
Complejo Hospitalario La Coruña
A Coruña
Spain
Recruiting
Hospital Clínico San Carlos
Madrid
Spain
Recruiting
Hospital Universitario La Paz
Madrid
Spain
Recruiting
Hospital Universitario Carlos Haya
Málaga
Spain
Recruiting
Hospital Vírgen del Rocío
Seville
Spain
Recruiting
Hospital Universitario y Politécnico La Fe
Valencia
Spain
Recruiting
More Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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