Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Recruiting now · Phase 2
Conditions studied: Bronchopulmonary Dysplasia
In brief
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.
Key facts
- Study ID
- NCT06270199
- Run by
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- People needed
- 75
- Starts
- 2024-01-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-03-17
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Hospital Quironsalud Madrid — Pozuelo de Alarcón, Madrid, Spain (enrolling)
- Complejo Hospitalario La Coruña — A Coruña, Spain (enrolling)
- Hospital Clínico San Carlos — Madrid, Spain (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- Hospital Universitario Carlos Haya — Málaga, Spain (enrolling)
- Hospital Vírgen del Rocío — Seville, Spain (enrolling)
- Hospital Universitario y Politécnico La Fe — Valencia, Spain (enrolling)
Full record on ClinicalTrials.gov
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