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

RecruitingPhase 2Ages 1 Month - 28 WeeksAllFundacion para la Investigacion Biomedica del Hos…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

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

7 sites
Hospital Quironsalud Madrid
Pozuelo de Alarcón, Spain
Complejo Hospitalario La Coruña
A Coruña, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Carlos Haya
Málaga, Spain
Hospital Vírgen del Rocío
Seville, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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