Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Clinical Trial to Stablish the Security of Using Allogeneic Fetal Stem Mesenchymal Cells From Umbilical Cord, Expanded in Pre-term Patients Suffering of Bronchopulmonary Dysplasia.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
75 participants
Jan 11, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
- 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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Interventions
Standard treatment
3 doses of 5 million MSC will be administered
6 doses of 5 million MSC will be administered
Locations(7)
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NCT06270199