NCT06279741 Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
| NCT ID | NCT06279741 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | EXO Biologics S.A. |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 265 participants |
| Start Date | 2023-12-28 |
| Primary Completion | 2027-01-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution). Infants will be followed up to 2 years of corrected age (end of study).
Eligibility Criteria
Inclusion Criteria: * From birth up to 10 days chronological age. * From 23 weeks up to 28 weeks (27 week+6 days) gestational age at birth. * Birth weight ≥ 500g but ≤1500g. * Endotracheally intubated and receiving mechanical ventilation with FiO2 \> 25% anytime between 3 and 10 days postnatally or needing re-intubation due to respiratory complications, - Not expected to be extubated within the next 24/48 hours after enrolment. * Written informed consent from parents/legally designated representative. Exclusion Criteria: * Surfactant administration less than 24 hours prior to (first) IMP administration. * Has a congenital heart defect, except for patent ductus arteriosus (PDA), atrial septal defect or a small/moderate, restrictive ventricular septal defect. * Has a serious malformation of the lung, such as pulmonary hypoplasia/aplasia, congenital diaphragmatic hernia, or any other congenital lung anomaly. * Being treated with inhaled nitric oxide. * Has a known chromosomal abnormality