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Prevention study for Bronchopulmonary Dysplasia
Official title Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
ClinicalTrials.gov ID: NCT06279741
What this study is testing
What is Endotracheopulmonary Instillation, Suspension?
Endotracheopulmonary Instillation, Suspension is an investigational medicine, being studied as a potential treatment for bronchopulmonary dysplasia.
Also referred to as Endotracheopulmonary instillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 10
You may be able to join if
- 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...
- Written informed consent from parents/legally designated representative.
You likely can't join if
- 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...
- 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 (e.g., Trisomy 18, Trisomy 13, or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and...
- Has had a known severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, human immunodeficiency virus, cytomegalovirus...
See the full eligibility 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...
- Written informed consent from parents/legally designated representative.
- 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 (e.g., Trisomy 18, Trisomy 13, or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, trachea-oesophageal fistula, abdominal wall defects, and...
- Has had a known severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, human immunodeficiency virus, cytomegalovirus, etc.).
- Active systemic infection, severe sepsis, or septic shock at Screening up to baseline (phase I) or randomization (phase II).
- Underwent a surgical procedure (requiring admission to an operating room) within 72 hours before baseline (phase I)/randomization (phase II) or who is anticipated to have a surgical procedure (requiring admission to an...
- Has had a Grade 3 or 4 intraventricular haemorrhage (IVH).
- Has active pulmonary haemorrhage.
- Has periventricular leukomalacia (PVL).
- The subject is currently participating in any other treatment clinical study.
- The subject is, in the opinion of the Investigator, so ill that death is inevitable, or is considered inappropriate for the study such as an infant that received thoracic compressions and/or adrenaline administration...
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Charleroi, Belgium
- Liège, Belgium
- Florence, Italy
- Genova, Italy
- Milan, Italy
- Modena, Italy
- Padua, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 10 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Charleroi, Belgium; Liège, Belgium; Florence, Italy; Genova, Italy; Milan, Italy and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.