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Safety and effect of mesenchymal derived Extracellular Vesicles in the prevention of Bronchopulmonary Dysplasia in extremely preterm newborns.
EU CTIS ID: 2022-500293-34-01
What this study is testing
Phase I primary objective To assess the acute and short-term safety of the intratracheal (IT) administration of EXOB-001 (single dose or multiple doses at different dose levels) at 36 weeks postmenstrual age (PMA). Phase II primary objective To assess the efficacy of EXOB-001 on the reduction of BPD grade II-III (modified NICHD severity grading case definition) at 36 weeks PMA as compared to a placebo group (saline solution).
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 anytime between at least 24 hours of life and 10 days postnatally or alternatively, needing re-intubation due to respiratory complications.
- Written informed consent from parents/legally designated representative
You likely can't join if
- Surfactant administration less than 12 hours prior to (first) IMP administration.
- 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 operating room) within 72 hours before or following baseline (phase I)/randomization (phase II)
- Has had a Grade 3 or 4 intraventricular haemorrhage
- Has active pulmonary haemorrhage
- Has periventricular leukomalacia
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 anytime between at least 24 hours of life and 10 days postnatally or alternatively, needing re-intubation due to respiratory complications.
- Written informed consent from parents/legally designated representative
- Surfactant administration less than 12 hours prior to (first) IMP administration.
- 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 operating room) within 72 hours before or following baseline (phase I)/randomization (phase II)
- Has had a Grade 3 or 4 intraventricular haemorrhage
- Has active pulmonary haemorrhage
- Has periventricular leukomalacia
- The subject is currently participating in any other interventional 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 during stabilization in the delivery room and for any reason(s) other than those listed above
- 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
- 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 major renal anomalies)
- Has had a known severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, human immunodeficiency virus, cytomegalovirus, etc.)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.