Using extracellular vesicles to prevent lung disease in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 trial evaluates the safety and efficacy of EXOB-001, which consists of extracellular vesicles derived from umbilical cord mesenchymal stromal cells, in preventing bronchopulmonary dysplasia (BPD) in extremely premature infants. The study will involve infants born between 23 and 28 weeks of gestational age and weighing between 500g and 1,500g. Participants will receive one to three doses of EXOB-001 via endotracheal administration, with follow-up extending to two years of corrected age. The trial aims to determine the optimal dosage based on initial safety and efficacy results.

Why it matters

Who can join: the full rules

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 (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.).
* 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 (IVH).
* Has active pulmonary haemorrhage.
* Has periventricular leukomalacia (PVL).
* 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.

Where it's running

• IRCCS Instituto Giannina Gaslini
  Genova, Italy Recruiting
• Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova
  Padua, Italy Recruiting
• Cliniques Universitaires Saint-Luc (UCLouvain)
  Brussels, Belgium Not yet recruiting
• ISPPC CHU Charleroi
  Charleroi, Belgium Not yet recruiting
• Clinique CHC Montlégia
  Liège, Belgium Not yet recruiting
• AOU Careggi
  Florence, Italy Active not recruiting

Study contacts

• Study coordinator: Beatrice De Vos, M.D., Ph.D.
• Email: b.devos@exobio.be
• Phone: +32 478 88 26 57

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using IVIG to treat bronchopulmonary dysplasia in premature infants

  This study is testing if a special immune treatment called IVIG can help premature babies with breathing problems caused by bronchopulmonary dysplasia feel better.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.