Actively Recruiting
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
Led by EXO Biologics S.A. · Updated on 2024-09-19
265
Participants Needed
8
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- From birth up to 10 days chronological age
- Born between 23 weeks and 28 weeks plus 6 days gestational age
- Birth weight between 500 g and 1,500 g
- Endotracheally intubated and receiving mechanical ventilation with FiO2 greater than 25% between 3 and 10 days postnatally or needing re-intubation due to respiratory complications
- Not expected to be extubated within 24 to 48 hours after enrollment
- Written informed consent from parents or legally designated representative
You will not qualify if you...
- Surfactant administration less than 24 hours before first IMP administration
- Presence of congenital heart defect except patent ductus arteriosus, atrial septal defect, or small/moderate restrictive ventricular septal defect
- Serious lung malformation such as pulmonary hypoplasia/aplasia, congenital diaphragmatic hernia, or other congenital lung anomalies
- Currently treated with inhaled nitric oxide
- Known chromosomal abnormalities (e.g., Trisomy 18, 13, or 21) or severe congenital malformations (e.g., hydrocephalus, encephalocele, trachea-oesophageal fistula, abdominal wall defects, major renal anomalies)
- History of severe congenital infectious diseases (e.g., herpes, toxoplasmosis, rubella, syphilis, HIV, cytomegalovirus)
- Active systemic infection, severe sepsis, or septic shock at screening or baseline
- Surgical procedure requiring operating room admission within 72 hours before baseline or anticipated within 72 hours after baseline
- Grade 3 or 4 intraventricular hemorrhage
- Active pulmonary hemorrhage
- Periventricular leukomalacia
- Currently participating in another interventional clinical study
- Considered too ill by investigator due to factors such as death being inevitable or requiring thoracic compressions/adrenaline during delivery stabilization
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Cliniques Universitaires Saint-Luc (UCLouvain)
Brussels, Belgium, 1200
Not Yet Recruiting
2
ISPPC CHU Charleroi
Charleroi, Belgium, 6000
Not Yet Recruiting
3
Clinique CHC Montlégia
Liège, Belgium, 4000
Not Yet Recruiting
4
AOU Careggi
Florence, Italy
Active, Not Recruiting
5
IRCCS Instituto Giannina Gaslini
Genova, Italy
Actively Recruiting
6
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Active, Not Recruiting
7
AOU Policlinico di Modena
Modena, Italy
Not Yet Recruiting
8
Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova
Padua, Italy, 35128
Actively Recruiting
Research Team
B
Beatrice De Vos, M.D., Ph.D.
CONTACT
L
Lorine Preud'homme, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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