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NCT06279741

Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants

Phase I Single Arm, Dose Escalating and Phase II Double Blind, Randomized, Placebo-controlled, Dose Finding Clinical Trial Assessing Safety and Efficacy of Intratracheal Administration of Allogeneic Umbilical Cord Mesenchymal Cells-derived Extracellular Vesicles in Preventing Bronchopulmonary Dysplasia in Extremely Preterm Newborns
EXO Biologics S.A.·Phase 1/2·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Bronchopulmonary Dysplasia
Drug/Device/Intervention
Endotracheopulmonary Instillation, Suspension
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
EXO Biologics S.A.
Location
Brussels,Charleroi,Liège,Florence,Genova,Milan,Modena,Padua, Belgium,Italy
Timeline & enrollment
Phase
Phase 1/2
Start date
Dec 28, 2023
End date
Dec 31, 2029
Enrollment
265 participants
Primary outcome

Number of subjects with treatment-emergent adverse events (phase 1),Number of subjects with BPD grade II-III incidence rate per groups (phase 2).

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).

ICD-10 classifications
Bronchopulmonary dysplasia originating in the perinatal periodCongenital bronchomalaciaBronchopneumonia, unspecifiedOther congenital malformations of bronchusDiseases of bronchus, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06279741
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06279741 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by EXO Biologics S.A. and is currently Recruiting. The study focuses on Bronchopulmonary Dysplasia. Target enrollment is 265 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.