Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants - Trial NCT06279741
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.
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Study Focus
Sponsor & Location
EXO Biologics S.A.
Timeline & Enrollment
Phase 1/2
Dec 28, 2023
Dec 31, 2029
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
Data Source
ClinicalTrials.gov
NCT06279741
Non-Device Trial