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

NCT06279741 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2024-09-19

No results posted yet for this study

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).

Conditions

  • Bronchopulmonary Dysplasia

Interventions

BIOLOGICAL

Endotracheopulmonary Instillation, Suspension

The endotracheal administration can be either by endotracheal tube instillation using a 5 French end-hole catheter or by endotracheal tube instillation using the secondary lumen of a dual lumen endotracheal tube. The dose is adjusted to body weight and the endotracheal administration will be performed in an already intubated newborn infant.

Sponsors & Collaborators

  • EXO Biologics S.A.

    lead INDUSTRY

Principal Investigators

  • Beatrice De Vos, M.D., Ph.D. · EXO Biologics SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2027-01-31
Completion
2029-12-31

Countries

  • Belgium
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279741 on ClinicalTrials.gov