NCT03392467

PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia in Premature Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 13 Days
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.

Detailed description

Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.

Conditions

• Severe Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
BIOLOGICAL	PNEUMOSTEM	human umbilical cord blood-derived mesenchymal stem cells
OTHER	Placebo	normal saline

Timeline

• Start date: 2018-08-13
• Primary completion: 2024-01-09
• Completion: 2024-10-18
• First posted: 2018-01-08
• Last updated: 2025-01-24

Locations

2 sites across 1 country: South Korea