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

NCT03392467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

  • Severe Bronchopulmonary Dysplasia

Interventions

BIOLOGICAL

PNEUMOSTEM

human umbilical cord blood-derived mesenchymal stem cells

OTHER

Placebo

normal saline

Sponsors & Collaborators

  • Medipost Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Wonsoon Park · Samsung Medical Center

  • Airhan Kim · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
13 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2024-01-09
Completion
2024-10-18

Countries

  • South Korea

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 NCT03392467 on ClinicalTrials.gov