Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants Read More

Inclusion Criteria:

• Age: 5 - 14 days since birth
• Fetal gestational age: ≥23 weeks and <29 weeks
• Birth weight: ≥500g and ≤1250g
• Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of > 12 breath/min and > 25% oxygen
• Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment
• Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria:

• Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus
• Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
• Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
• Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
• Patient withCRP > 30 mg/dL; Severe sepsis or shock
• Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug
• Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug
• Patient with severe intracranial hemorrhage ≥ grade 3 or 4
• Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening
• Patient with a history of participating in other clinical studies
• Patient who is allergic to Gentamicin
• Patient who is considered inappropriate to participate in the study by the investigator