Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study

Inclusion Criteria:

- A male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment
between 5 and 14 days after birth)

- A subject whose gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age
(GA) < 28 weeks)

- A subject whose birth weight is between 500g and 1000g, inclusive

- A subject who is intubated and receiving mechanical ventilation within 5-14 days after
birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening

- A subject who has had either a deterioration or no change in the setting of mechanical
ventilation within the 24 hours before trial enrollment

- A subject whose parent/guardian can give a written informed consent

Exclusion Criteria:

- A subject who has a congenital heart defect, except for patent ductus arteriosus
(PDA), atrial septal defect (ASD) or a small, restrictive ventricular septal defect
(VSD)

- A subject who has a serious malformation of the lung such as pulmonary
hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly

- A subject who has a chromosomal abnormality (e.g., Trisomy 18, Trisomy 13 or Trisomy
21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele,
tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies)

- A subject who has had a severe congenital infectious disease (i.e., herpes,
toxoplasmosis rubella, syphilis, HIV, etc.)

- A subject who has evidence of severe sepsis or septic shock due to an active infection
at Screening

- A subject who underwent a surgical procedure within 72 hours before study drug
administration or who is anticipated to have a surgical procedure within 72 hours
before or following study drug administration

- A subject who was administered surfactant within 24 hours before study drug
administration

- A subject who has had a bilateral grade 3 or 4 intracranial hemorrhage

- A subject who has active pulmonary hemorrhage or an active air leak syndrome at
Screening

- A subject who is currently participating in any other interventional clinical trial

- A subject who is, in the opinion of the Principal Investigator, considered
inappropriate for the trial due to any reasons other than those listed above