This trial is active, not recruiting.

Condition bronchopulmonary dysplasia
Treatments pneumostem®, normal saline
Phase phase 2
Sponsor Medipost Co Ltd.
Start date April 2013
End date June 2016
Trial size 70 participants
Trial identifier NCT01828957, MP-CR-009


The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
pneumostem® Human umbilical cord blood-derived mesenchymal stem cells
(Placebo Comparator)
A single intratracheal administration of normal saline
normal saline Normal Saline

Primary Outcomes

Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA
time frame: 36 weeks PMA

Secondary Outcomes

Intubation duration
time frame: 36 weeks PMA
Incidence of BPD
time frame: 28-days since birth
Survival rate
time frame: 28-days since birth, 36 weeks PMA, and termination of the trial
Duration of ventilator dependence
time frame: Week 24
Duration of CPAP treatment
time frame: Week 24
Postnatal steroid use (%) for the purpose of ventilator weaning
time frame: Week 24
Cumulative duration of oxygen use
time frame: Week 24
Incidence of Retinopathy of Prematurity (ROP) of Grade III or more
time frame: Week 24
Retinopathy of Prematurity (ROP) that require treatment with avastin or laser
time frame: Week 24
Growth velocity (Z-score)
time frame: Week 24
Length of stay prior to the first discharge from the hospital
time frame: duration of the hospital stay, an expected average of approximately 3 months since birth
Incidence of adverse events
time frame: Week 24
Clinically significant laboratory findings
time frame: Week 24
Incidence of pneumothorax that require intubation
time frame: Week 24
Incidence of moderate to severe pulmonary hemorrhage
time frame: Week 24
Incidence of intraventricular hemorrhage of grade 3 or more
time frame: Week 24

Eligibility Criteria

Male or female participants up to 14 days old.

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

Additional Information

Official title Randomized, Double-blind, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pneumostem® Versus a Control Group for Treatment of Bronchopulmonary Dysplasia in Premature Infants
Principal investigator Won-Soon Park, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Medipost Co Ltd..