Overview

This trial has been completed.

Condition bronchopulmonary dysplasia
Treatments pneumostem®, normal saline
Phase phase 2
Sponsor Medipost Co Ltd.
Start date April 2013
End date August 2015
Trial size 70 participants
Trial identifier NCT01828957, MP-CR-009

Summary

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
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator, outcomes assessor
Arm
(Experimental)
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

Primary Outcomes

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

Secondary Outcomes

Measure
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

All 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 2017.
Information provided to ClinicalTrials.gov by Medipost Co Ltd..