Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Medipost Co Ltd. Identifier:
First received: April 2, 2013
Last updated: April 18, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Bronchopulmonary Dysplasia
Biological: Pneumostem®
Other: Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA [ Time Frame: 36 weeks PMA ]
    Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: April 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumostem®
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
Biological: Pneumostem®
Other Name: Human umbilical cord blood-derived mesenchymal stem cells
Placebo Comparator: normal saline
A single intratracheal administration of normal saline
Other: Normal Saline


Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01828957

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Medipost Co Ltd.
Principal Investigator: Won-Soon Park, MD, PhD Department of Pediatrics, Samsung Medical Center
Principal Investigator: Ai-Rhan Kim Department of Neonatology, Asan Medical Center
  More Information

Additional Information:
Responsible Party: Medipost Co Ltd. Identifier: NCT01828957     History of Changes
Other Study ID Numbers: MP-CR-009
Study First Received: April 2, 2013
Last Updated: April 18, 2017

Keywords provided by Medipost Co Ltd.:
Human Umbilical Cord Blood Derived Mesenchymal Stem Cells
Bronchopulmonary dysplasia
Premature infants

Additional relevant MeSH terms:
Premature Birth
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases processed this record on May 23, 2017