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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01828957
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Medipost Co Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Biological: Pneumostem® Other: Normal Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Intubation duration [ Time Frame: 36 weeks PMA ]
  2. Incidence of BPD [ Time Frame: 28-days since birth ]
  3. Survival rate [ Time Frame: 28-days since birth, 36 weeks PMA, and termination of the trial ]
  4. Duration of ventilator dependence [ Time Frame: Week 24 ]
  5. Duration of CPAP treatment [ Time Frame: Week 24 ]
  6. Postnatal steroid use (%) for the purpose of ventilator weaning [ Time Frame: Week 24 ]
  7. Cumulative duration of oxygen use [ Time Frame: Week 24 ]
  8. Incidence of Retinopathy of Prematurity (ROP) of Grade III or more [ Time Frame: Week 24 ]
  9. Retinopathy of Prematurity (ROP) that require treatment with avastin or laser [ Time Frame: Week 24 ]
  10. Growth velocity (Z-score) [ Time Frame: Week 24 ]
  11. 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 ]
  12. Incidence of adverse events [ Time Frame: Week 24 ]
  13. Clinically significant laboratory findings [ Time Frame: Week 24 ]
  14. Incidence of pneumothorax that require intubation [ Time Frame: Week 24 ]
  15. Incidence of moderate to severe pulmonary hemorrhage [ Time Frame: Week 24 ]
  16. Incidence of intraventricular hemorrhage of grade 3 or more [ Time Frame: Week 24 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Days 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01828957

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Medipost Co Ltd.
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Principal Investigator: Won-Soon Park, MD, PhD Department of Pediatrics, Samsung Medical Center
Principal Investigator: Ai-Rhan Kim Department of Neonatology, Asan Medical Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medipost Co Ltd. Identifier: NCT01828957    
Other Study ID Numbers: MP-CR-009
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: April 2017
Keywords provided by Medipost Co Ltd.:
Human Umbilical Cord Blood Derived Mesenchymal Stem Cells
Bronchopulmonary dysplasia
Premature infants
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases