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CompletedNCT01828957Updated Sep 6, 2019

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

A Phase 2 interventional study of Pneumostem® and Normal Saline in Bronchopulmonary Dysplasia, sponsored by Medipost Co Ltd.. Completed at 2 sites in Korea, Republic of. Open to participants aged 5 Days to 14 Days. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by Medipost Co Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
5 Days to 14 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchopulmonary Dysplasia

Keywords

  • Human Umbilical Cord Blood Derived Mesenchymal Stem Cells
  • Bronchopulmonary dysplasia
  • Premature infants
03

In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's enrollment of 69 is close to the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

Medipost Co Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Days to 14 Days
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Pneumostem®

    A single intratracheal administration of Pneumostem® (1.0 x 10\^7 cells/kg)

    Biological: Pneumostem®

  • Placebo comparator
    normal saline

    A single intratracheal administration of normal saline

    Other: Normal Saline

Interventions

  • BiologicalPneumostem®

    Also known as: Human umbilical cord blood-derived mesenchymal stem cells

  • OtherNormal Saline
06

What researchers measure

Primary outcomes

  1. Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA

    Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA

    Time frame: 36 weeks PMA

Secondary outcomes

  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

07

Study locations

2 sites
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Ahn SY, Chang YS, Lee MH, Sung SI, Lee BS, Kim KS, Kim AR, Park WS. Stem cells for bronchopulmonary dysplasia in preterm infants: A randomized controlled phase II trial. Stem Cells Transl Med. 2021 Aug;10(8):1129-1137. doi: 10.1002/sctm.20-0330. Epub 2021 Apr 20. PubMed 33876883 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01828957
Lead sponsor
Medipost Co Ltd.
Responsible party
Sponsor
First posted
Apr 11, 2013
Start date
Apr 2013
Primary completion
May 2015
Completion
Aug 2015
Last update
Sep 6, 2019

Study contacts

Won-Soon Park, MD, PhD
principal investigator · Department of Pediatrics, Samsung Medical Center
Ai-Rhan Kim
principal investigator · Department of Neonatology, Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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