NCT03392467

Brief Summary

This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
Last Updated

January 24, 2025

Status Verified

March 1, 2024

Enrollment Period

5.4 years

First QC Date

December 20, 2017

Last Update Submit

January 22, 2025

Conditions

Severe Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects who have severe BPD or are dead

    Percentage of subjects who have severe BPD or are dead

    36 weeks postmenstrual age (PMA)

Secondary Outcomes (13)

  • Percentage of subjects who have moderate/severe BPD or are dead

    36 weeks PMA

  • Percentage of subjects by severity of BPD

    prenatal 28 days/36 weeks PMA

  • Percentage of subjects in death due to lung disease

    prenatal 28 days/36 weeks PMA and study end timepoint

  • intubation duration

    up to 24 weeks

  • ventilation duration

    up to 24 weeks

  • +8 more secondary outcomes

Study Arms (2)

PNEUMOSTEM

EXPERIMENTAL

human umbilical cord blood derived mesenchymal stem cell (hUCB-MSC)

Biological: PNEUMOSTEM

Placebo

PLACEBO COMPARATOR

normal saline

Other: Placebo

Interventions

PNEUMOSTEMBIOLOGICAL

human umbilical cord blood-derived mesenchymal stem cells

PNEUMOSTEM
PlaceboOTHER

normal saline

Placebo

Eligibility Criteria

AgeUp to 13 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • at screening and randomization
  • weeks to \< 25 weeks of gestational age
  • g to 1,250g body weight at birth
  • premature infant within postnatal 13 days of age
  • use ventilator with ventilation rate \>12 breaths/min or oxygen supply \> 25%, or use high frequency ventilator (HFV)
  • at IP administration
  • premature infant within postnatal 5 to 14 days of age
  • No improvement in ventilator setting 24 hours prior to administration of IP

You may not qualify if:

  • subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure
  • subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease
  • subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
  • subject with serious sepsis as active infection or shock due to sepsis
  • subject with grade 3 or 4 of bilateral intraventricular hemorrhage
  • at screening, subject with active pulmonary hemorrhage or active air leak syndrome
  • subject who underwent/will undergo surgery within 72 hours before/after investigational product (IP) administration
  • subject who is expected to be treated with surfactant within 24 hours prior to IP administration
  • subject who is expected to be allergic to gentamicin (Birth mother's allergy for gentamicin will be confirmed).
  • subject who have previously participated in other clinical trials
  • subject who is considered ineligible by investigator due to other medical reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33876883DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Wonsoon Park

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Airhan Kim

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 8, 2018

Study Start

August 13, 2018

Primary Completion

January 9, 2024

Study Completion

October 18, 2024

Last Updated

January 24, 2025

Record last verified: 2024-03

Locations

KR(2)