NCT04003857

Brief Summary

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age

Trial Health

75
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
14mo left

Started Jul 2019

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Study Progress86%
Jul 2019Jun 2027

First Submitted

Initial submission to the registry

June 19, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

8 years

First QC Date

June 19, 2019

Last Update Submit

February 4, 2025

Conditions

Bronchopulmonary DysplasiaBPD

Keywords

Human Umbilical Cord Blood Derived Mesenchymal Stem CellsBronchopulmonary dysplasiaPremature infants

Outcome Measures

Primary Outcomes (13)

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    6 months corrected age

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    12 months corrected age

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group

    18 months corrected age

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    24 months corrected age

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    36 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    39 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    42 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    45 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    48 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    51 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    54 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    57 months after birth

  • Respiratory outcome: Number of hospitalizations

    Total number of hospitalizations and the number of hospital stay due to respiratory infection

    60 months after birth

Secondary Outcomes (9)

  • Mortality

    6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth

  • Growth measured by Z-score

    6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth

  • Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)

    6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth

  • Deafness or Blindness

    24 months corrected age

  • Bayley Scales of Infant and Toddler Development (Third Edition)

    18~24months corrected age, 36~42months after birth

  • +4 more secondary outcomes

Study Arms (2)

PNEUMOSTEM®

EXPERIMENTAL

A single intratracheal administration of Pneumostem® (10.0 x 10\^6 cells/kg)

Biological: PNEUMOSTEM®

normal saline

PLACEBO COMPARATOR

A single intratracheal administration of normal saline

Biological: normal saline

Interventions

PNEUMOSTEM®BIOLOGICAL

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

Also known as: Human umbilical cord blood-derived mesenchymal stem cells
PNEUMOSTEM®
normal salineBIOLOGICAL

A single intratracheal administration of normal saline

normal saline

Eligibility Criteria

Age6 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
  • Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

You may not qualify if:

  • Subject whose parent or legal representative does not agree to participate in the study
  • Subject who is considered inappropriate to participate in the study by the investigator

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

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature Birth

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Wonsoon Park, MD, PhD

    Department of Pediatrics, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Ai-Rhan Kim, MD, PhD

    Department of Neonatology, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 19, 2019

First Posted

July 1, 2019

Study Start

July 5, 2019

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)