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Active, Not Recruiting

NCT Number: NCT04003857

Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bronchopulmonary Dysplasia BPD Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

About this study

Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PNEUMOSTEM®

Biological

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

Other names: Human umbilical cord blood-derived mesenchymal stem cells

Normal Saline

Biological

A single intratracheal administration of normal saline

Primary outcomes

  1. Respiratory outcome: Number of hospitalizations

    Time frame: 6 months corrected age

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

  2. Respiratory outcome: Number of hospitalizations

    Time frame: 12 months corrected age

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

  3. Respiratory outcome: Number of hospitalizations

    Time frame: 18 months corrected age

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

  4. Respiratory outcome: Number of hospitalizations

    Time frame: 24 months corrected age

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

  5. Respiratory outcome: Number of hospitalizations

    Time frame: 36 months after birth

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

  6. Respiratory outcome: Number of hospitalizations

    Time frame: 39 months after birth

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

  7. Respiratory outcome: Number of hospitalizations

    Time frame: 42 months after birth

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

  8. Respiratory outcome: Number of hospitalizations

    Time frame: 45 months after birth

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

  9. Respiratory outcome: Number of hospitalizations

    Time frame: 48 months after birth

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

  10. Respiratory outcome: Number of hospitalizations

    Time frame: 51 months after birth

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

  11. Respiratory outcome: Number of hospitalizations

    Time frame: 54 months after birth

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

  12. Respiratory outcome: Number of hospitalizations

    Time frame: 57 months after birth

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

  13. Respiratory outcome: Number of hospitalizations

    Time frame: 60 months after birth

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

Secondary outcomes

  1. Mortality

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

    check whether patient is alive or dead at evaluation time point

  2. Growth measured by Z-score

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

    Growth measured by Z-score

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

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

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

  4. Deafness or Blindness

    Time frame: 24 months corrected age

    Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry

  5. Bayley Scales of Infant and Toddler Development (Third Edition)

    Time frame: 18~24months corrected age, 36~42months after birth

    Scale: cognitive, motor, language, social-emotional, adaptive behavior

  6. Gross Motor Function Classification System for Cerebral Palsy

    Time frame: 24 months corrected age

    Gross Motor Function Classification System for Cerebral Palsy

  7. Number of adverse events

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

    Number of adverse events

  8. Number of admissions to Emergency Room (ER)

    Time frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth

    Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point

  9. Medical treatment records

    Time frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth

    whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point

Sponsors and collaborators

Lead sponsor

Medipost Co Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2019
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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