A Phase 2 interventional study of PNEUMOSTEM® and normal saline in Bronchopulmonary Dysplasia and BPD, sponsored by Medipost Co Ltd.. Active, not recruiting at 2 sites in Korea, Republic of. Open to participants aged 6 Months to 60 Months. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Medipost Co Ltd. · Phase 2, Interventional, and Treatment
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
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →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.
Exclusion Criteria:
A single intratracheal administration of Pneumostem® (10.0 x 10\^6 cells/kg)
Biological: PNEUMOSTEM®
A single intratracheal administration of normal saline
Biological: normal saline
A single intratracheal administration of PNEUMOSTEM® (1.0 x 10\^7 cells/kg)
Also known as: Human umbilical cord blood-derived mesenchymal stem cells
A single intratracheal administration of normal saline
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 6 months corrected age
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 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
Time frame: 18 months corrected age
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 24 months corrected age
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 36 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 39 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 42 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 45 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 48 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 51 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 54 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 57 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time frame: 60 months after birth
Mortality
check whether patient is alive or dead at evaluation time point
Time frame: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Growth measured by Z-score
Growth measured by Z-score
Time frame: 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)
Neurological developmental status on 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
Deafness or Blindness
Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry
Time frame: 24 months corrected age
Bayley Scales of Infant and Toddler Development (Third Edition)
Scale: cognitive, motor, language, social-emotional, adaptive behavior
Time frame: 18~24months corrected age, 36~42months after birth
Gross Motor Function Classification System for Cerebral Palsy
Gross Motor Function Classification System for Cerebral Palsy
Time frame: 24 months corrected age
Number of adverse events
Number of adverse events
Time frame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Number of admissions to Emergency Room (ER)
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
Time frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Medical treatment records
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
Time frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Medipost Co Ltd.