BPD, Bronchopulmonary Dysplasia
Conditions
Keywords
Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants
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
Detailed description
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.
Interventions
BIOLOGICALPNEUMOSTEM®
A single intratracheal administration of PNEUMOSTEM® (1.0 x 10\^7 cells/kg)
BIOLOGICALnormal saline
A single intratracheal administration of normal saline
Sponsors
Medipost Co Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory outcome: Number of hospitalizations | 6 months corrected age | Total number of hospitalizations and the number of hospital stay due to respiratory infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth measured by Z-score | 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth | Growth measured by Z-score |
| 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 | Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST) |
| Deafness or Blindness | 24 months corrected age | Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry |
| Bayley Scales of Infant and Toddler Development (Third Edition) | 18~24months corrected age, 36~42months after birth | Scale: cognitive, motor, language, social-emotional, adaptive behavior |
| Mortality | 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 |
| Number of adverse events | 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth | Number of adverse events |
| Number of admissions to Emergency Room (ER) | 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 |
| Medical treatment records | 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 |
| Gross Motor Function Classification System for Cerebral Palsy | 24 months corrected age | Gross Motor Function Classification System for Cerebral Palsy |
Countries
South Korea
Outcome results
None listed