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 (NCT01828957) 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: corrected age of 6, 12,18, 24, 36, 48, and 60 months.
Interventions
BIOLOGICALPneumostem®
BIOLOGICALnormal saline
Sponsors
Medipost Co Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Months to 7 Months
Healthy volunteers
No
Inclusion criteria
* Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial * 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 |
|---|---|
| Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection | 6, 12, 18, 24, 36, 48, and 60 months, corrected age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of admissions to Emergency Room | 6, 12, 18, 24, 36, 48, and 60 months, corrected age | Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems |
| Survival | 6, 12, 18, 24, 36, 48, and 60 months, corrected age | — |
| Growth measured by Z-score | 6, 12, 18, 24, 36, 48, and 60 months, corrected age | — |
| Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy | 24 months, corrected age | — |
| Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator) | 6, 12, 18, 24, 36, 48, and 60 months, corrected age | — |
| Number of adverse events | 6, 12, 24,36, 48, and 60 months, corrected age | — |
| Significant changes in vital signs | 6, 12, 24, 36, 48, and 60 months, corrected age | — |
| Significant changes in physical exam | 6, 12, 24, 36, 48, and 60 months, corrected age | — |
| Deafness or Blindness | 24 months, corrected age | — |
Countries
South Korea
Outcome results
None listed