Bronchopulmonary Dysplasia
Conditions
Keywords
Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants
Brief summary
The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
Interventions
BIOLOGICALPneumostem®
OTHERNormal Saline
Sponsors
Medipost Co Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
* Age: 5 - 14 days since birth * Fetal gestational age: ≥23 weeks and \<29 weeks * Birth weight: ≥500g and ≤1250g * Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of \> 12 breath/min and \> 25% oxygen * Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment * Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial
Exclusion criteria
* Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus * Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease) * Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc) * Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc) * Patient withCRP \> 30 mg/dL; Severe sepsis or shock * Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug * Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug * Patient with severe intracranial hemorrhage ≥ grade 3 or 4 * Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening * Patient with a history of participating in other clinical studies * Patient who is allergic to Gentamicin * Patient who is considered inappropriate to participate in the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA | 36 weeks PMA | Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of BPD | 28-days since birth |
| Survival rate | 28-days since birth, 36 weeks PMA, and termination of the trial |
| Duration of ventilator dependence | Week 24 |
| Duration of CPAP treatment | Week 24 |
| Postnatal steroid use (%) for the purpose of ventilator weaning | Week 24 |
| Cumulative duration of oxygen use | Week 24 |
| Incidence of Retinopathy of Prematurity (ROP) of Grade III or more | Week 24 |
| Intubation duration | 36 weeks PMA |
| Growth velocity (Z-score) | Week 24 |
| Length of stay prior to the first discharge from the hospital | duration of the hospital stay, an expected average of approximately 3 months since birth |
| Incidence of adverse events | Week 24 |
| Clinically significant laboratory findings | Week 24 |
| Incidence of pneumothorax that require intubation | Week 24 |
| Incidence of moderate to severe pulmonary hemorrhage | Week 24 |
| Incidence of intraventricular hemorrhage of grade 3 or more | Week 24 |
| Retinopathy of Prematurity (ROP) that require treatment with avastin or laser | Week 24 |
Countries
South Korea
Outcome results
None listed