Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
Phase 2
Completed
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Biological: Pneumostem®Other: Normal Saline
- Registration Number
- NCT01828957
- Lead Sponsor
- Medipost Co Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pneumostem® Pneumostem® A single intratracheal administration of Pneumostem® (1.0 x 10\^7 cells/kg) normal saline Normal Saline A single intratracheal administration of normal saline
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Survival rate 28-days since birth, 36 weeks PMA, and termination of the trial Incidence of adverse events Week 24 Intubation duration 36 weeks PMA Duration of ventilator dependence Week 24 Incidence of Retinopathy of Prematurity (ROP) of Grade III or more Week 24 Retinopathy of Prematurity (ROP) that require treatment with avastin or laser Week 24 Postnatal steroid use (%) for the purpose of ventilator weaning Week 24 Cumulative duration of oxygen use 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 Duration of CPAP treatment Week 24 Growth velocity (Z-score) Week 24 Incidence of pneumothorax that require intubation Week 24 Incidence of BPD 28-days since birth Clinically significant laboratory findings Week 24 Incidence of moderate to severe pulmonary hemorrhage Week 24 Incidence of intraventricular hemorrhage of grade 3 or more Week 24
Trial Locations
- Locations (2)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of