Status:
COMPLETED
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
Lead Sponsor:
Medipost Co Ltd.
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
5-14 years
Phase:
PHASE2
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 infa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01828957
Start Date
April 1 2013
End Date
August 1 2015
Last Update
September 6 2019
Active Locations (2)
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1
Asan Medical Center
Seoul, South Korea
2
Samsung Medical Center
Seoul, South Korea