Status:
COMPLETED
PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants
Lead Sponsor:
Medipost Co Ltd.
Conditions:
Severe Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 13 years
Phase:
PHASE2
Brief Summary
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive ...
Detailed Description
Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulati...
Eligibility Criteria
Inclusion
- at screening and randomization
- 23 weeks to \< 25 weeks of gestational age
- 500g to 1,250g body weight at birth
- premature infant within postnatal 13 days of age
- use ventilator with ventilation rate \>12 breaths/min or oxygen supply \> 25%, or use high frequency ventilator (HFV)
- at IP administration
- premature infant within postnatal 5 to 14 days of age
- No improvement in ventilator setting 24 hours prior to administration of IP
Exclusion
- subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure
- subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease
- subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
- subject with serious sepsis as active infection or shock due to sepsis
- subject with grade 3 or 4 of bilateral intraventricular hemorrhage
- at screening, subject with active pulmonary hemorrhage or active air leak syndrome
- subject who underwent/will undergo surgery within 72 hours before/after investigational product (IP) administration
- subject who is expected to be treated with surfactant within 24 hours prior to IP administration
- subject who is expected to be allergic to gentamicin (Birth mother's allergy for gentamicin will be confirmed).
- subject who have previously participated in other clinical trials
- subject who is considered ineligible by investigator due to other medical reasons
Key Trial Info
Start Date :
August 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03392467
Start Date
August 13 2018
End Date
October 18 2024
Last Update
January 24 2025
Active Locations (2)
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1
Asan medical Center
Seoul, South Korea
2
Samsung Medical Center
Seoul, South Korea