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 PNEUMOSTEM, while the other half will receive a placebo.
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 modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
human umbilical cord blood-derived mesenchymal stem cells
normal saline
Asan medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Percentage of subjects who have severe BPD or are dead
Percentage of subjects who have severe BPD or are dead
Time frame: 36 weeks postmenstrual age (PMA)
Percentage of subjects who have moderate/severe BPD or are dead
Percentage of subjects who have moderate/severe BPD or are dead
Time frame: 36 weeks PMA
Percentage of subjects by severity of BPD
Percentage of subjects by severity of BPD
Time frame: prenatal 28 days/36 weeks PMA
Percentage of subjects in death due to lung disease
Percentage of subjects in death due to lung disease
Time frame: prenatal 28 days/36 weeks PMA and study end timepoint
intubation duration
intubation duration
Time frame: up to 24 weeks
ventilation duration
ventilation duration
Time frame: up to 24 weeks
continuous positive airway pressure (CPAP) treatment duration
continuous positive airway pressure (CPAP) treatment duration
Time frame: up to 24 weeks
treatment duration with supplemental oxygen
treatment duration with supplemental oxygen
Time frame: up to 24 weeks
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% of subjects treated with steroid for weaning ventilator
% of subjects treated with steroid for weaning ventilator
Time frame: up to 24 weeks
Retinopathy of prematurity (ROP) with stage III or higher
number of subjects with ROP with stage III or higher
Time frame: up to 24 weeks
number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy
number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy
Time frame: up to 24 weeks
z-score
percentile for body weight, height, and head circumference
Time frame: up to 24 weeks (visit 10)
days in hospitalization
days in hospitalization
Time frame: up to 24 weeks
changes in tracheal suction fluid examination
changes in tracheal suction fluid examination
Time frame: from screening to 7 days after IP administration (visit 5)