PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants
- Conditions
- Severe Bronchopulmonary Dysplasia
- Interventions
- Other: Placebo
- Registration Number
- NCT03392467
- Lead Sponsor
- Medipost Co Ltd.
- 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 PNEUMOSTEM, while the other half will receive a placebo.
- 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 modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PNEUMOSTEM PNEUMOSTEM human umbilical cord blood derived mesenchymal stem cell (hUCB-MSC) Placebo Placebo normal saline
- Primary Outcome Measures
Name Time Method Percentage of subjects who have severe BPD or are dead 36 weeks postmenstrual age (PMA) Percentage of subjects who have severe BPD or are dead
- Secondary Outcome Measures
Name Time Method ventilation duration up to 24 weeks ventilation duration
Percentage of subjects in death due to lung disease prenatal 28 days/36 weeks PMA and study end timepoint Percentage of subjects in death due to lung disease
z-score up to 24 weeks (visit 10) percentile for body weight, height, and head circumference
days in hospitalization up to 24 weeks days in hospitalization
Percentage of subjects who have moderate/severe BPD or are dead 36 weeks PMA Percentage of subjects who have moderate/severe BPD or are dead
Percentage of subjects by severity of BPD prenatal 28 days/36 weeks PMA Percentage of subjects by severity of BPD
intubation duration up to 24 weeks intubation duration
continuous positive airway pressure (CPAP) treatment duration up to 24 weeks continuous positive airway pressure (CPAP) treatment duration
treatment duration with supplemental oxygen up to 24 weeks treatment duration with supplemental oxygen
% of subjects treated with steroid for weaning ventilator up to 24 weeks % of subjects treated with steroid for weaning ventilator
Retinopathy of prematurity (ROP) with stage III or higher up to 24 weeks number of subjects with ROP with stage III or higher
number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy up to 24 weeks number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy
changes in tracheal suction fluid examination from screening to 7 days after IP administration (visit 5) changes in tracheal suction fluid examination
Trial Locations
- Locations (2)
Asan medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of