PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants
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ClinicalTrials.gov Identifier: NCT03392467 |
Recruitment Status :
Recruiting
First Posted : January 8, 2018
Last Update Posted : August 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Bronchopulmonary Dysplasia | Biological: PNEUMOSTEM Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia in Premature Infants |
Actual Study Start Date : | August 13, 2018 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: PNEUMOSTEM
human umbilical cord blood derived mesenchymal stem cell (hUCB-MSC)
|
Biological: PNEUMOSTEM
human umbilical cord blood-derived mesenchymal stem cells |
Placebo Comparator: Placebo
normal saline
|
Other: Placebo
normal saline |
- Percentage of subjects who have severe BPD or are dead [ Time Frame: 36 weeks postmenstrual age (PMA) ]Percentage of subjects who have severe BPD or are dead
- Percentage of subjects who have moderate/severe BPD or are dead [ Time Frame: 36 weeks PMA ]Percentage of subjects who have moderate/severe BPD or are dead
- Percentage of subjects by severity of BPD [ Time Frame: prenatal 28 days/36 weeks PMA ]Percentage of subjects by severity of BPD
- Percentage of subjects in death due to lung disease [ Time Frame: prenatal 28 days/36 weeks PMA and study end timepoint ]Percentage of subjects in death due to lung disease
- intubation duration [ Time Frame: up to 24 weeks ]intubation duration
- ventilation duration [ Time Frame: up to 24 weeks ]ventilation duration
- continuous positive airway pressure (CPAP) treatment duration [ Time Frame: up to 24 weeks ]continuous positive airway pressure (CPAP) treatment duration
- treatment duration with supplemental oxygen [ Time Frame: up to 24 weeks ]treatment duration with supplemental oxygen
- % of subjects treated with steroid for weaning ventilator [ Time Frame: up to 24 weeks ]% of subjects treated with steroid for weaning ventilator
- Retinopathy of prematurity (ROP) with stage III or higher [ Time Frame: 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 [ Time Frame: up to 24 weeks ]number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy
- z-score [ Time Frame: up to 24 weeks (visit 10) ]percentile for body weight, height, and head circumference
- days in hospitalization [ Time Frame: up to 24 weeks ]days in hospitalization
- changes in tracheal suction fluid examination [ Time Frame: from screening to 7 days after IP administration (visit 5) ]changes in tracheal suction fluid examination

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Ages Eligible for Study: | up to 13 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392467
Contact: Eunyoung Lee | 82234656748 | ley0113@medi-post.co.kr |
Korea, Republic of | |
Asan medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: Airhan Kim, MD | |
Principal Investigator: Airhan Kim, MD | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: Wonsoon Park, MD | |
Principal Investigator: Wonsoon Park, MD |
Principal Investigator: | Wonsoon Park | Samsung Medical Center | |
Principal Investigator: | Airhan Kim | Asan Medical Center |
Responsible Party: | Medipost Co Ltd. |
ClinicalTrials.gov Identifier: | NCT03392467 |
Other Study ID Numbers: |
MP-CR-012 |
First Posted: | January 8, 2018 Key Record Dates |
Last Update Posted: | August 28, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bronchopulmonary Dysplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |