PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants

  • STATUS
    Recruiting
  • End date
    Mar 6, 2024
  • participants needed
    60
  • sponsor
    Medipost Co Ltd.
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Updated on 6 April 2023
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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.

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.

Details
Condition Severe Bronchopulmonary Dysplasia
Treatment Placebo, Pneumostem
Clinical Study IdentifierNCT03392467
SponsorMedipost Co Ltd.
Last Modified on6 April 2023

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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