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Clinical Trials/NCT01828957
NCT01828957CompletedPhase 2

Randomized, Double-blind, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pneumostem® Versus a Control Group for Treatment of Bronchopulmonary Dysplasia in Premature Infants

Medipost Co Ltd.2 sites in 1 country69 target enrollmentStarted: April 1, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
69
Locations
2
Primary Endpoint
Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
5 Days to 14 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age: 5 - 14 days since birth
  • •Fetal gestational age: ≥23 weeks and <29 weeks
  • •Birth weight: ≥500g and ≤1250g
  • •Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of > 12 breath/min and > 25% oxygen
  • •Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment
  • •Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria

  • •Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus
  • •Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
  • •Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
  • •Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
  • •Patient withCRP > 30 mg/dL; Severe sepsis or shock
  • •Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug
  • •Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug
  • •Patient with severe intracranial hemorrhage ≥ grade 3 or 4
  • •Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening
  • •Patient with a history of participating in other clinical studies
  • •Patient who is allergic to Gentamicin
  • •Patient who is considered inappropriate to participate in the study by the investigator

Arms & Interventions

Pneumostem®

Experimental

A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)

Intervention: Pneumostem® (Biological)

normal saline

Placebo Comparator

A single intratracheal administration of normal saline

Intervention: Normal Saline (Other)

Outcomes

Primary Outcomes

Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA

Time Frame: 36 weeks PMA

Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA

Secondary Outcomes

  • Cumulative duration of oxygen use(Week 24)
  • Incidence of BPD(28-days since birth)
  • Survival rate(28-days since birth, 36 weeks PMA, and termination of the trial)
  • Incidence of adverse events(Week 24)
  • Intubation duration(36 weeks PMA)
  • Duration of ventilator dependence(Week 24)
  • Incidence of Retinopathy of Prematurity (ROP) of Grade III or more(Week 24)
  • Retinopathy of Prematurity (ROP) that require treatment with avastin or laser(Week 24)
  • Postnatal steroid use (%) for the purpose of ventilator weaning(Week 24)
  • Length of stay prior to the first discharge from the hospital(duration of the hospital stay, an expected average of approximately 3 months since birth)
  • Duration of CPAP treatment(Week 24)
  • Growth velocity (Z-score)(Week 24)
  • Incidence of pneumothorax that require intubation(Week 24)
  • Clinically significant laboratory findings(Week 24)
  • Incidence of moderate to severe pulmonary hemorrhage(Week 24)
  • Incidence of intraventricular hemorrhage of grade 3 or more(Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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