Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pneumostem®

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

Group Type EXPERIMENTAL

Pneumostem®

Intervention Type BIOLOGICAL

normal saline

A single intratracheal administration of normal saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

Interventions

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Pneumostem®

Intervention Type BIOLOGICAL

Normal Saline

Intervention Type OTHER

Other Intervention Names

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Human umbilical cord blood-derived mesenchymal stem cells

Eligibility Criteria

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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

Minimum Eligible Age

5 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No