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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828957
• Other study ID #: MP-CR-009
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: April 2017
• Source: Medipost Co Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth

Intervention

Biological:
• Pneumostem®

Other:
• Normal Saline

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medipost Co Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA	Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA	36 weeks PMA
Secondary	Intubation duration		36 weeks PMA
Secondary	Incidence of BPD		28-days since birth
Secondary	Survival rate		28-days since birth, 36 weeks PMA, and termination of the trial
Secondary	Duration of ventilator dependence		Week 24
Secondary	Duration of CPAP treatment		Week 24
Secondary	Postnatal steroid use (%) for the purpose of ventilator weaning		Week 24
Secondary	Cumulative duration of oxygen use		Week 24
Secondary	Incidence of Retinopathy of Prematurity (ROP) of Grade III or more		Week 24
Secondary	Retinopathy of Prematurity (ROP) that require treatment with avastin or laser		Week 24
Secondary	Growth velocity (Z-score)		Week 24
Secondary	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
Secondary	Incidence of adverse events		Week 24
Secondary	Clinically significant laboratory findings		Week 24
Secondary	Incidence of pneumothorax that require intubation		Week 24
Secondary	Incidence of moderate to severe pulmonary hemorrhage		Week 24
Secondary	Incidence of intraventricular hemorrhage of grade 3 or more		Week 24

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