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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medipost Co Ltd.
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT01828957
First received: April 2, 2013
Last updated: November 1, 2013
Last verified: November 2013

April 2, 2013
November 1, 2013
April 2013
June 2016   (final data collection date for primary outcome measure)
Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA [ Time Frame: 36 weeks PMA ] [ Designated as safety issue: No ]
Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA
Same as current
Complete list of historical versions of study NCT01828957 on ClinicalTrials.gov Archive Site
  • Intubation duration [ Time Frame: 36 weeks PMA ] [ Designated as safety issue: No ]
  • Incidence of BPD [ Time Frame: 28-days since birth ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: 28-days since birth, 36 weeks PMA, and termination of the trial ] [ Designated as safety issue: No ]
  • Duration of ventilator dependence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Duration of CPAP treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Postnatal steroid use (%) for the purpose of ventilator weaning [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Cumulative duration of oxygen use [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Incidence of Retinopathy of Prematurity (ROP) of Grade III or more [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Retinopathy of Prematurity (ROP) that require treatment with avastin or laser [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Growth velocity (Z-score) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Length of stay prior to the first discharge from the hospital [ Time Frame: duration of the hospital stay, an expected average of approximately 3 months since birth ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Clinically significant laboratory findings [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Incidence of pneumothorax that require intubation [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Incidence of moderate to severe pulmonary hemorrhage [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Incidence of intraventricular hemorrhage of grade 3 or more [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bronchopulmonary Dysplasia
  • Biological: Pneumostem®
    Other Name: Human umbilical cord blood-derived mesenchymal stem cells
  • Other: Normal Saline
    Other Name: Normal Saline
  • Experimental: Pneumostem®
    A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
    Intervention: Biological: Pneumostem®
  • Placebo Comparator: normal saline
    A single intratracheal administration of normal saline
    Intervention: Other: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
up to 14 Days
No
Contact: Wonil Oh, MD, PhD +82-2-3465-6670 wioh@medi-post.co.kr
Korea, Republic of
 
NCT01828957
MP-CR-009
Yes
Medipost Co Ltd.
Medipost Co Ltd.
Not Provided
Principal Investigator: Won-Soon Park, MD, PhD Department of Pediatrics, Samsung Medical Center
Principal Investigator: Ai-Rhan Kim Department of Neonatology, Asan Medical Center
Medipost Co Ltd.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP