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
  Purpose

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Biological: Pneumostem®
Other: Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: April 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumostem®
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
Biological: Pneumostem®
Other Name: Human umbilical cord blood-derived mesenchymal stem cells
Placebo Comparator: normal saline
A single intratracheal administration of normal saline
Other: Normal Saline
Other Name: Normal Saline

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828957

Contacts
Contact: Wonil Oh, MD, PhD +82-2-3465-6670 wioh@medi-post.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Won-Soon Park, MD, PhD         
Sub-Investigator: Yoon-Sil Jang, MD, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Ai-Rhan Kim, MD, PhD         
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
Principal Investigator: Won-Soon Park, MD, PhD Department of Pediatrics, Samsung Medical Center
Principal Investigator: Ai-Rhan Kim Department of Neonatology, Asan Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT01828957     History of Changes
Other Study ID Numbers: MP-CR-009
Study First Received: April 2, 2013
Last Updated: November 1, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Medipost Co Ltd.:
Human Umbilical Cord Blood Derived Mesenchymal Stem Cells
Bronchopulmonary dysplasia
Premature infants

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 30, 2014