Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Medipost Co Ltd.
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT01897987
First received: July 4, 2013
Last updated: November 18, 2013
Last verified: November 2013

July 4, 2013
November 18, 2013
December 2013
December 2016   (final data collection date for primary outcome measure)
Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection [ Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age ] [ Designated as safety issue: No ]
Readmission rate and duration of the hospital stay due to a respiratory infection [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01897987 on ClinicalTrials.gov Archive Site
  • Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator) [ Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age ] [ Designated as safety issue: No ]
  • Number of admissions to Emergency Room [ Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age ] [ Designated as safety issue: No ]
    Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems
  • Survival [ Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age ] [ Designated as safety issue: No ]
  • Growth measured by Z-score [ Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age ] [ Designated as safety issue: No ]
  • Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy [ Time Frame: 24 months, corrected age ] [ Designated as safety issue: No ]
  • Deafness or Blindness [ Time Frame: 24 months, corrected age ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: 6, 12, 24,36, 48, and 60 months, corrected age ] [ Designated as safety issue: Yes ]
  • Significant changes in vital signs [ Time Frame: 6, 12, 24, 36, 48, and 60 months, corrected age ] [ Designated as safety issue: Yes ]
  • Significant changes in physical exam [ Time Frame: 6, 12, 24, 36, 48, and 60 months, corrected age ] [ Designated as safety issue: Yes ]
  • Whether the subject is receiving oxygen treatment [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
  • Changes from Baseline in Z-score [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
  • Retinopathy of Prematurity (ROP) that require treatment with avastin or laser [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
  • Changes from baseline in BAEP and VEP tests [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
    BAEP: Brainstem Auditory Evoked Potential VEP: Visual Evoked Potential
  • Changes from Baseline in Bayley scale (PDI & MDI) [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
    PDI: Psychomotor scale MDI: Mental scale
  • Potential brain development assessment on Brain MRI [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: Yes ]
  • Number of clinically significant laboratory findings [ Time Frame: 36 months, corrected age ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT01297205 ) will be followed-up until 60 months of corrected age.

Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Bronchopulmonary Dysplasia
  • Biological: Pneumostem®
    Other Name: Human umbilical cord blood-derived mesenchymal stem cells
  • Biological: 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: Biological: normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
  • Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria:

  • Subject whose parent or legal representative does not agree to participate in the study
  • subject who is considered inappropriate to participate in the study by the investigator
Both
7 Months to 7 Months
No
Contact: Wonil Oh, MD, PhD +82-2-3465-6670 wioh@medi-post.co.kr
Korea, Republic of
 
NCT01897987
MP-CR-009-FU
Yes
Medipost Co Ltd.
Medipost Co Ltd.
Not Provided
Principal Investigator: Wonsoon Park, MD, PhD Department of Pediatrics, Samsung Medical Center
Principal Investigator: Ai-Rhan Kim, MD, PhD 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