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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Medipost Co Ltd.
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT01897987
First received: July 4, 2013
Last updated: April 18, 2017
Last verified: April 2017
July 4, 2013
April 18, 2017
January 2014
April 2020   (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 ]
Readmission rate and duration of the hospital stay due to a respiratory infection [ Time Frame: 36 months, corrected age ]
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 ]
  • Number of admissions to Emergency Room [ Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age ]
    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 ]
  • Growth measured by Z-score [ Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age ]
  • Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy [ Time Frame: 24 months, corrected age ]
  • Deafness or Blindness [ Time Frame: 24 months, corrected age ]
  • Number of adverse events [ Time Frame: 6, 12, 24,36, 48, and 60 months, corrected age ]
  • Significant changes in vital signs [ Time Frame: 6, 12, 24, 36, 48, and 60 months, corrected age ]
  • Significant changes in physical exam [ Time Frame: 6, 12, 24, 36, 48, and 60 months, corrected age ]
  • Whether the subject is receiving oxygen treatment [ Time Frame: 36 months, corrected age ]
  • Survival rate [ Time Frame: 36 months, corrected age ]
  • Changes from Baseline in Z-score [ Time Frame: 36 months, corrected age ]
  • Retinopathy of Prematurity (ROP) that require treatment with avastin or laser [ Time Frame: 36 months, corrected age ]
  • Changes from baseline in BAEP and VEP tests [ Time Frame: 36 months, corrected age ]
    BAEP: Brainstem Auditory Evoked Potential VEP: Visual Evoked Potential
  • Changes from Baseline in Bayley scale (PDI & MDI) [ Time Frame: 36 months, corrected age ]
    PDI: Psychomotor scale MDI: Mental scale
  • Potential brain development assessment on Brain MRI [ Time Frame: 36 months, corrected age ]
  • Number of adverse events [ Time Frame: 36 months, corrected age ]
  • Number of clinically significant laboratory findings [ Time Frame: 36 months, corrected age ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Bronchopulmonary Dysplasia
  • Biological: Pneumostem®
    Other Name: Human umbilical cord blood-derived mesenchymal stem cells
  • Biological: 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.
 
Recruiting
70
April 2020
April 2020   (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
Sexes Eligible for Study: All
7 Months to 7 Months   (Child)
No
Contact: Wonil Oh, MD, PhD +82-2-3465-6670 wioh@medi-post.co.kr
Korea, Republic of
 
 
NCT01897987
MP-CR-009-FU
Yes
Not Provided
Not Provided
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.
April 2017

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