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 September 2014 by Medipost Co Ltd.
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT01897987
First received: July 4, 2013
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Biological: Pneumostem®
Biological: 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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial

Resource links provided by NLM:


Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 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
Biological: normal saline
Other Name: normal saline

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Months to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01897987

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: Woon-Soon Park, MD, PhD         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Ai-Rhan Kim, Md, PhD         
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT01897987     History of Changes
Other Study ID Numbers: MP-CR-009-FU
Study First Received: July 4, 2013
Last Updated: September 15, 2014
Health Authority: South Korea: Institutional Review Board

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 22, 2014