Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Primary Purpose
Bronchopulmonary Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pneumostem®
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants
Eligibility 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
Sites / Locations
- Asan Medical Center
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pneumostem®
normal saline
Arm Description
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
A single intratracheal administration of normal saline
Outcomes
Primary Outcome Measures
Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection
Secondary Outcome Measures
Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)
Number of admissions to Emergency Room
Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems
Survival
Growth measured by Z-score
Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy
Deafness or Blindness
Number of adverse events
Significant changes in vital signs
Significant changes in physical exam
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01897987
Brief Title
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Official Title
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medipost Co Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 (NCT01828957) will be followed-up until 60 months of corrected age.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pneumostem®
Arm Type
Experimental
Arm Description
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
A single intratracheal administration of normal saline
Intervention Type
Biological
Intervention Name(s)
Pneumostem®
Other Intervention Name(s)
Human umbilical cord blood-derived mesenchymal stem cells
Intervention Type
Biological
Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Number of admissions to Emergency Room
Description
Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems
Time Frame
6, 12, 18, 24, 36, 48, and 60 months, corrected age
Title
Survival
Time Frame
6, 12, 18, 24, 36, 48, and 60 months, corrected age
Title
Growth measured by Z-score
Time Frame
6, 12, 18, 24, 36, 48, and 60 months, corrected age
Title
Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy
Time Frame
24 months, corrected age
Title
Deafness or Blindness
Time Frame
24 months, corrected age
Title
Number of adverse events
Time Frame
6, 12, 24,36, 48, and 60 months, corrected age
Title
Significant changes in vital signs
Time Frame
6, 12, 24, 36, 48, and 60 months, corrected age
Title
Significant changes in physical exam
Time Frame
6, 12, 24, 36, 48, and 60 months, corrected age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wonsoon Park, MD, PhD
Organizational Affiliation
Department of Pediatrics, Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ai-Rhan Kim, MD, PhD
Organizational Affiliation
Department of Neonatology, Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
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