Back to resultsFollow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
Primary Purpose
Bronchopulmonary Dysplasia
Status
Recruiting
Phase
Phase 2
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 enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
- 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 CenterRecruiting
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® (10.0 x 10^6 cells/kg)
A single intratracheal administration of normal saline
Outcomes
Primary Outcome Measures
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Secondary Outcome Measures
Mortality
check whether patient is alive or dead at evaluation time point
Growth measured by Z-score
Growth measured by Z-score
Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)
Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST)
Deafness or Blindness
Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry
Bayley Scales of Infant and Toddler Development (Third Edition)
Scale: cognitive, motor, language, social-emotional, adaptive behavior
Gross Motor Function Classification System for Cerebral Palsy
Gross Motor Function Classification System for Cerebral Palsy
Number of adverse events
Number of adverse events
Number of admissions to Emergency Room (ER)
Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point
Medical treatment records
whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04003857
Brief Title
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
Official Title
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medipost Co Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 (NCT03392467) 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: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.
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
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PNEUMOSTEM®
Arm Type
Experimental
Arm Description
A single intratracheal administration of Pneumostem® (10.0 x 10^6 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 Description
A single intratracheal administration of PNEUMOSTEM® (1.0 x 10^7 cells/kg)
Intervention Type
Biological
Intervention Name(s)
normal saline
Intervention Description
A single intratracheal administration of normal saline
Primary Outcome Measure Information:
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
6 months corrected age
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
12 months corrected age
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group
Time Frame
18 months corrected age
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
24 months corrected age
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
36 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
39 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
42 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
45 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
48 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
51 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
54 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
57 months after birth
Title
Respiratory outcome: Number of hospitalizations
Description
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Time Frame
60 months after birth
Secondary Outcome Measure Information:
Title
Mortality
Description
check whether patient is alive or dead at evaluation time point
Time Frame
6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Title
Growth measured by Z-score
Description
Growth measured by Z-score
Time Frame
6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Title
Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)
Description
Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST)
Time Frame
6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Title
Deafness or Blindness
Description
Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry
Time Frame
24 months corrected age
Title
Bayley Scales of Infant and Toddler Development (Third Edition)
Description
Scale: cognitive, motor, language, social-emotional, adaptive behavior
Time Frame
18~24months corrected age, 36~42months after birth
Title
Gross Motor Function Classification System for Cerebral Palsy
Description
Gross Motor Function Classification System for Cerebral Palsy
Time Frame
24 months corrected age
Title
Number of adverse events
Description
Number of adverse events
Time Frame
6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Title
Number of admissions to Emergency Room (ER)
Description
Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point
Time Frame
6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Title
Medical treatment records
Description
whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point
Time Frame
6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eunyoung LEE
Phone
82234656748
Email
ley0113@medi-post.co.kr
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
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ai-Rhan Kim, Md, PhD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woon-Soon Park, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
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