Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
- Conditions
- Bronchopulmonary DysplasiaBPD
- Interventions
- Biological: normal salineBiological: PNEUMOSTEM®
- Registration Number
- NCT04003857
- Lead Sponsor
- Medipost Co Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description normal saline normal saline A single intratracheal administration of normal saline PNEUMOSTEM® PNEUMOSTEM® A single intratracheal administration of Pneumostem® (10.0 x 10\^6 cells/kg)
- Primary Outcome Measures
Name Time Method Respiratory outcome: Number of hospitalizations 60 months after birth Total number of hospitalizations and the number of hospital stay due to respiratory infection
- Secondary Outcome Measures
Name Time Method Number of admissions to Emergency Room (ER) 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth 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
Bayley Scales of Infant and Toddler Development (Third Edition) 18~24months corrected age, 36~42months after birth Scale: cognitive, motor, language, social-emotional, adaptive behavior
Growth measured by Z-score 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth Growth measured by Z-score
Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST) 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST)
Mortality 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth check whether patient is alive or dead at evaluation time point
Deafness or Blindness 24 months corrected age Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry
Gross Motor Function Classification System for Cerebral Palsy 24 months corrected age Gross Motor Function Classification System for Cerebral Palsy
Number of adverse events 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth Number of adverse events
Medical treatment records 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth 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
Trial Locations
- Locations (2)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of