Clinical trial NCT04003857: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
BPD
Keywords: Human Umbilical Cord Blood Derived Mesenchymal Stem Cells
Bronchopulmonary dysplasia
Premature infants
Lead sponsor: Medipost Co Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 6 months corrected age
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 12 months corrected age
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 18 months corrected age
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 24 months corrected age
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 36 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 39 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 42 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 45 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 48 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 51 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 54 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 57 months after birth
measure: Respiratory outcome: Number of hospitalizations
timeFrame: 60 months after birth
Secondary outcomes:
measure: Mortality
timeFrame: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
measure: Growth measured by Z-score
timeFrame: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
measure: Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)
timeFrame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
measure: Deafness or Blindness
timeFrame: 24 months corrected age
measure: Bayley Scales of Infant and Toddler Development (Third Edition)
timeFrame: 18~24months corrected age, 36~42months after birth
measure: Gross Motor Function Classification System for Cerebral Palsy
timeFrame: 24 months corrected age
measure: Number of adverse events
timeFrame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
measure: Number of admissions to Emergency Room (ER)
timeFrame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
measure: Medical treatment records
timeFrame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Pediatrics, Samsung Medical Center
name: Wonsoon Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neonatology, Asan Medical Center
name: Ai-Rhan Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: