Clinical trial NCT01897987: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Keywords: Human Umbilical Cord Blood Derived Mesenchymal Stem Cells
Bronchopulmonary dysplasia
Premature infants
Lead sponsor: Medipost Co Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 62
Sex: ALL
Minimum age (years): 7
Maximum age (years): 7
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 (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.

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

Primary outcomes:
measure: Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection
timeFrame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Secondary outcomes:
measure: Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)
timeFrame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
measure: Number of admissions to Emergency Room
timeFrame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
measure: Survival
timeFrame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
measure: Growth measured by Z-score
timeFrame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
measure: Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy
timeFrame: 24 months, corrected age
measure: Deafness or Blindness
timeFrame: 24 months, corrected age
measure: Number of adverse events
timeFrame: 6, 12, 24,36, 48, and 60 months, corrected age
measure: Significant changes in vital signs
timeFrame: 6, 12, 24, 36, 48, and 60 months, corrected age
measure: Significant changes in physical exam
timeFrame: 6, 12, 24, 36, 48, and 60 months, corrected age
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: