Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Not Applicable
Completed
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Biological: Pneumostem®Biological: normal saline
- Registration Number
- NCT01897987
- 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 (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pneumostem® Pneumostem® A single intratracheal administration of Pneumostem® (1.0 x 10\^7 cells/kg) normal saline normal saline A single intratracheal administration of normal saline
- Primary Outcome Measures
Name Time Method Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection 6, 12, 18, 24, 36, 48, and 60 months, corrected age
- Secondary Outcome Measures
Name Time Method Number of admissions to Emergency Room 6, 12, 18, 24, 36, 48, and 60 months, corrected age Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems
Growth measured by Z-score 6, 12, 18, 24, 36, 48, and 60 months, corrected age Deafness or Blindness 24 months, corrected age Significant changes in vital signs 6, 12, 24, 36, 48, and 60 months, corrected age Significant changes in physical exam 6, 12, 24, 36, 48, and 60 months, corrected age Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator) 6, 12, 18, 24, 36, 48, and 60 months, corrected age Survival 6, 12, 18, 24, 36, 48, and 60 months, corrected age Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy 24 months, corrected age Number of adverse events 6, 12, 24,36, 48, and 60 months, corrected age
Trial Locations
- Locations (2)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of