Status:
COMPLETED
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Lead Sponsor:
Medipost Co Ltd.
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
7-7 years
Phase:
NA
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 ...
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
- 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
- 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
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01897987
Start Date
January 1 2014
End Date
March 1 2020
Last Update
August 7 2020
Active Locations (2)
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1
Asan Medical Center
Seoul, South Korea
2
Samsung Medical Center
Seoul, South Korea