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Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
Sponsor: Medipost Co Ltd.
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
Key Details
Gender
All
Age Range
6 Months - 60 Months
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2019-07-05
Completion Date
2027-06-30
Last Updated
2025-02-07
Healthy Volunteers
No
Conditions
Interventions
PNEUMOSTEM®
A single intratracheal administration of PNEUMOSTEM® (1.0 x 10\^7 cells/kg)
normal saline
A single intratracheal administration of normal saline
Locations (2)
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea