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Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Sponsor: Samsung Medical Center
Summary
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
Official title: Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Key Details
Gender
All
Age Range
4 Months - 2 Years
Study Type
OBSERVATIONAL
Enrollment
9
Start Date
2011-09
Completion Date
2026-09
Last Updated
2019-04-09
Healthy Volunteers
No
Conditions
Interventions
Pneumostem®
A single intratracheal administration Low Dose Group (3 patients): 1.0 x 10\^7 cells/kg, High Dose Group (6 patients): 2 x 10\^7 cells/kg \* The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study.
Locations (2)
Samsung Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea