drugset / Trial / NCT04003857

Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial

NCT04003857 ↗

Phase 2 Active not recruiting 60 enrolled Medipost Co Ltd.
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2019-07-05
Primary completion
2027-06-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PNEUMOSTEM® Cell therapy 1e+07 cells/kg Other