Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial

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.

Timeline

Start

2014-01

Primary completion

2020-03

Completion

2020-03

Outcome

Missed primary endpoint

paper without statistical significance PMID 37604693 ↗

Publications

• Ahn SY, Chang YS, Lee MH, Sung S, Kim AR, Park WS. Five-year follow-up of phase II trial of stromal cells for bronchopulmonary dysplasia. Thorax. 2023 Nov;78(11):1105-1110. doi: 10.1136/thorax-2022-219622. Epub 2023 Aug 21.

Drugs

Indications