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

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

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.

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.

Inclusion Criteria:

• 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 Criteria:

• 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