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

Medipost Co Ltd.62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bronchopulmonary Dysplasia

Interventions

Pneumostem®BIOLOGICAL

normal salineBIOLOGICAL

Eligibility

Sex: ALLMin age: 7 MonthsMax age: 7 Months

Medical Language ↔ Plain English

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

Locations (2)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection