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

Phase 2Active Not RecruitingNCT04003857

Medipost Co Ltd.60 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 (NCT03392467) 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: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bronchopulmonary Dysplasia BPD

Interventions

PNEUMOSTEM®BIOLOGICAL

A single intratracheal administration of PNEUMOSTEM® (1.0 x 10\^7 cells/kg)

normal salineBIOLOGICAL

A single intratracheal administration of normal saline

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 60 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product * 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