Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchopulmonary Dysplasia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 660 years
- Gender
- Both males and females
Description
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.
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.
Tracking Information
- NCT #
- NCT04003857
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Wonsoon Park, MD, PhD Department of Pediatrics, Samsung Medical Center Principal Investigator: Ai-Rhan Kim, MD, PhD Department of Neonatology, Asan Medical Center