NCT04003857

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 6 Months – 60 Months
• Healthy volunteers: Not accepted

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 (NCT03392467) will be followed-up until 60 months of corrected age

Detailed 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.

Conditions

• Bronchopulmonary Dysplasia
• BPD

Interventions

Type	Name	Description
BIOLOGICAL	PNEUMOSTEM®	A single intratracheal administration of PNEUMOSTEM® (1.0 x 10\^7 cells/kg)
BIOLOGICAL	normal saline	A single intratracheal administration of normal saline

Timeline

• Start date: 2019-07-05
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2019-07-01
• Last updated: 2025-02-07

Locations

2 sites across 1 country: South Korea