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

NCT04003857 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-07

No results posted yet for this study

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

Conditions

  • Bronchopulmonary Dysplasia
  • BPD

Interventions

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

Sponsors & Collaborators

  • Medipost Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Wonsoon Park, MD, PhD · Department of Pediatrics, Samsung Medical Center

  • Ai-Rhan Kim, MD, PhD · Department of Neonatology, Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-05
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04003857 on ClinicalTrials.gov