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Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

NCT01632475 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2019-04-09

No results posted yet for this study

Summary

This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

BIOLOGICAL

Pneumostem®

A single intratracheal administration Low Dose Group (3 patients): 1.0 x 10\^7 cells/kg, High Dose Group (6 patients): 2 x 10\^7 cells/kg \* The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study.

Sponsors & Collaborators

  • Medipost Co Ltd.

    collaborator INDUSTRY

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Won-Soon Park, MD, PhD · Samsung Medical Center

Eligibility

Min Age
4 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2025-09-30
Completion
2026-09-30

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 NCT01632475 on ClinicalTrials.gov