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Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study

NCT02023788 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2018-09-04

No results posted yet for this study

Summary

This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.

Conditions

  • Bronchopulmonary Dysplasia
  • Respiratory Tract Infections
  • Premature Birth of Newborn

Interventions

BIOLOGICAL

PNEUMOSTEM

A single intratracheal administration Low Dose Group (3 patients): 1.0 x 10\^7 cells/kg High Dose Group (6 patients): 2.0 x 10\^7 cells/kg \* The subjects were administered with Pneumostem in the earlier part of the Phase I study. No drug/biologics will be administered to any subject during this part of the study.

Sponsors & Collaborators

  • Medipost Co Ltd.

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
45 Months
Max Age
63 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

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 NCT02023788 on ClinicalTrials.gov