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Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia

NCT01297205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-04-07

No results posted yet for this study

Summary

PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

BIOLOGICAL

Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells

Dose A - 10 million cells per kg Dose B - 20 million cells per kg Single intratracheal administration

Sponsors & Collaborators

  • Medipost Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Won-Soon Park, M.D., PhD. · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-09-30
Completion
2011-12-31

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 NCT01297205 on ClinicalTrials.gov