Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-03-31

Brief Summary

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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 (NCT01828957) will be followed-up until 60 months of corrected age.

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Detailed Description

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Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Pneumostem®

A single intratracheal administration of Pneumostem® (1.0 x 10\^7 cells/kg)

Group Type EXPERIMENTAL

Pneumostem®

Intervention Type BIOLOGICAL

normal saline

A single intratracheal administration of normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type BIOLOGICAL

Interventions

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Pneumostem®

Intervention Type BIOLOGICAL

normal saline

Intervention Type BIOLOGICAL

Other Intervention Names

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Human umbilical cord blood-derived mesenchymal stem cells

Eligibility Criteria

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Inclusion Criteria

* Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
* Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria

* Subject whose parent or legal representative does not agree to participate in the study
* subject who is considered inappropriate to participate in the study by the investigator

Minimum Eligible Age

7 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No