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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2027-06-30

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 (NCT03392467) 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: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.

Conditions

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Bronchopulmonary Dysplasia BPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PNEUMOSTEM®

A single intratracheal administration of Pneumostem® (10.0 x 10\^6 cells/kg)

Group Type EXPERIMENTAL

PNEUMOSTEM®

Intervention Type BIOLOGICAL

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

normal saline

A single intratracheal administration of normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type BIOLOGICAL

A single intratracheal administration of normal saline

Interventions

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PNEUMOSTEM®

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

Intervention Type BIOLOGICAL

normal saline

A single intratracheal administration of 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 enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
* 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

6 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No