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

February 4, 2025 updated by: Medipost Co Ltd.
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PNEUMOSTEM®
A single intratracheal administration of Pneumostem® (10.0 x 10^6 cells/kg)
Biological: PNEUMOSTEM®
A single intratracheal administration of PNEUMOSTEM® (1.0 x 10^7 cells/kg)
Other Names:
  • Human umbilical cord blood-derived mesenchymal stem cells
Placebo Comparator: normal saline
A single intratracheal administration of normal saline
Biological: normal saline
A single intratracheal administration of normal saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiratory outcome: Number of hospitalizations
Time Frame: 6 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection
6 months corrected age
Respiratory outcome: Number of hospitalizations
Time Frame: 12 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection
12 months corrected age
Respiratory outcome: Number of hospitalizations
Time Frame: 18 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group
18 months corrected age
Respiratory outcome: Number of hospitalizations
Time Frame: 24 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection
24 months corrected age
Respiratory outcome: Number of hospitalizations
Time Frame: 36 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
36 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 39 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
39 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 42 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
42 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 45 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
45 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 48 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
48 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 51 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
51 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 54 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
54 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 57 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
57 months after birth
Respiratory outcome: Number of hospitalizations
Time Frame: 60 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
60 months after birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
check whether patient is alive or dead at evaluation time point
6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Growth measured by Z-score
Time Frame: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Growth measured by Z-score
6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)
Time Frame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST)
6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Deafness or Blindness
Time Frame: 24 months corrected age
Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry
24 months corrected age
Bayley Scales of Infant and Toddler Development (Third Edition)
Time Frame: 18~24months corrected age, 36~42months after birth
Scale: cognitive, motor, language, social-emotional, adaptive behavior
18~24months corrected age, 36~42months after birth
Gross Motor Function Classification System for Cerebral Palsy
Time Frame: 24 months corrected age
Gross Motor Function Classification System for Cerebral Palsy
24 months corrected age
Number of adverse events
Time Frame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Number of adverse events
6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Number of admissions to Emergency Room (ER)
Time Frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point
6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Medical treatment records
Time Frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point
6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipost Co Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wonsoon Park, MD, PhD, Department of Pediatrics, Samsung Medical Center
  • Principal Investigator: Ai-Rhan Kim, MD, PhD, Department of Neonatology, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-CR-012-F/U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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