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

August 5, 2020 updated by: Medipost Co Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

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

Ages Eligible for Study

7 months to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pneumostem®
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
Biological: Pneumostem®
Other Names:
  • Human umbilical cord blood-derived mesenchymal stem cells
PLACEBO_COMPARATOR: normal saline
A single intratracheal administration of normal saline
Biological: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection
Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
6, 12, 18, 24, 36, 48, and 60 months, corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)
Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
6, 12, 18, 24, 36, 48, and 60 months, corrected age
Number of admissions to Emergency Room
Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems
6, 12, 18, 24, 36, 48, and 60 months, corrected age
Survival
Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
6, 12, 18, 24, 36, 48, and 60 months, corrected age
Growth measured by Z-score
Time Frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
6, 12, 18, 24, 36, 48, and 60 months, corrected age
Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy
Time Frame: 24 months, corrected age
24 months, corrected age
Deafness or Blindness
Time Frame: 24 months, corrected age
24 months, corrected age
Number of adverse events
Time Frame: 6, 12, 24,36, 48, and 60 months, corrected age
6, 12, 24,36, 48, and 60 months, corrected age
Significant changes in vital signs
Time Frame: 6, 12, 24, 36, 48, and 60 months, corrected age
6, 12, 24, 36, 48, and 60 months, corrected age
Significant changes in physical exam
Time Frame: 6, 12, 24, 36, 48, and 60 months, corrected age
6, 12, 24, 36, 48, and 60 months, corrected age

Collaborators and Investigators

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

Sponsor

Medipost Co Ltd.

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)

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (ESTIMATE)

July 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-CR-009-FU

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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