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

This study is currently recruiting participants.
Verified April 2017 by Medipost Co Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897987
First Posted: July 12, 2013
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medipost Co Ltd.
  Purpose
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 (NCT01297205 ) will be followed-up until 60 months of corrected age.

Condition Intervention Phase
Bronchopulmonary Dysplasia Biological: Pneumostem® Biological: normal saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial

Resource links provided by NLM:


Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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

  • Survival [ Time Frame: 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 ]
  • Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy [ Time Frame: 24 months, corrected age ]
  • Deafness or Blindness [ Time Frame: 24 months, corrected age ]
  • Number of adverse events [ Time Frame: 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 ]
  • Significant changes in physical exam [ Time Frame: 6, 12, 24, 36, 48, and 60 months, corrected age ]

Estimated Enrollment: 70
Study Start Date: January 2014
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumostem®
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
Biological: Pneumostem®
Other Name: Human umbilical cord blood-derived mesenchymal stem cells
Placebo Comparator: normal saline
A single intratracheal administration of normal saline
Biological: normal saline

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897987


Contacts
Contact: Wonil Oh, MD, PhD +82-2-3465-6670 wioh@medi-post.co.kr

Locations
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Ai-Rhan Kim, Md, PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Woon-Soon Park, MD, PhD         
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
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
  More Information

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT01897987     History of Changes
Other Study ID Numbers: MP-CR-009-FU
First Submitted: July 4, 2013
First Posted: July 12, 2013
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Medipost Co Ltd.:
Human Umbilical Cord Blood Derived Mesenchymal Stem Cells
Bronchopulmonary dysplasia
Premature infants

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases