Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT04003857
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Biological: PNEUMOSTEM® Biological: normal saline Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
Estimated Study Start Date : July 8, 2019
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. Deafness or Blindness [ Time Frame: 24 months corrected age ]
    Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry

  5. 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

  6. Gross Motor Function Classification System for Cerebral Palsy [ Time Frame: 24 months corrected age ]
    Gross Motor Function Classification System for Cerebral Palsy

  7. Number of adverse events [ Time Frame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth ]
    Number of adverse events

  8. 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

  9. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04003857


Contacts
Layout table for location contacts
Contact: Eunyoung LEE 82234656748 ley0113@medi-post.co.kr

Sponsors and Collaborators
Medipost Co Ltd.
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT04003857     History of Changes
Other Study ID Numbers: MP-CR-012-F/U
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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