Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants

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: NCT03392467
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.

Condition or disease Intervention/treatment Phase
Severe Bronchopulmonary Dysplasia Biological: PNEUMOSTEM Other: Placebo Phase 2

Detailed Description:
Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia in Premature Infants
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: PNEUMOSTEM
human umbilical cord blood derived mesenchymal stem cell (hUCB-MSC)
 Biological: PNEUMOSTEM
human umbilical cord blood-derived mesenchymal stem cells
Placebo Comparator: Placebo
normal saline
 Other: Placebo
normal saline


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of subjects who have severe BPD or are dead [ Time Frame: 36 weeks postmenstrual age (PMA) ]
    Percentage of subjects who have severe BPD or are dead


Secondary Outcome Measures :
  1. Percentage of subjects who have moderate/severe BPD or are dead [ Time Frame: 36 weeks PMA ]
    Percentage of subjects who have moderate/severe BPD or are dead

  2. Percentage of subjects by severity of BPD [ Time Frame: prenatal 28 days/36 weeks PMA ]
    Percentage of subjects by severity of BPD

  3. Percentage of subjects in death due to lung disease [ Time Frame: prenatal 28 days/36 weeks PMA and study end timepoint ]
    Percentage of subjects in death due to lung disease

  4. intubation duration [ Time Frame: up to 24 weeks ]
    intubation duration

  5. ventilation duration [ Time Frame: up to 24 weeks ]
    ventilation duration

  6. continuous positive airway pressure (CPAP) treatment duration [ Time Frame: up to 24 weeks ]
    continuous positive airway pressure (CPAP) treatment duration

  7. treatment duration with supplemental oxygen [ Time Frame: up to 24 weeks ]
    treatment duration with supplemental oxygen

  8. % of subjects treated with steroid for weaning ventilator [ Time Frame: up to 24 weeks ]
    % of subjects treated with steroid for weaning ventilator

  9. Retinopathy of prematurity (ROP) with stage III or higher [ Time Frame: up to 24 weeks ]
    number of subjects with ROP with stage III or higher

  10. number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy [ Time Frame: up to 24 weeks ]
    number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy

  11. z-score [ Time Frame: up to 24 weeks (visit 10) ]
    percentile for body weight, height, and head circumference

  12. days in hospitalization [ Time Frame: up to 24 weeks ]
    days in hospitalization

  13. changes in tracheal suction fluid examination [ Time Frame: from screening to 7 days after IP administration (visit 5) ]
    changes in tracheal suction fluid examination


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   up to 13 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

at screening and randomization

  1. 23 weeks to < 25 weeks of gestational age
  2. 500g to 1,250g body weight at birth
  3. premature infant within postnatal 13 days of age
  4. use ventilator with ventilation rate >12 breaths/min or oxygen supply > 25%, or use high frequency ventilator (HFV)

at IP administration

  1. premature infant within postnatal 5 to 14 days of age
  2. No improvement in ventilator setting 24 hours prior to administration of IP

Exclusion Criteria:

  1. subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure
  2. subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease
  3. subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
  4. subject with serious sepsis as active infection or shock due to sepsis
  5. subject with grade 3 or 4 of bilateral intraventricular hemorrhage
  6. at screening, subject with active pulmonary hemorrhage or active air leak syndrome
  7. subject who underwent/will undergo surgery within 72 hours before/after investigational product (IP) administration
  8. subject who is expected to be treated with surfactant within 24 hours prior to IP administration
  9. subject who is expected to be allergic to gentamicin (Birth mother's allergy for gentamicin will be confirmed).
  10. subject who have previously participated in other clinical trials
  11. subject who is considered ineligible by investigator due to other medical reasons
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03392467


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

Locations
Layout table for location information
Korea, Republic of
Asan medical Center Recruiting
Seoul, Korea, Republic of
Contact: Airhan Kim, MD         
Principal Investigator: Airhan Kim, MD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Wonsoon Park, MD         
Principal Investigator: Wonsoon Park, MD         
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Wonsoon Park Samsung Medical Center
Principal Investigator: Airhan Kim Asan Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT03392467    
Other Study ID Numbers: MP-CR-012
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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