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

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ClinicalTrials.gov Identifier: NCT03392467
Recruitment Status : Not yet recruiting
First Posted : January 8, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.

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 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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




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



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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

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
Contact: Eunyoung Lee 82234656748 ley0113@medi-post.co.kr

Locations
Korea, Republic of
Asan medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Airhan Kim, MD         
Principal Investigator: Airhan Kim, MD         
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Wonsoon Park, MD         
Principal Investigator: Wonsoon Park, MD         
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
Principal Investigator: Wonsoon Park Samsung Medical Center
Principal Investigator: Airhan Kim Asan Medical Center

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT03392467     History of Changes
Other Study ID Numbers: MP-CR-012
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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