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Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study

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ClinicalTrials.gov Identifier: NCT02381366
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Medipost Co Ltd.
Information provided by (Responsible Party):
Medipost America Inc.

Brief Summary:
PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of PNEUMOSTEM® in premature infants at high risk for BPD.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I/II, Open-Label Dose Escalation Trial to Evaluate the Safety and Efficacy of Two Dose Levels of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD)
Actual Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PNEUMOSTEM®
Dose A: PNEUMOSTEM® 10 million cells per kg Dose B: PNEUMOSTEM® 20 million cells per kg
Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells

Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells:

Dose A: 10 million cells per kg / Dose B: 20 million cells per kg

Other Name: PNEUMOSTEM®




Primary Outcome Measures :
  1. Number of participants with adverse reactions for 84 days after treatment [ Time Frame: 84 days ]

Secondary Outcome Measures :
  1. Number of participants with adverse reactions between 84 days after treatment and 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]
  2. Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA) [ Time Frame: 36 weeks PMA ]
  3. Hospital Re-admission between 84 days after treatment until 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]
  4. Bayley Scales of Infant and Toddler Development between 84 days after treatment until 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]


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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
  • A subject whose gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks)
  • A subject whose birth weight is between 500g and 1000g, inclusive
  • A subject who is intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
  • A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment
  • A subject whose parent/guardian can give a written informed consent

Exclusion Criteria:

  • A subject who has a congenital heart defect, except for patent ductus arteriosus (PDA), atrial septal defect (ASD) or a small, restrictive ventricular septal defect (VSD)
  • A subject who has a serious malformation of the lung such as pulmonary hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly
  • A subject who has a chromosomal abnormality (e.g., Trisomy 18, Trisomy 13 or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies)
  • A subject who has had a severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, HIV, etc.)
  • A subject who has evidence of severe sepsis or septic shock due to an active infection at Screening
  • A subject who underwent a surgical procedure within 72 hours before study drug administration or who is anticipated to have a surgical procedure within 72 hours before or following study drug administration
  • A subject who was administered surfactant within 24 hours before study drug administration
  • A subject who has had a bilateral grade 3 or 4 intracranial hemorrhage
  • A subject who has active pulmonary hemorrhage or an active air leak syndrome at Screening
  • A subject who is currently participating in any other interventional clinical trial
  • A subject who is, in the opinion of the Principal Investigator, considered inappropriate for the trial due to any reasons other than those listed above

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): NCT02381366


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Medipost America Inc.
Medipost Co Ltd.
Investigators
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Principal Investigator: Steven Powell, MD Rush University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medipost America Inc.
ClinicalTrials.gov Identifier: NCT02381366     History of Changes
Other Study ID Numbers: MD-BPD-US001
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Medipost America Inc.:
Mesenchymal Stem Cells
Human Umbilical Cord Blood
Premature Infants
Bronchopulmonary Dysplasia
Chronic Lung Disease
Cell Therapy

Additional relevant MeSH terms:
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Premature Birth
Hyperplasia
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases