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Completed

NCT Number: NCT02381366

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

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

3 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells

Biological

Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells:

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

Other names: PNEUMOSTEM®

Primary outcomes

  1. Number of participants with adverse reactions for 84 days after treatment

    Time frame: 84 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medipost, Inc.

Industry

Collaborators

  • Medipost Co Ltd.

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Mar 6, 2015
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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