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Trial record 9 of 20 for:    MSC | Bronchopulmonary Dysplasia

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

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. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE February 15, 2015
First Posted Date  ICMJE March 6, 2015
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
Number of participants with adverse reactions for 84 days after treatment [ Time Frame: 84 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Number of participants with adverse reactions for 84 days after treatment [ Time Frame: 84 days ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • 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 ]
  • Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA) [ Time Frame: 36 weeks PMA ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA) [ Time Frame: 36 weeks PMA ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE 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®
Study Arms  ICMJE Experimental: PNEUMOSTEM®
Dose A: PNEUMOSTEM® 10 million cells per kg Dose B: PNEUMOSTEM® 20 million cells per kg
Intervention: Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
Publications * Powell SB, Silvestri JM. Safety of Intratracheal Administration of Human Umbilical Cord Blood Derived Mesenchymal Stromal Cells in Extremely Low Birth Weight Preterm Infants. J Pediatr. 2019 Jul;210:209-213.e2. doi: 10.1016/j.jpeds.2019.02.029. Epub 2019 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02381366
Other Study ID Numbers  ICMJE MD-BPD-US001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medipost America Inc.
Study Sponsor  ICMJE Medipost America Inc.
Collaborators  ICMJE Medipost Co Ltd.
Investigators  ICMJE
Principal Investigator: Steven Powell, MD Rush University Medical Center
PRS Account Medipost America Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP