Status:
TERMINATED
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
Lead Sponsor:
United Therapeutics
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
3-14 years
Phase:
PHASE1
Brief Summary
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at \<27 weeks of gestational age (GA) at high risk for bronchopulmonary dyspla...
Detailed Description
The study was discontinued by the Sponsor on 24 February 2021 due to a business decision, not related to reasons of safety or efficacy. Only data listings were created; no summary or inferential analy...
Eligibility Criteria
Inclusion
- Infant whose postnatal age was 3 to 14 days
- Subjects met the following oxygen and birth weight criteria based on gestational age: 23 weeks to 24 weeks 6 days (any birth weight, any oxygen requirement) or 25 weeks to 26 weeks 6 days (fraction of inspired oxygen \[FiO2\] ≥35% \[sustained for \>2 hours\] at any point during postnatal Days 1 to 14 AND birth weight ≤750 g)
- Endotracheally intubated and receiving mechanical ventilation at the time of Screening and randomization.
- Not expected to be extubated within the next 24 hours after randomization.
- The subject had a parent/guardian who gave written informed consent.
Exclusion
- Had a congenital heart defect, except for PDA, atrial septal defect or a small/moderate, restrictive ventricular septal defect.
- Had a serious malformation of the lung, such as pulmonary hypoplasia/aplasia, congenital diaphragmatic hernia, or any other congenital lung anomaly.
- Was being treated with inhaled nitric oxide.
- Had a known chromosomal abnormality (eg, Trisomy 18, Trisomy 13, or Trisomy 21) or a severe congenital malformation (eg, hydrocephalus and encephalocele, trachea-esophageal fistula, abdominal wall defects, and major renal anomalies).
- Had a known severe congenital infectious disease (ie, herpes, toxoplasmosis rubella, syphilis, human immunodeficiency virus, cytomegalovirus, etc).
- High clinical suspicion of active systemic infection, severe sepsis, or septic shock during Screening.
- Underwent a surgical procedure (requiring admission to an operating room) within 72 hours before randomization or who was anticipated to have a surgical procedure (requiring admission to an operating room) within 72 hours before or following randomization.
- Had a Grade 3 or 4 intracranial hemorrhage.
- Had active pulmonary hemorrhage.
- The subject was currently participating in any other interventional clinical study.
- The subject was, in the opinion of the Investigator, so ill that death was inevitable, or was considered inappropriate for the study for any reason(s) other than those listed above.
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03857841
Start Date
October 9 2019
End Date
May 20 2021
Last Update
October 12 2021
Active Locations (6)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215