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Terminated Phase 1 Interventional Results available

A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD

ClinicalTrials.gov ID: NCT03857841

Public ClinicalTrials.gov record NCT03857841. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 7:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Safety Study of Intravenous Infusion of Bone Marrow Mesenchymal Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 dysplasia (BPD).

Study identification

NCT ID
NCT03857841
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
United Therapeutics
Industry
Enrollment
3 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
3 Days to 14 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 9, 2019 (Actual)
Primary completion
May 20, 2021 (Actual)
Completion
May 20, 2021 (Actual)
Last update posted
Oct 12, 2021

2019 – 2021

United States locations

U.S. sites
6
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
University of Colorado Hospital Aurora Colorado 80045 —
Boston Children's Hospital Boston Massachusetts 02115 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Children's Mercy Hospital Kansas City Missouri 64108 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03857841, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 12, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03857841 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →