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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

Study category: Infant Care

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Description

A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of GA at high risk for BPD

Details
Age

Child

Eligibility

Infant whose postnatal age is 3 to 14 days and meets the following criteria based on GA: o 23 weeks to 24 weeks 6 days: any birth weight, any oxygen requirement o 25 weeks to 26 weeks 6 days: fraction of inspired oxygen (FiO2) >35% AND birth weight <750 g &#8226; Endotracheally intubated and receiving mechanical ventilation &#8226; Not expected to be extubated within the next 24 hours after randomization &#8226; The subject has a parent/guardian who gives written informed consent.

Phase

I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.

Type of Study

Treatment

Locations

Childrens Hospital Colorado
University of Colorado Hospital

Principal Investigator
John Kinsella,  MD

John Kinsella, MD

Study ID

Protocol Number: 18-2881

ClinicalTrials.gov: NCT03857841

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