The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants

ConditionsPremature Birth Extreme Prematurity Preterm Intraventricular Hemorrhage Hypoxia-Ischemia, Cerebral Neurodevelopmental Disorders

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-3

SponsorFederal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

About this trial

To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks.

Eligibility criteria

Qualifiers

None

Disqualifiers

Missing written parental consent

Damages to the nasal mucosa

Maxillofacial defects

Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period)

Trial design

Treatments tested in this trial

Exosomes derived from mesenchymal stromal cells (MSCs)

Treatment groups

10 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Lead sponsor

Source ClinicalTrials.gov