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

NCT05490173 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-09-28

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

Exosomes derived from mesenchymal stromal cells (MSCs)

Exosomes derived from mesenchymal stromal cells (MSCs) will be administered intranasal in ELBW infants

Sponsors & Collaborators

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

    lead OTHER_GOV

Principal Investigators

  • Oleg Ionov, PhD, MD · NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV

  • Ekaterina Balashova, PhD, MD · NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV

  • Denis Silachev, PhD, MD · NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV

  • Anna Kirtbaya, PhD, MD · NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV

  • Victor Zubkov, PhD, MD · NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV

  • Dmitriy Degtyarev, PhD, MD · NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2026-05-22
Completion
2026-12-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490173 on ClinicalTrials.gov