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Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU

NCT05087498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-01-02

No results posted yet for this study

Summary

Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with intravenous ACBMNC infusion in very preterm monozygotic twins

Conditions

  • Immunomodulation Effect

Interventions

BIOLOGICAL

autologous cord blood mononuclear cells

preterm neonates less than 32 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (2-10×107cells/kg) within 24 hours after birth

BIOLOGICAL

normal saline

preterm neonates less than 32 weeks are assigned to receive normal saline within 24 hours after birth

Sponsors & Collaborators

  • Guangdong Women and Children Hospital

    lead OTHER

Principal Investigators

  • Jie Yang · Guangdong Women and Children Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-28
Primary Completion
2022-08-18
Completion
2022-08-18

Countries

  • China

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 NCT05087498 on ClinicalTrials.gov