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NCT05087498

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

Completed Phase 1 Last updated 2 January 2024
What this trial tests

Phase 1 trial testing autologous cord blood mononuclear cells in Immunomodulation Effect in 8 participants. Completed in 18 August 2022.

Timeline
28 November 2021
Primary endpoint
18 August 2022
18 August 2022

Quick facts

Lead sponsorGuangdong Women and Children Hospital
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment8
Start date28 November 2021
Primary completion18 August 2022
Estimated completion18 August 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Guangdong Women and Children Hospital

Who can join

Adults 24 Weeks to 32 Weeks, any sex, with Immunomodulation Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial.
    Zhuxiao R, Ruoyu H, Liling Y, Xuejun R, et al · · 2022 · PMID 36568414 · DOI 10.3389/fped.2022.884366

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Other trials of autologous cord blood mononuclear cells

Trials testing the same drug.

Other Guangdong Women and Children Hospital trials

Trials by the same sponsor.

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