Immunomodulation Effect Clinical Trial
Official title:
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU: a Randomized Controlled Trial -The Premature Autologous Cord-blood Immunomodulatory Study (PAIRS)
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
This was a randomized, placebo-controlled, double-blinded trial involving eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair. 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 ACB-MNCs infusion, along with paired controls. Feasibility, safety and clinical outcomes improvement of the ACB-MNCs infusion in both short and long term were also assessed. ;