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

Phase 1

Completed

• Conditions: Immunomodulation Effect
• Interventions: Biological: autologous cord blood mononuclear cells; Biological: normal saline

• Registration Number: NCT05087498
• Lead Sponsor: Guangdong Women and Children Hospital

Brief 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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-10-09
• Study First Posted: 2021-10-21
• Study Start: 2021-11-28
• Primary Completion: 2022-08-18
• Study Completion: 2022-08-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-24
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACBMNC infusion group	autologous cord blood mononuclear cells	Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion within 24 h after process. Cell dose for all patients was 2-10×107 cells per kilogram.
control group	normal saline	Those in control group will receive an infusion of a placebo solution which is normal saline with the same volume per kg.

Primary Outcome Measures

Name	Time	Method
immunomodulation effect	during 7 days after intervention	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
success rate of cord blood collection	during 6 months after intervention	cord blood collection, cell available, infused cell number
complications	during 6 months after intervention	frequency of complications such IVH, NEC, retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), LOS, and persistent pulmonary hypertension of newborn (PPHN) and anemia.

Trial Locations

Locations (1)

Jie Yang; 🇨🇳 Guangzhou, Guangdong, China