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

NCT05087498 | Completed Phase 1 DMC

• 1 other identifier: Guangdong M CH
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Immunomodulation Effect

Keywords

autologous cord blood mononuclear cells; monozygotic twins; very premature infants

Outcome Measures

Primary Outcomes (3)

• immunomodulation effect

  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

  during 7 days after intervention

• success rate of cord blood collection

  cord blood collection, cell available, infused cell number

  during 6 months after intervention

• complications

  frequency of complications such IVH, NEC, retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), LOS, and persistent pulmonary hypertension of newborn (PPHN) and anemia.

  during 6 months after intervention

Other Outcomes (2)

• Duration of mechanical ventilation, oxygen therapy and hospitalization

  36 weeks of postmenstrual age or the discharge

• the frequence of glucocorticoid, pulmonary surfactant, blood products and re-intubation

  36 weeks of postmenstrual age or the discharge

Study Arms (2)

ACBMNC infusion group

EXPERIMENTAL

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.

Biological: autologous cord blood mononuclear cells

control group

PLACEBO COMPARATOR

Those in control group will receive an infusion of a placebo solution which is normal saline with the same volume per kg.

Biological: normal saline

Interventions

autologous cord blood mononuclear cells BIOLOGICAL

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

ACBMNC infusion group

normal saline BIOLOGICAL

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

control group

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• born at study hospitals;
• monozygotic twins (confirmed by ultrasonographic diagnosis before birth and confirm again with obstetricians during and after delivery, as monochorionic diamniotic twins and monochorionic monoamniotic Twins twins were both monozygotic twins, therefore they will be both eligible);
• gestational age (GA) \<32 weeks (GA was calculated based on the date of the last menstrual period of the mother and an ultrasonographic screening performed during the first trimester of pregnancy);
• enrolled within the first 24 postnatal hours;
• free of severe perinatal asphyxia (defined as an Apgar score of 0-3 for more than 5 minutes, a cord blood gas pH \<7.00, or both);
• free of severe congenital anomalies or genetic syndromes;
• free of maternal sepsis24,25;
• Written informed consent is obtained from the parents or guardians of the infants;
• Either of the twins has available umbilical cord blood (UCB) , and the cell number was no more than 10×107 cells per kilogram, but should not be less than 2×107 cells per kilogram.

You may not qualify if:

• (1) they exhibit severe congenital abnormalities (detected via prenatal ultrasound); (2) expected to die within the first 24 hours; (3) diagnosed with severe twin-to-twin transfusion syndrome confirmed by prenatal ultrasonography24.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Jie Yang

Guangzhou, Guangdong, 511400, China

Location

Related Publications (1)

• Zhuxiao R, Ruoyu H, Liling Y, Xuejun R, Chunhui Y, Wanfen R, Zhifeng C, Yiheng D, Qi Z, Wei W, Zhipeng L, Jingjun P, Qigai Y, Jie Y. 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. Front Pediatr. 2022 Dec 9;10:884366. doi: 10.3389/fped.2022.884366. eCollection 2022.

  PMID: 36568414 DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jie Yang

  Guangdong Women and Children Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Once the enrollment was confirmed, the research physician contacted the research nurse. They were informed with the assignment and prepared the processed cord blood MNC or normal saline. After preparation, infusion bag was covered with shading bag and infused by light-blocking infusion tube, so that the nurses who conducted the infusion and all physicians who treated the baby were not aware of the treatment assignment. We used the code name of ACBMNC number 1 or number 2 to name the infusion fluid in the computerized physician order entry. The staff who collected and analyzed the patients' data and who followed up the patients were also blinded with the assignment. The research nurse and physician that knew the allocation of treatment did not make decisions in baby's clinical care. The parents or guardians were also not aware of the assignment. Therefore, this study was double-blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: October 21, 2021
• Study Start: November 28, 2021
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: All time
• Access Criteria: all

Locations

CN (1)