Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

• Conditions: Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
• Interventions: Biological: Autologous cord blood cell therapy

• Registration Number: NCT02455830
• Lead Sponsor: Neonatal Encephalopathy Consortium, Japan

Brief Summary

This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.

Detailed Description

The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-29
• Primary Completion: 2020-03
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Infants are eligible if they meet all the following inclusion criteria except 4.

1. ≥36 weeks gestation
2. Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH <7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
3. Moderate to severe encephalopathy (Sarnat II to III)
4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
5. Up to 24 hours of age
6. A person with parental authority must have consented for the study.

Exclusion Criteria

1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases
2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
3. Severe growth restriction, with birth-weight less than 1800 g
4. Severe infectious disease, such as sepsis
5. Infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia by the attending neonatologist

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cell-treated	Autologous cord blood cell therapy	Infants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia.

Primary Outcome Measures

Name	Time	Method
Changes in serum levels of cytokines and trophic factors	From birth up to 10 days of age

Secondary Outcome Measures

Name	Time	Method
Association with neuroimaging and neurodevelopmental functional outcome	18 months	Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be assessed whether they are associated with serum levels of cytokines and trophic factors during the early neonatal period.

Trial Locations

Locations (6)

Yodogawa Christian Hospital; 🇯🇵 Osaka, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Okayama, Japan

Saitama Medical Center; 🇯🇵 Kawagoe, Saitama, Japan

Osaka City General Hospital; 🇯🇵 Osaka, Japan

Osaka City University Hospital; 🇯🇵 Osaka, Japan