Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

Neonatal Encephalopathy Consortium, Japan

Status: Unknown

Conditions: Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)

Treatments: Biological: Autologous cord blood cell therapy

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT02455830

UMIN000014903-Cytokines

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 2 patient groups

Cell-treated

Description:

Infants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia.

Treatment:

Biological: Autologous cord blood cell therapy

Cooled only

Description:

Infants with encephalopathy who receive therapeutic hypothermia only.