Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy) Clinical Trial

Official title:

A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02455830
• Other study ID #: UMIN000014903-Cytokines
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: Neonatal Encephalopathy Consortium, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)

Intervention

Biological:
• Autologous cord blood cell therapy
The neonates receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12-24, 36-48, and 60-72 hours after the birth.

Locations

Country	Name	City	State
Japan	Saitama Medical Center	Kawagoe	Saitama
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Osaka City General Hospital	Osaka
Japan	Osaka City University Hospital	Osaka
Japan	Yodogawa Christian Hospital	Osaka

Sponsors (11)

Lead Sponsor	Collaborator
Neonatal Encephalopathy Consortium, Japan	Kurashiki Central Hospital, Nagoya University, National Center for Child Health and Development, Japan, National Cerebral and Cardiovascular Center, Osaka City General Hospital, Osaka City University, Saitama Medical University, Tokyo University, Tokyo Women's Medical University, Yodogawa Christian Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum levels of cytokines and trophic factors		From birth up to 10 days of age
Secondary	Association with neuroimaging and neurodevelopmental functional outcome	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.	18 months