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Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy | Clinical Trials | Clareo Health

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Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

A Pilot Feasibility and Safety Study of Autologous Umbilical Cord Blood Cell Therapy in Infants With Neonatal Encephalopathy

NCT02256618•Neonatal Encephalopathy Consortium, Japan

View on ClinicalTrials.gov

Summary

This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.

Detailed Description

This is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. Infants will be followed for safety and neurodevelopmental outcome up to 18 months.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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. Autologous umbilical cord blood available to infuse within 3 days after birth
•7. 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. Hyperkalemia
•6. Outborn infants (Infants born at hospitals other than the study sites)
•7. Volume of collected cord blood \<40 ml
•8. Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

Locations (6)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Saitama Medical University

Kawagoe, Saitama, Japan

Yodogawa Christian Hospital

Osaka, Japan

Osaka City General Hospital

Osaka, Japan

Osaka City University

Osaka, Japan

Key Dates

Start Date

August 1, 2014

Primary Completion Date

October 1, 2017

Completion Date

July 1, 2019

Last Updated

October 29, 2019

Enrollment

ACTUAL participants

Conditions

Neonatal EncephalopathyHypoxic-ischemic Encephalopathy

Interventions

Autologous umbilical cord blood cells

OTHER

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Hypoxic-Ischemic Encephalopathy

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RECRUITING

Neonatal Neurologic Intensive Care Network of China

NCT02544100

Neonatal EncephalopathySuspected Neonatal Encephalopathy

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RECRUITING

Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

Inclusion Criteria

Exclusion Criteria

Dose Optimization of Caffeine for HIE

Neonatal Neurologic Intensive Care Network of China

Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

Predicting Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest