Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

Last updated: October 28, 2019
Sponsor: Neonatal Encephalopathy Consortium, Japan
Overall Status: Completed

Phase

1

Condition

Neurologic Disorders

Stroke

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT02256618
UMIN000014903
  • Ages < 24
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 10minutes, or severe acidosis, defined as pH <7.0 or base deficit ≥16 mmol/L in a sampleof 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

Exclusion Criteria:

  1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases

  2. Major intracranial hemorrhage identified by brain ultrasonography or computedtomography

  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 bythe attending neonatologist

Study Design

Total Participants: 6
Study Start date:
August 01, 2014
Estimated Completion Date:
July 31, 2019

Study 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.

Connect with a study center

  • Nagoya University Hospital

    Nagoya, Aichi 466-8560
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashiki, Okayama 710-8602
    Japan

    Site Not Available

  • Saitama Medical University

    Kawagoe, Saitama 350-0495
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Site Not Available

  • Osaka City University

    Osaka, 545-8585
    Japan

    Site Not Available

  • Yodogawa Christian Hospital

    Osaka, 533-0032
    Japan

    Site Not Available

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