Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

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.

Conditions

• Neonatal Encephalopathy
• Hypoxic-ischemic Encephalopathy

Interventions

OTHER

Autologous umbilical cord blood cells

Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused

Sponsors & Collaborators

• Osaka City University

  collaborator OTHER

• Yodogawa Christian Hospital

  collaborator OTHER

• Kurashiki Central Hospital

  collaborator OTHER

• Nagoya University

  collaborator OTHER

• Osaka City General Hospital

  collaborator OTHER

• Saitama Medical University

  collaborator OTHER

• National Cerebral and Cardiovascular Center, Japan

  collaborator OTHER

• National Center for Child Health and Development, Japan

  collaborator UNKNOWN

• Tokyo University

  collaborator OTHER

• Tokyo Women's Medical University

  collaborator OTHER

• Neonatal Encephalopathy Consortium, Japan

  lead NETWORK

Principal Investigators

• Haruo Shintaku, MD, PhD · Osaka City University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2017-10-31

Completion

2019-07-31

Countries

• Japan

Study Locations