Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02256618
Study type	Interventional
Source	Neonatal Encephalopathy Consortium, Japan
Contact
Status	Completed
Phase	Phase 1
Start date	August 2014
Completion date	July 2019

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