NCT02256618

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Neonatal Encephalopathy Consortium, Japan · Network
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Encephalopathy
• Hypoxic-ischemic Encephalopathy

Interventions

Type	Name	Description
OTHER	Autologous umbilical cord blood cells	Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-10-01
• Completion: 2019-07-01
• First posted: 2014-10-03
• Last updated: 2019-10-29

Locations

6 sites across 1 country: Japan