NCT01649648

Autologous Cord Blood Cells for Brain Injury in Term Newborns

Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

Summary

This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).

Detailed description

The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.

Conditions

• Hypoxic Ischemic Encephalopathy

Interventions

Type	Name	Description
BIOLOGICAL	Autologous cord blood	Baby's own umbilical cord blood

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-11-01
• Completion: 2015-11-01
• First posted: 2012-07-25
• Last updated: 2017-01-26

Locations

3 sites across 1 country: Singapore