Autologous Cord Blood Cells for Brain Injury in Term Newborns

Phase 1

Completed

• Conditions: Hypoxic Ischemic Encephalopathy
• Interventions: Biological: Autologous cord blood

• Registration Number: NCT01649648
• Lead Sponsor: National University Hospital, Singapore

Brief 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.

Study Timeline

• Study Start: 2011-09
• Status Verified: 2012-04
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-25
• Primary Completion: 2013-11
• Study Completion: 2015-11
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Autologous umbilical cord blood available
2. >36 weeks gestation
3. Brain injury that satisfies criteria for therapeutic hypothermia
4. Parental informed consent

Exclusion Criteria

1. Inability to enroll by 3 postnatal days of age.
2. Presence of known chromosomal anomaly.
3. Presence of major congenital anomalies.
4. Severe intrauterine growth restriction
5. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
6. Parents refuse consent.
7. Attending neonatologist refuses consent.
8. Failure to collect the infant's cord blood and/or laboratory unable to process cord blood

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Autologous cord blood	Autologous cord blood cells arm

Primary Outcome Measures

Name	Time	Method
Safety	1-3 days of age	Adverse event rates occurring in the recipients

Secondary Outcome Measures

Name	Time	Method
Neurodevelopment	1 month-2 years old	Peabody tests, Bayley Scales of Infant Development
Brain imaging	1 week-6 months	MRI brain at 1-2 weeks old and 4-6 months old

Trial Locations

Locations (3)

National University Hospital; 🇸🇬 Singapore, Singapore

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore