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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01649648

Enrollment

Registered

2012-07-25

Start date

2011-09-30

Completion date

2015-11-30

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic ischemic encephalopathy, Autologous cord blood

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.

Interventions

BIOLOGICALAutologous cord blood

Baby's own umbilical cord blood

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 3 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	1-3 days of age	Adverse event rates occurring in the recipients

Secondary

Measure	Time frame	Description
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026