Autologous Cord Blood Cells for Brain Injury in Term Newborns

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoxic Ischemic Encephalopathy

Intervention / Treatment
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* Biological: Autologous cord blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Autologous umbilical cord blood available >36 weeks gestation Brain injury that satisfies criteria for therapeutic hypothermia Parental informed consent Exclusion Criteria: Inability to enroll by 3 postnatal days of age. Presence of known chromosomal anomaly. Presence of major congenital anomalies. Severe intrauterine growth restriction Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist. Parents refuse consent. Attending neonatologist refuses consent. Failure to collect the infant's cord blood and/or laboratory unable to process cord blood

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Autologous cord blood cells arm | Biological: Autologous cord blood<br>* Baby's own umbilical cord blood<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopment | Peabody tests, Bayley Scales of Infant Development | 1 month-2 years old | 
| Brain imaging | MRI brain at 1-2 weeks old and 4-6 months old | 1 week-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxic ischemic encephalopathy, Autologous cord blood