Autologous Cord Blood Cells for Brain Injury in Term Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-11-30

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).

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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.

Conditions

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Hypoxic Ischemic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Autologous cord blood cells arm

Group Type EXPERIMENTAL

Autologous cord blood

Intervention Type BIOLOGICAL

Baby's own umbilical cord blood

Interventions

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Autologous cord blood

Baby's own umbilical cord blood

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No