Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Infectious Disease, Neurology, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/22/2017 |
| Start Date: | January 2008 |
| End Date: | January 2017 |
Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.
This is a pilot study to test feasibility of collection, preparation and infusion of a
baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is
born with signs of brain injury.
baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is
born with signs of brain injury.
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 whose mothers have previously consented to providing cord
blood cells for the Carolinas Cord Blood Bank or other public or private bank that uses
accepted standards for collection and handling of cells, or provided verbal consent for cord
blood collection for the possibility of their baby's participation in this trial, can
receive their own cord blood cells if an adequate number of cells that meet Carolinas Cord
Blood Bank Quality standards are available in the first 14 postnatal days. Study activities
also include serial blood draws concurrent with clinically indicated blood draws with a
total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies
will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months at Duke's Special
Infant Care Clinic. MRI's will be obtained per clinical routine and results will be analyzed
and described in study reports.
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 whose mothers have previously consented to providing cord
blood cells for the Carolinas Cord Blood Bank or other public or private bank that uses
accepted standards for collection and handling of cells, or provided verbal consent for cord
blood collection for the possibility of their baby's participation in this trial, can
receive their own cord blood cells if an adequate number of cells that meet Carolinas Cord
Blood Bank Quality standards are available in the first 14 postnatal days. Study activities
also include serial blood draws concurrent with clinically indicated blood draws with a
total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies
will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months at Duke's Special
Infant Care Clinic. MRI's will be obtained per clinical routine and results will be analyzed
and described in study reports.
Inclusion Criteria:
- Mothers must have consented for cord blood collection at delivery
- cord blood must be available for extraction of stem cells.
- >34 weeks gestation
- cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or
history of acute perinatal event
- either a 10 minute Apgar < 5 or continued need for ventilation.
- All infants must have signs of encephalopathy within 6 hours of age.
Exclusion Criteria:
- Inability to enroll by 14 days of age.
- Presence of known chromosomal anomaly.
- Presence of major congenital anomalies.
- Severe intrauterine growth restriction (weight <1800g)
- 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.
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