The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells

Study Overview
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Brief Summary
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To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury

Detailed Description
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The purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in 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 stem cells for the Gunagdong Cord Blood Bank,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 stem cells if an adequate number of cells that meet Guangdong 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. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.

Official Title
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The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells

Conditions
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Safety Issues, Effect of Drugs

Intervention / Treatment
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* Other: autologous umbilical cord blood stem cells
* Drug: 0.9% Sodium-chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers must have consented for cord blood collection at delivery cord blood must be available for extraction of stem cells. ->28 weeks gestation,<37weeks 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: 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.

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride | Drug: 0.9% Sodium-chloride<br>* 0.9% Sodium-chloride in control group<br>|
| Experimental: infusion<br>preterm infants with severe hypoxic ischemic encephalopathy will receive up to 4 infusions of their own volume reduced cord blood stem cells. The number of doses will be determined by the amount of available cord blood stem cells. The dose for each infusion is 5x107 cells/kg | Other: autologous umbilical cord blood stem cells<br>* autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants | Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group | during infusion 24 hours after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants | the effect of autologous umbilical cord blood stem cells infusion will be measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, brain injury