Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells

Study Overview
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Brief Summary
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Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss. Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions. Cord blood stem cells are a promising treatment for the near future. The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy. The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration

Official Title
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Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells

Conditions
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Neonatal Hypoxic-ischaemic Encephalopathy

Intervention / Treatment
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* Drug: autologous cord blood stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term ≥ 36 weeks of gestation and (2) : a blood pH < 7 with base deficit > 12 mmol/l (at birth or within 60 minutes of age) or a blood pH between 7,01 and 7,15, with additionnal criteria: a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal hemorrhage) and a 5 minutes Apgar score ≤ 5, or a continued need for resuscitation, including endotracheal or mask ventilation at 5 min after birth. signs of encephalopathy within 12 hours of age (Sarnat and Sarnat classification, score ≥ 2) ± abnormal electroencephalogram or aEEG within 12 hours of age therapeutic hypothermia. no maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus. maternal negative serology for syphilis written parental consent 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.

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: Neonatal hypoxic-ischaemic encephalopathy<br> | Drug: autologous cord blood stem cell<br>* Injection of 5.107 / kg autologous mononuclear cells from umbilical cord blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse clinical or paraclinical event rates due to stem cell preparation |  | 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Preliminary efficacy as measured by neurodevelopmental function |  | 2years |