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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-32 | Other Identifier | AP HM |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonatal hypoxic-ischaemic encephalopathy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous cord blood stem cell | Drug | Injection of 5.107 / kg autologous mononuclear cells from umbilical cord blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse clinical or paraclinical event rates due to stem cell preparation | 2years |
| Measure | Description | Time Frame |
|---|---|---|
| - Preliminary efficacy as measured by neurodevelopmental function | 2years |
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Inclusion Criteria:
Term ≥ 36 weeks of gestation
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farid BOUBRED | Contact | farid.boubrd@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| CATHERINE GEINDRE | AP HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Recruiting | Marseille | France |
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