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Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Sponsor: Assistance Publique Hopitaux De Marseille
Summary
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
Key Details
Gender
All
Age Range
1 Day - 3 Days
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2020-02-05
Completion Date
2028-09
Last Updated
2024-08-05
Healthy Volunteers
No
Interventions
autologous cord blood stem cell
Injection of 5.107 / kg autologous mononuclear cells from umbilical cord blood
Locations (1)
Assistance Publique Hopitaux de Marseille
Marseille, France