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RECRUITING
NCT02881970
PHASE1/PHASE2

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

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

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

DRUG

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