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

NCT02881970 Phase 1/Phase 2 RECRUITING

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

Details

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	20
Start date	2020-02-05
Completion	2028-09

Conditions

• Neonatal Hypoxic-ischaemic Encephalopathy

Interventions

• autologous cord blood stem cell

Primary outcomes

• Adverse clinical or paraclinical event rates due to stem cell preparation — 2years

Countries

France