RecruitingPhase 1Phase 2NCT02881970

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


Sponsor

Assistance Publique Hopitaux De Marseille

Enrollment

20 participants

Start Date

Feb 5, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 1 DayMax Age: 3 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called autologous cord blood stem cell for people with neonatal hypoxic ischaemic encephalopathy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGautologous 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

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NCT02881970