Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells (NEOSTEM)
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|ClinicalTrials.gov Identifier: NCT02881970|
Recruitment Status : Not yet recruiting
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hypoxic-ischaemic Encephalopathy||Drug: autologous cord blood stem cell||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2017|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||September 2020|
|Experimental: Neonatal hypoxic-ischaemic encephalopathy||
Drug: autologous cord blood stem cell
- Adverse clinical or paraclinical event rates due to stem cell preparation [ Time Frame: 2years ]
- - Preliminary efficacy as measured by neurodevelopmental function [ Time Frame: 2years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881970
|Contact: Farid BOUBREDemail@example.com|
|Assistance Publique Hopitaux de Marseille||Not yet recruiting|
|Contact: FARID BOUBRED firstname.lastname@example.org|
|Study Director:||CATHERINE GEINDRE||AP HM|