Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Recruiting
Phase 1
Phase 2
Interventional Study
Neonatal Hypoxic-ischaemic Encephalopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 3 Days
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Other
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Term ≥ 36 weeks of gestation
* and (2) :
* a blood pH \< 7 with base deficit \> 12 mmol/l (at birth or within 60 minutes of age)
* or a blood pH between 7,01 and 7,15, with additionnal criteria:
* a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prola…
Contacts