Actively Recruiting
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-08-05
20
Participants Needed
1
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baby born at 36 weeks of gestation or later
- Blood pH less than 7 with base deficit greater than 12 mmol/l at birth or within 60 minutes
- OR blood pH between 7.01 and 7.15 with acute perinatal event history and low 5-minute Apgar score (5 or less) or continued need for resuscitation at 5 minutes
- Signs of encephalopathy within 12 hours of age with a score of 2 or higher
- Abnormal electroencephalogram or amplitude-integrated EEG within 12 hours
- Receiving therapeutic hypothermia treatment
- No maternal infection with HIV, HTLV 1 or 2, Hepatitis B or C
- Maternal negative test for syphilis
- Written parental consent obtained
You will not qualify if you...
- Known chromosomal abnormalities
- Major congenital anomalies or severe intrauterine growth restriction (weight less than 1800g)
- Infants in critical condition where further intensive therapy will not be provided
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Assistance Publique Hopitaux de Marseille
Marseille, France
Actively Recruiting
Research Team
F
Farid BOUBRED
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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