Assistance Publique Hopitaux de Marseille
Marseille, France
Location status: Recruiting
Recruiting
NCT Number: NCT02881970
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
1 day–3 day
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 prolapse, uterine rupture, maternal hemorrhage)
- and a 5 minutes Apgar score ≤ 5, or a continued need for resuscitation, including endotracheal or mask ventilation at 5 min after birth.
- signs of encephalopathy within 12 hours of age (Sarnat and Sarnat classification, score ≥ 2)
- ± abnormal electroencephalogram or aEEG within 12 hours of age
- therapeutic hypothermia.
- no maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus.
- maternal negative serology for syphilis
- written parental consent
Exclusion criteria
- presence of known chromosomal anomaly.
- presence of major congenital anomalies. severe intrauterine growth restriction (weight <1800g)
- infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
Treatment and study plan
autologous cord blood stem cell
DrugInjection of 5.107 / kg autologous mononuclear cells from umbilical cord blood
Primary outcomes
-
Adverse clinical or paraclinical event rates due to stem cell preparation
Time frame: 2years
Secondary outcomes
-
- Preliminary efficacy as measured by neurodevelopmental function
Time frame: 2years
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assistance Publique Hopitaux De Marseille
Other
Registry information
Acronym: NEOSTEM
Important dates
- Study start
- 2020
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Aug 29, 2016
- Registry last updated
- Aug 5, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.