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Clinical Trials in France / NCT02881970
Recruiting Phase 1/2

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

NCT02881970 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique Hopitaux De Marseille
Phase
Phase 1/2
Started
2020-02-05
Last updated
2024-08-05

Condition(s) studied

Neonatal Hypoxic-ischaemic Encephalopathy

Investigational drug(s) / intervention(s)

autologous cord blood stem cell

autologous cord blood stem cell: Injection of 5.107 / kg autologous mononuclear cells from umbilical cord blood

Study 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

Sex
ALL
Min age
1 Day
Max age
3 Days
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Adverse clinical or paraclinical event rates due to stem cell preparation — 2years

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Hopitaux de Marseille Marseille France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02881970 on ClinicalTrials.gov ↗ ← All trials in France