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

Phase 1

Recruiting

• Conditions: Neonatal Hypoxic-ischaemic Encephalopathy
• Interventions: Drug: autologous cord blood stem cell

• Registration Number: NCT02881970
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-29
• Study Start: 2020-02-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2028-04
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonatal hypoxic-ischaemic encephalopathy	autologous cord blood stem cell	-

Primary Outcome Measures

Name	Time	Method
Adverse clinical or paraclinical event rates due to stem cell preparation	2years

Secondary Outcome Measures

Name	Time	Method
- Preliminary efficacy as measured by neurodevelopmental function	2years

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France