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

Recruiting now · Phase 1/Phase 2

Conditions studied: Neonatal Hypoxic-ischaemic Encephalopathy

In brief

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

Key facts

Study ID

NCT02881970

Run by

Assistance Publique Hopitaux De Marseille

People needed

20

Starts

2020-02-05

Expected to finish

2028-09-01

Last updated by the study team

2024-08-05

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Assistance Publique Hopitaux de Marseille — Marseille, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.