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

NCT ID: NCT02881970

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2028-09-30

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

Conditions

Neonatal Hypoxic-ischaemic Encephalopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neonatal hypoxic-ischaemic encephalopathy

Group Type: EXPERIMENTAL

autologous cord blood stem cell

Intervention Type: DRUG

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

Interventions

autologous cord blood stem cell

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CATHERINE GEINDRE

Role: STUDY_DIRECTOR

AP HM

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Farid BOUBRED

Role: CONTACT

farid.boubrd@ap-hm.fr

Facility Contacts

FARID BOUBRED

Role: primary

farid.boubred@ap-hm.fr

Other Identifiers

2013-32

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A01018-37

Identifier Type: -

Identifier Source: org_study_id