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

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ClinicalTrials.gov Identifier: NCT02881970
Recruitment Status : Not yet recruiting
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Neonatal Hypoxic-ischaemic Encephalopathy Drug: autologous cord blood stem cell Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Neonatal hypoxic-ischaemic encephalopathy Drug: autologous cord blood stem cell



Primary Outcome Measures :
  1. Adverse clinical or paraclinical event rates due to stem cell preparation [ Time Frame: 2years ]

Secondary Outcome Measures :
  1. - Preliminary efficacy as measured by neurodevelopmental function [ Time Frame: 2years ]


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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881970


Contacts
Contact: Farid BOUBRED farid.boubrd@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Not yet recruiting
Marseille, France
Contact: FARID BOUBRED       farid.boubred@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: CATHERINE GEINDRE AP HM

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02881970     History of Changes
Other Study ID Numbers: 2013-A01018-37
2013-32 ( Other Identifier: AP HM )
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ischemia
Brain Diseases
Hypoxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain