Back to resultsNeonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells (NEOSTEM)
Primary Purpose
Neonatal Hypoxic-ischaemic Encephalopathy
Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
autologous cord blood stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Hypoxic-ischaemic Encephalopathy
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.
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neonatal hypoxic-ischaemic encephalopathy
Arm Description
Outcomes
Primary Outcome Measures
Adverse clinical or paraclinical event rates due to stem cell preparation
Secondary Outcome Measures
- Preliminary efficacy as measured by neurodevelopmental function
Full Information
NCT ID
NCT02881970
First Posted
August 24, 2016
Last Updated
August 12, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02881970
Brief Title
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Acronym
NEOSTEM
Official Title
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoxic-ischaemic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neonatal hypoxic-ischaemic encephalopathy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
autologous cord blood stem cell
Intervention Description
Injection of 5.107 / kg autologous mononuclear cells from umbilical cord blood
Primary Outcome Measure Information:
Title
Adverse clinical or paraclinical event rates due to stem cell preparation
Time Frame
2years
Secondary Outcome Measure Information:
Title
- Preliminary efficacy as measured by neurodevelopmental function
Time Frame
2years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farid BOUBRED
Email
farid.boubrd@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CATHERINE GEINDRE
Organizational Affiliation
AP HM
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FARID BOUBRED
Email
farid.boubred@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
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