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

August 12, 2022 updated by: Assistance Publique Hopitaux De Marseille

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neonatal hypoxic-ischaemic encephalopathy
Drug: autologous cord blood stem cell
Injection of 5.107 / kg autologous mononuclear cells from umbilical cord blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse clinical or paraclinical event rates due to stem cell preparation
Time Frame: 2years
2years

Secondary Outcome Measures

Outcome Measure
Time Frame
- Preliminary efficacy as measured by neurodevelopmental function
Time Frame: 2years
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: CATHERINE GEINDRE, AP HM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01018-37
  • 2013-32 (AP HM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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