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Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia (NEOCORD)

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ClinicalTrials.gov Identifier: NCT01284673
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.

For the moment, 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. However, before conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of neonatal asphyxia, compared to normal situation, is needed.

The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. Secondary objectives are to assess such characteristics in conditions of cryo-preservation, compared to fresh cell preparation


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Other: in vitro characterization of the cord blood stem cell Not Applicable

Detailed Description:

Methods :

Descriptive, bi-centre study on 10 cord blood samples from newborn infants with neonatal asphyxia (5) according to pre-defined criteria, compared healthy neonates (5). The total duration of the study will be 2 years. Parents will be informed and a signed parental consent will be asked in the hours following birth before the in vitro study.

Biological analysis will include elementary analyses for cell quality control, endothelial progenitor exploration, and investigation of mesenchymal stem cells function and of their neuronal differentiation potential (on fresh and frozen samples).

Statistical analysis: comparison between the 2 groups (neonatal asphyxia versus control) would use non parametric test (Mann-Whitney)

This study will allow to evaluate the therapeutic potential of cord blood stem cells autologous transplantation in neonatal asphyxia. It will contribute to the determination of the feasibility of a clinical trail of autologous, cord blood stem cells therapy in such disease.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
Study Start Date : April 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016



Intervention Details:
  • Other: in vitro characterization of the cord blood stem cell
    The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. and assessment such characteristics in conditions of cryo-preservation, compared to fresh cell preparation


Primary Outcome Measures :
  1. The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn [ Time Frame: two years ]
    The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration.



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Ages Eligible for Study:   up to 20 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • delivery at 37 week or more of pregnancy
  • normal pregnancy and delivery

Exclusion Criteria:

  • parental refusal

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): NCT01284673


Locations
France
Assistance publique Hopitaux de Marseille
Marseille, bouches du Rhone, France, 13005
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Umberto SIMEONI, MD PhD AP-HM

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01284673     History of Changes
Other Study ID Numbers: 2010-A00076-33
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Assistance Publique Hopitaux De Marseille:
Cord blood stem
neonatal asphyxia

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Asphyxia
Asphyxia Neonatorum
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Death
Pathologic Processes
Wounds and Injuries