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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284673
First received: April 16, 2010
Last updated: September 2, 2014
Last verified: September 2014

April 16, 2010
September 2, 2014
April 2010
March 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration.
Same as current
Complete list of historical versions of study NCT01284673 on ClinicalTrials.gov Archive Site
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Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Respiratory Distress Syndrome
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • parental refusal
Both
up to 20 Minutes
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01284673
2009-A00076-33
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Umberto SIMEONI, MD PhD AP-HM
Assistance Publique Hopitaux De Marseille
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP