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
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|
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)|
|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|
Other: in vitro characterization of the cord blood stem cell
- 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.
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
|Assistance publique Hopitaux de Marseille|
|Marseille, bouches du Rhone, France, 13005|
|Principal Investigator:||Umberto SIMEONI, MD PhD||AP-HM|