Respiratory Distress Syndrome Clinical Trial
Official title:
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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