Clinical trial NCT01284673: Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
Official title: Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Cord blood stem
neonatal asphyxia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* parental refusal

Primary outcomes:
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
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance publique Hopitaux de Marseille
state: bouches du Rhone
Study officials:
affiliation: AP-HM
name: Umberto SIMEONI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: