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NCT01284673 Clinical Trial

Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

Respiratory Distress Syndrome Clinical Trial

— NEOCORD  

Official title:
Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01284673
Other study ID # 2010-A00076-33
Secondary ID
Status Completed
Phase N/A
First received April 16, 2010
Last updated August 2, 2016
Start date April 2010
Est. completion date March 2016

Study information
Verified date August 2016
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 20 Minutes
Eligibility Inclusion Criteria:

- delivery at 37 week or more of pregnancy

- normal pregnancy and delivery

Exclusion Criteria:

- parental refusal

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Assistance publique Hopitaux de Marseille Marseille bouches du Rhone

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. two years No
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