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

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
in vitro characterization of the cord blood stem cell
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Distress Syndrome focused on measuring Cord blood stem, neonatal asphyxia

Eligibility Criteria

1 Minute - 20 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • parental refusal

Sites / Locations

  • Assistance publique Hopitaux de Marseille

Outcomes

Primary Outcome Measures

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 Outcome Measures

Full Information

First Posted
April 16, 2010
Last Updated
August 2, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01284673
Brief Title
Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
Acronym
NEOCORD
Official Title
Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Cord blood stem, neonatal asphyxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
in vitro characterization of the cord blood stem cell
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
20 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: delivery at 37 week or more of pregnancy normal pregnancy and delivery Exclusion Criteria: parental refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto SIMEONI, MD PhD
Organizational Affiliation
AP-HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance publique Hopitaux de Marseille
City
Marseille
State/Province
bouches du Rhone
ZIP/Postal Code
13005
Country
France

12. IPD Sharing Statement

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

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