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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284673
First received: April 16, 2010
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

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 Intervention
Respiratory Distress Syndrome
Other: in vitro characterization of the cord blood stem cell

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

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 [ Time Frame: two years ] [ Designated as safety issue: No ]
    The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration.


Estimated Enrollment: 10
Study Start Date: April 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   up to 20 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • parental refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284673

Contacts
Contact: Umberto SIMEONI, MD Phd +33491384030 umberto.simeoni@ap-hm.fr

Locations
France
Assistance publique Hopitaux de Marseille Recruiting
Marseille, bouches du Rhone, France, 13005
Contact: Umberto SIMEONI, MD Phd    +33491384030    umberto.simeoni@ap-hm.fr   
Principal Investigator: Umberto SIMEONI, MD Phd         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Umberto SIMEONI, MD PhD AP-HM
  More Information

No publications provided

Responsible Party: Jean Paul SEGADE Director, AP-HM
ClinicalTrials.gov Identifier: NCT01284673     History of Changes
Other Study ID Numbers: 2009-A00076-33
Study First Received: April 16, 2010
Last Updated: January 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
Cord blood stem
neonatal asphyxia

Additional relevant MeSH terms:
Asphyxia Neonatorum
Asphyxia
Respiratory Distress Syndrome, Newborn
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases

ClinicalTrials.gov processed this record on August 20, 2014