Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia - Full Text View

Sponsor:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT01284673

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

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:

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

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 - French Health Products Safety Agency

Keywords provided by Assistance Publique Hopitaux De Marseille:

Cord blood stem
neonatal asphyxia

Additional relevant MeSH terms:

Asphyxia
Asphyxia Neonatorum
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
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 May 23, 2012