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

NCT01284673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-08-03

No results posted yet for this study

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

Conditions

  • Respiratory Distress Syndrome

Interventions

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

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Umberto SIMEONI, MD PhD · AP-HM

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Minute
Max Age
20 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284673 on ClinicalTrials.gov