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

NCT01284673 | Completed

• 1 other identifier: 2010-A00076-33
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Distress Syndrome

Keywords

Cord blood stem; neonatal asphyxia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

in vitro characterization of the cord blood stem cell OTHER

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

Eligibility Criteria

• Age: 1 Minute - 20 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• parental refusal

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance publique Hopitaux de Marseille

Marseille, bouches du Rhone, 13005, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Umberto SIMEONI, MD PhD

  AP-HM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: January 27, 2011
• Study Start: April 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

FR (1)