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Autologous Stem Cells in Newborns With Oxygen Deprivation

NCT01506258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-01-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.

Conditions

  • Apgar; 0-3 at 1 Minute
  • Metabolic Acidosis
  • Hypoxia, Brain
  • Multiple Organ Failure

Interventions

PROCEDURE

Application of Stem Cells

IV infusion of autologous stem cells within the first 48 hours after birth.

PROCEDURE

Observation

Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Consuelo Mancias-Guerra, MD · Hospital Universitario Dr. Jose E. Gonzalez

  • Alma R Marroquin-Escamilla, MD · Hospital Universitario Dr. Jose E. Gonzalez

  • David Gómez-Almaguer, MD · Hospital Universitario Dr. Jose E. Gonzalez

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
37 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • Mexico

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 NCT01506258 on ClinicalTrials.gov