Autologous Stem Cells in Newborns With Oxygen Deprivation

January 18, 2012 updated by: Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

When there is oxygen deprivation, more frequently in premature newborns, the brain and other organs suffer severe consequences. There is evidence that hematopoietic stem cells can help in this scenario by promoting the release of growth-enhancing factors that can help control the damage due to their "homing" capacity, which attracts them to injured sites.

Cord and placental blood have a high concentration of these stem cells, and because its obtention is relatively easy, it seems like a feasible treatment in perinatal hypoxia.

There are current clinical trials that use cryopreserved cord blood for these patients but, to do that, the stem cells have to be frozen and then thawed to be infused, losing a considerable amount of stem cells (almost half of them). We want to evaluate the same condition but infusing non-cryopreserved autologous cord and placental blood because we believe it can be more beneficial due to the greater amount of cells infused, the avoidance of the cryoprotection agent´s toxicity and the lower costs.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Recruiting
        • Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez
        • Contact:
        • Sub-Investigator:
          • Alma R Marroquin-Escamilla, MD
        • Sub-Investigator:
          • Ana Cecilia Sosa-Cortez, MD
        • Sub-Investigator:
          • Sagrario L Valdes-Burnes, MD
        • Sub-Investigator:
          • Barbara G Cardenas-del Castillo, MD
        • Sub-Investigator:
          • Adriana Nieto-Sanjuanero, MD
        • Sub-Investigator:
          • Oscar Gonzalez-Llano, MD
        • Sub-Investigator:
          • Laura Villarreal-Martinez, MD
        • Sub-Investigator:
          • Laura M Nuño-Vazquez, MD
        • Sub-Investigator:
          • Josue E Rios-Solis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Apgar < 5 at 5 minutes
  • Mixed or metabolic acidosis with a pH <7.0 from umbilical cord blood sample
  • Neurological manifestations compatible with Hypoxic-Ischemic Encephalopathy
  • Any degree of organic/systemic affectation (cardiovascular, gastrointestinal, hematologic and/or respiratory)

Exclusion Criteria:

  • Neurodegenerative, autoimmune or genetic disease
  • Active infection at birth
  • Informed Consent not signed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Patients not infused with stem cells
Historic Controls
Procedure: Observation
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
Other Names:
  • Comparison group
Experimental: Patients infused with stem cells
Procedure: Application of Stem Cells
IV infusion of autologous stem cells within the first 48 hours after birth.
Other Names:
  • IV infusion of autologous cord and placental cord blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Stem Cell Infusion at 1 week after discharge
Time Frame: 1 week
Clinical assessment, including the Amiel-Tison Neurological Assessment
1 week
Effects of Stem Cell Infusion at 1 year after discharge
Time Frame: 1 year
Clinical assessment, including the Amiel-Tison Neurological Assessment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Consuelo Mancias-Guerra, MD, Hospital Universitario Dr. Jose E. Gonzalez
  • Study Director: Alma R Marroquin-Escamilla, MD, Hospital Universitario Dr. Jose E. Gonzalez
  • Study Chair: David Gómez-Almaguer, MD, Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 9, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE-11-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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