Autologous Stem Cells in Newborns With Oxygen Deprivation

This study is currently recruiting participants.

Verified January 2012 by Hospital Universitario Dr. Jose E. Gonzalez

Sponsor:

Information provided by (Responsible Party):

Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

ClinicalTrials.gov Identifier:

NCT01506258

First received: January 5, 2012

Last updated: January 18, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 5, 2012

Last Updated Date

January 18, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effects of Stem Cell Infusion at 1 week after discharge [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Clinical assessment, including the Amiel-Tison Neurological Assessment
Effects of Stem Cell Infusion at 1 year after discharge [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Clinical assessment, including the Amiel-Tison Neurological Assessment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01506258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Autologous Stem Cells in Newborns With Oxygen Deprivation

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: Application of Stem Cells
IV infusion of autologous stem cells within the first 48 hours after birth.

Other Name: IV infusion of autologous cord and placental cord blood
Procedure: Observation
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.

Other Name: Comparison group

Study Arm (s)

No Intervention: Patients not infused with stem cells
Historic Controls

Intervention: Procedure: Observation
Experimental: Patients infused with stem cells
Intervention: Procedure: Application of Stem Cells

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

37 Weeks to 42 Weeks

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Consuelo Mancias-Guerra, MD	+52 81 83 48 61 36 ext 413	consuelo@mancias.com
Contact: Alma R Marroquin-Escamilla, MD	+52 81 83 48 61 36	arme25@yahoo.com

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT01506258

Other Study ID Numbers ^ICMJE

HE-11-011

Has Data Monitoring Committee

Yes

Responsible Party

Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

Study Sponsor ^ICMJE

Hospital Universitario Dr. Jose E. Gonzalez

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Hospital Universitario Dr. Jose E. Gonzalez

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top