Autologous Stem Cells in Newborns With Oxygen Deprivation

Not Applicable

• Conditions: Apgar; 0-3 at 1 Minute; Metabolic Acidosis; Hypoxia, Brain; Multiple Organ Failure
• Interventions: Procedure: Observation; Procedure: Application of Stem Cells

• Registration Number: NCT01506258
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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 Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-09
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19
• Primary Completion: 2013-01
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients not infused with stem cells	Observation	Historic Controls
Patients infused with stem cells	Application of Stem Cells	-

Primary Outcome Measures

Name	Time	Method
Effects of Stem Cell Infusion at 1 week after discharge	1 week	Clinical assessment, including the Amiel-Tison Neurological Assessment
Effects of Stem Cell Infusion at 1 year after discharge	1 year	Clinical assessment, including the Amiel-Tison Neurological Assessment

Trial Locations

Locations (1)

Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico