NCT01506258

Autologous Stem Cells in Newborns With Oxygen Deprivation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 37 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2012-01-09
• Last updated: 2012-01-19

Locations

1 site across 1 country: Mexico