Clinical Trial: Autologous Stem Cells in Newborns With Oxygen Deprivation

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Universitario Dr. Jose E. Gonzalez

Dates:
Date Received: January 5, 2012
Date Started: January 2012
Date Completion: April 2013
Last Updated: January 18, 2012
Last Verified: January 2012