Multiple Organ Failure Clinical Trial
Official title:
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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