Autologous Stem Cells in Newborns With Oxygen Deprivation
Recruitment status was Recruiting
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.
Apgar; 0-3 at 1 Minute
Multiple Organ Failure
Procedure: Application of Stem Cells
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia|
- 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
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
No Intervention: Patients not infused with stem cells
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
Other Name: Comparison group
|Experimental: Patients infused with stem cells||
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506258
|Contact: Consuelo Mancias-Guerra, MD||+52 81 83 48 61 36 ext firstname.lastname@example.org|
|Contact: Alma R Marroquin-Escamilla, MD||+52 81 83 48 61 email@example.com|
|Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez||Recruiting|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Contact: Consuelo Mancias-Guerra, MD +52 01 86 75 67 18 firstname.lastname@example.org|
|Sub-Investigator: Alma R Marroquin-Escamilla, MD|
|Sub-Investigator: Ana Cecilia Sosa-Cortez, MD|
|Sub-Investigator: Sagrario L Valdes-Burnes, MD|
|Sub-Investigator: Barbara G Cardenas-del Castillo, MD|
|Sub-Investigator: Adriana Nieto-Sanjuanero, MD|
|Sub-Investigator: Oscar Gonzalez-Llano, MD|
|Sub-Investigator: Laura Villarreal-Martinez, MD|
|Sub-Investigator: Laura M Nuño-Vazquez, MD|
|Sub-Investigator: Josue E Rios-Solis, MD|
|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|