Status:
UNKNOWN
Autologous Stem Cells in Newborns With Oxygen Deprivation
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Apgar; 0-3 at 1 Minute
Metabolic Acidosis
Eligibility:
All Genders
37-42 years
Phase:
NA
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 scenari...
Eligibility Criteria
Inclusion
- 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
- Neurodegenerative, autoimmune or genetic disease
- Active infection at birth
- Informed Consent not signed
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01506258
Start Date
January 1 2012
End Date
April 1 2013
Last Update
January 19 2012
Active Locations (1)
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1
Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico, 64460