Autologous Stem Cells in Newborns With Oxygen Deprivation
Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJanuary 19, 2012
January 1, 2012
1 year
January 5, 2012
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effects of Stem Cell Infusion at 1 week after discharge
Clinical assessment, including the Amiel-Tison Neurological Assessment
1 week
Effects of Stem Cell Infusion at 1 year after discharge
Clinical assessment, including the Amiel-Tison Neurological Assessment
1 year
Study Arms (2)
Patients not infused with stem cells
NO INTERVENTIONHistoric Controls
Patients infused with stem cells
EXPERIMENTALInterventions
IV infusion of autologous stem cells within the first 48 hours after birth.
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Neurodegenerative, autoimmune or genetic disease
- Active infection at birth
- Informed Consent not signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Hematology Professor
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 9, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2013
Study Completion
April 1, 2013
Last Updated
January 19, 2012
Record last verified: 2012-01