Autologous Stem Cells in Newborns With Oxygen Deprivation
NCT ID: NCT01506258
Last Updated: 2012-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2012-01-31
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
NCT01284673
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
NCT02881970
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
NCT03696745
Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy
NCT02434965
Autologous Cord Blood Cells for Brain Injury in Term Newborns
NCT01649648
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients not infused with stem cells
Historic Controls
Observation
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
Patients infused with stem cells
Application of Stem Cells
IV infusion of autologous stem cells within the first 48 hours after birth.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Application of Stem Cells
IV infusion of autologous stem cells within the first 48 hours after birth.
Observation
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* Active infection at birth
* Informed Consent not signed
37 Weeks
42 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Consuelo Mancias Guerra
Pediatric Hematology Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Consuelo Mancias-Guerra, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Dr. Jose E. Gonzalez
Alma R Marroquin-Escamilla, MD
Role: STUDY_DIRECTOR
Hospital Universitario Dr. Jose E. Gonzalez
David Gómez-Almaguer, MD
Role: STUDY_CHAIR
Hospital Universitario Dr. Jose E. Gonzalez
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HE-11-011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.