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Autologous Stem Cells in Newborns With Oxygen Deprivation

Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01506258
Enrollment
20
Registered
2012-01-09
Start date
2012-01-31
Completion date
2013-04-30
Last updated
2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apgar; 0-3 at 1 Minute, Hypoxia, Brain, Metabolic Acidosis, Multiple Organ Failure

Keywords

CD34+, perinatal hypoxia, autologous hematopoietic stem cells, cord and placental blood, cerebral palsy

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 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.

Interventions

PROCEDUREApplication of Stem Cells

IV infusion of autologous stem cells within the first 48 hours after birth.

PROCEDUREObservation

Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
No

Inclusion criteria

* 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 criteria

* Neurodegenerative, autoimmune or genetic disease * Active infection at birth * Informed Consent not signed

Design outcomes

Primary

MeasureTime frameDescription
Effects of Stem Cell Infusion at 1 week after discharge1 weekClinical assessment, including the Amiel-Tison Neurological Assessment
Effects of Stem Cell Infusion at 1 year after discharge1 yearClinical assessment, including the Amiel-Tison Neurological Assessment

Countries

Mexico

Contacts

Primary ContactConsuelo Mancias-Guerra, MD
consuelo@mancias.com+52 81 83 48 61 36
Backup ContactAlma R Marroquin-Escamilla, MD
arme25@yahoo.com+52 81 83 48 61 36

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026