Clinical trial NCT01506258: Autologous Stem Cells in Newborns With Oxygen Deprivation
Official title: Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apgar; 0-3 at 1 Minute
Metabolic Acidosis
Hypoxia, Brain
Multiple Organ Failure
Keywords: CD34+
perinatal hypoxia
autologous hematopoietic stem cells
cord and placental blood
cerebral palsy
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2012-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of Stem Cell Infusion at 1 week after discharge
timeFrame: 1 week
measure: Effects of Stem Cell Infusion at 1 year after discharge
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Consuelo Mancias-Guerra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Alma R Marroquin-Escamilla, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: David Gómez-Almaguer, MD
role: STUDY_CHAIR
References: