Autologous Stem Cells in Newborns With Oxygen Deprivation

Hospital Universitario Dr. Jose E. Gonzalez

Status: Unknown

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

Treatments: Procedure: Application of Stem Cells; Procedure: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT01506258

HE-11-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Patients not infused with stem cells

No Intervention group

Description:

Historic Controls

Treatment:

Procedure: Observation

Patients infused with stem cells

Experimental group

Treatment:

Procedure: Application of Stem Cells