Autologous Stem Cells in Newborns With Oxygen Deprivation

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Procedure: Application of Stem Cells
* Procedure: Observation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients not infused with stem cells<br>Historic Controls | Procedure: Observation<br>* Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.<br>* Other names: Comparison group;|
| Experimental: Patients infused with stem cells<br> | Procedure: Application of Stem Cells<br>* IV infusion of autologous stem cells within the first 48 hours after birth.<br>* Other names: IV infusion of autologous cord and placental cord blood;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CD34+, perinatal hypoxia, autologous hematopoietic stem cells, cord and placental blood, cerebral palsy